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Abstract

People’s sexual orientation and gender-typical childhood behaviors like what toys they play with, who they play with, and what activities they do can be very different between sexes and even within each sex. It is thought that animals that are exposed to gonadal steroids, especially testosterone and its metabolites, when they are young change their behavior in ways that show sex differences. Pregnant women who take steroid hormones can be more likely to have sex-typed childhood behaviors that predict their sexual orientation later in life, according to this study. At least in some people, testosterone exposure during pregnancy may have an effect on their sexual orientation and the development of sex-type interests during childhood. While hormones have been linked to early development, it looks like there are many ways to get to a certain sexual orientation, not all of which involve hormones.

Keywords: Testosterone, Fetal development, Gonadal steroids, and Sexual orientation,

Research

Introduction

The sexual orientations of men and women, as well as people of both sexes, are very different. If you’re male, you’re more likely than women to be sex-crazed or sex-crazed. There is also a lot of variation in each sex. Several women are androphiles, but not all of them are. The whole reason why people have different sexual orientations isn’t known. It is thought that testosterone is important in the development of most, if not all, behavioral sex differences in other species. The extreme sex difference suggests that testosterone, specifically, is important. Men and women have the same primordial gonads when they are born (Sabo:AWS, n.d.). They grow into testes or ovaries based on their genes. Sex determination is how you figure out who you are (Fisher et al., 2018). Sexual differentiation happens when the gonads mature into testes and ovaries, and their hormones, especially testicular hormones, affect how the body looks as a male or female.

Neonatal or parenatal exposure to testicular hormones results in male-typical development. Female-typical development is a result of a testicular hormone deficiency. This demonstrates that female growth does not require ovarian hormones, which will be discussed in further depth later. According to Bütikofer et al. (2019), the scientific evidence supports this notion for a wide variety of brain regions and behaviors that are significantly different between male and female animals on average. If testosterone and other hormones make you feel sexually attracted, you should read this study. It will demonstrate that gonadotropins (natural hormones) have an effect on human sexual orientation based on animal research. We’ll examine the following study to see how it attempts to determine how an individual’s sexual orientation is influenced by their early endocrine environment. Finally, some future research directions will be discussed.

Problem of the Study

There is overwhelming evidence that gonadal steroids play a big role in the development of human sexual orientation and sex-based behaviors in childhood. The whole reason why people have different sexual orientations isn’t known. It is thought that testosterone is important in the development of most, if not all, behavioral sex differences in other species. The extreme sex difference suggests that testosterone, specifically, is important. In other articles in this special edition, we’ve talked more about some of the things we talked about here. For example, some writers will talk about the genetic and neurological factors that lead to different types of sexual behavior in non-human animals that have been studied in the beginning (Luoto, Krams, and Rantala, 2019). The research topic’s main idea is that prenatal hormone exposure can cause problems with gender identity and intersex people during adolescence, as well as problems with gender identity and intersex people. Each person’s genes were looked at individually, which led to some interesting results that haven’t been repeated (Bütikofer et al., 2019). A lot of people who are intersex don’t know what gender they are, and proxy indicators for prenatal hormone exposure don’t show strong trends in transgender communities, according to research. So, I’d like to do the gene study again and see if the results are different this time around. One of the ways I came up with my hypothesis was to do non-experimental research that found cause and effect relationships that could be turned into an experimental hypothesis.

Hypothesis

Each study topic has the same problems and design constraints at the heart of it. The next sections can look at both theoretical and practical aspects of how to do a good job of examining sex differences. Many studies have used the methods or remedies that have been suggested for each problem. There are two important things to think about while hypothesizing knowledge in this study:

i. How are men and women being different in this way?

ii. When they were testing, were gonadal steroids used to make the difference?

Methodology


Participants will be chosen for a long-term study of how prenatal testosterone affects the development of babies. In this study, there aren’t likely to be any big differences in predictor or control factors between the bigger and smaller groups of people who took part in it. Using backward stepwise linear regression, the data will be looked at. All prenatal testosterone values for both sexes will be combined, and the results will be shown. SPSS will be used to do the analysis. The program is advisable in this case since it saves time and generates frequency distribution tables on a particular survey conducted.

Discussion

For this reason, looking into how heterogeneity in adult sexual orientation came to be should help us understand how heterogeneity in adult sexual orientation came to be. Exposure to androgens during pregnancy has been shown to change the preferences of children for sex-typical toys, activities, and playmates. According to the study, girls who were exposed to high testosterone levels before they were born had a greater preference for toys, playmates, and activities that were more like those of boys. These findings should support the idea that having androgens in the body while pregnant makes one more likely to want more activities when you’re older. Some women who took hormones while pregnant may have had kids who have sex-type interests, based on research from women who took hormones for medical reasons while pregnant (Bütikofer et al., 2019). They have more male- or less female-typical behavior if their moms used androgenic progestins while they were pregnant, while kids whose moms used anti-androgenic progestins show the opposite.

Conclusion

People who have the same androgen-deficient condition have very different sexual orientation outcomes. This, as well as the apparent role of puberty virilization or cultural influences on sexual orientation in these illnesses, are important to note. The way a person looks may have an effect on their sexual orientation, at least in some cases People who have the same androgen-deficient condition have very different sexual orientation outcomes. This, as well as the apparent role of puberty virilization or cultural influences on sexual orientation in these illnesses, are important to note. The way a person looks may have an effect on their sexual orientation, at least in some cases. It has long-term physical consequences, such as increased breasts and penises, as well as long-term repercussions on the brain and body’s reproductive capabilities. Future research may examine novel methods for measuring hormone levels in healthy adolescents during their formative years. Over the last decade or two, considerable study has been conducted on a variety of behaviors and other characteristics associated with sex differences. This demonstrates how fascinating it is to discover how fascinating these things are. Additionally, testosterone levels can be determined in amniotic fluid samples. This data collection contains only women who were referred for amniocentesis for medical reasons. This is not to say that this data set represents all women.

References

Sabo:AWS, A.
https://www.gcumedia.com/digital-resources/cengage/2011/experimental-psychology_ebook_7e.php

Bütikofer, A., Figlio, D. N., Karbownik, K., Kuzawa, C. W., & Salvanes, K. G. (2019). Evidence that prenatal testosterone transfer from male twins reduces the fertility and socioeconomic success of their female co-twins. Proceedings of the National Academy of Sciences, 116(14), 6749-6753.

Fisher, A. D., Ristori, J., Morelli, G., & Maggi, M. (2018). The molecular mechanisms of sexual orientation and gender identity. Molecular and cellular endocrinology, 467, 3-13.

Luoto, S., Krams, I., & Rantala, M. J. (2019). A life history approach to the female sexual orientation spectrum: Evolution, development, causal mechanisms, and health. Archives of Sexual Behavior, 48(5), 1273-1308.

Wang, Y., Wu, H., & Sun, Z. S. (2019). The biological basis of sexual orientation: How hormonal, genetic, and environmental factors influence to whom we are sexually attracted. Frontiers in neuroendocrinology, 55, 100798.

Literature Review

An Investigation into the Feasibility of Intensive Cognitive

Behavioural Therapy

A thesis submitted to The University of Manchester for the
degree of Doctor of Clinical Psychology

in the Faculty of Biology, Medicine and Health

2019

Lauren Hampson

School of Health Sciences
Division of Psychology and Mental Health

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2

Table of Contents

Figures and Tables ………………………………………………………………………………………. 5

Table of Appendices ……………………………………………………………………………………. 6

Word Counts ………………………………………………………………………………………………. 8

Overall Abstract …………………………………………………………………………………………. 9

Declaration ………………………………………………………………………………………………. 10

Copyright Statement ………………………………………………………………………………….. 10

Acknowledgments …………………………………………………………………………………….. 11

Dedication ……………………………………………………………………………………………….. 12

Introduction to Paper I ……………………………………………………………………………. 13

Paper I Systematic Review ………………………………………………………………………. 14

1. Abstract ……………………………………………………………………………………………….. 15

2. Introduction ………………………………………………………………………………………….. 16

2.1 Mental Health and Psychological Distress ………………………………………………. 16

2.2 Cognitive Behavioural Therapy …………………………………………………………….. 17

2.3 Components of Cognitive Behavioural Therapy ………………………………………. 18

2.4 Clinical Guidelines for Delivery of CBT ………………………………………………… 19

2.5 Intensive CBT ……………………………………………………………………………………… 21

2.6 Review Aims ………………………………………………………………………………………. 22

3. Method …………………………………………………………………………………………………. 23

3.1 Review Protocol ………………………………………………………………………………….. 23

3.2 Search strategy ……………………………………………………………………………………. 23

3.3 Inclusion Criteria …………………………………………………………………………………. 25

3.4 Quality Assessment ……………………………………………………………………………… 25

3.5 Analysis of Studies ………………………………………………………………………………. 26

4. Results …………………………………………………………………………………………………. 28

4.1 Description of Papers …………………………………………………………………………… 28

4.2 Quality of Studies ………………………………………………………………………………… 34

4.3 Participants …………………………………………………………………………………………. 36

4.4 Characteristics of Intensive CBT …………………………………………………………… 36

4.5 Effects of Intensive CBT ………………………………………………………………………. 37

4.6 Long Term Follow Up ………………………………………………………………………….. 43

4.7 Acceptability ………………………………………………………………………………………. 43

3

5. Discussion ……………………………………………………………………………………………. 45

5.1 Summary of Evidence ………………………………………………………………………….. 45

5.2 Strengths and Limitations ……………………………………………………………………… 48

5.3 Clinical Implications and Future Directions ……………………………………………. 50

5.4 Conclusions ………………………………………………………………………………………… 52

6. References ……………………………………………………………………………………………. 53

Introduction to Paper II …………………………………………………………………………… 62

Paper II Research Study ………………………………………………………………………….. 63

1. Abstract ……………………………………………………………………………………………….. 64

2. Introduction ………………………………………………………………………………………….. 65

3. Method …………………………………………………………………………………………………. 69

3.1 Study Design ………………………………………………………………………………………. 69

3.2 Participant Sample ……………………………………………………………………………….. 69

3.3 Inclusion Criteria …………………………………………………………………………………. 69

3.4 Recruitment ………………………………………………………………………………………… 70

3.5 Procedure ……………………………………………………………………………………………. 72

3.6 Measures …………………………………………………………………………………………….. 72

3.7 Intervention ………………………………………………………………………………………… 75

3.8 Data Analysis ……………………………………………………………………………………… 77

3.9 Ethical Approval ………………………………………………………………………………….. 78

4. Results …………………………………………………………………………………………………. 80

4.1 Demographic and Clinical Characteristics ………………………………………………. 80

4.2 Feasibility Outcome Measures (Hypothesis One) …………………………………….. 80

4.3 Clinical Outcome Measures (Hypothesis Two) ……………………………………….. 84

5. Discussion ……………………………………………………………………………………………. 87

5.1 Acceptability and Feasibility …………………………………………………………………. 87

5.2 Clinical Outcome …………………………………………………………………………………. 90

5.3 Strengths and Limitations ……………………………………………………………………… 92

5.4 Further Clinical and Research Considerations …………………………………………. 93

6. References ……………………………………………………………………………………………. 95

4

Introduction to Paper III ……………………………………………………………………….. 102

Paper 3: Critical Reflection Paper ………………………………………………………….. 103

Overview …………………………………………………………………………………………………. 104

1. Paper I: Systematic Review …………………………………………………………………… 105

1.1 Rationale for the Review …………………………………………………………………….. 105

1.2 Scoping and Database Searching………………………………………………………….. 106

1.3 Quality Appraisal ………………………………………………………………………………. 107

1.4 Synthesising Results …………………………………………………………………………… 108

1.5 Limitations ………………………………………………………………………………………… 108

1.6 Clinical Implications and Future Directions ………………………………………….. 109

1.7 Conclusions ………………………………………………………………………………………. 110

2. Paper II: Empirical Study ……………………………………………………………………… 111

2.1 Study Aims and Rationale …………………………………………………………………… 111

2.2 Development Stage …………………………………………………………………………….. 111

2.3 Recruitment Considerations ………………………………………………………………… 112

2.4 Conducting Research in Prison ……………………………………………………………. 114

2.5 The Role of Clinical Psychology in Prison ……………………………………………. 117

2.6 Delivering Psychological Intervention in Prison …………………………………….. 118

2.7 System-level Considerations ……………………………………………………………….. 120

2.8 Final Considerations …………………………………………………………………………… 121

3. References ………………………………………………………………………………………….. 123

Appendices ……………………………………………………………………………………………. 128

1. Paper I: Systematic Review …………………………………………………………………… 128

2. Paper II: Empirical Study ……………………………………………………………………… 144

3. Paper III: Critical Review Paper…………………………………………………………….. 229

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Figures and Tables

Paper I: Systematic Review

Figure 1: A PRISMA Chart to Outline Screening and Eligibilty Procedures …….. 24

Table 1: Characteristics of Studies …………………………………………………………. 29-33

Table 2: Component and Global Quality Ratings using the EPHPP …………………. 35

Table 3: Changes to Mean Scores and Calculated Effect Sizes for Psychological

Distress Associated with Mental Health ……………………………………………………… 39

Table 4: Changes to Mean Scores and Calculated Effect Sizes for Pain ………….. 41

Table 5: Changes to Mean Scores and Calculated Effect Sizes for Distress

following Trauma ……………………………………………………………………………………… 42

Paper II: Empirical Paper

Figure 1: Consort Diagram of Recruitment and Study Retention …………………….. 71

Figure 2: A Box Plot to Demonstrate Therapists Rating of Adherance to Therapy

……………………………………………………………………………………………………………….. 83

Figure 3: Suicide Ideation as Rated by Participants and Therapists, across all Five

Sessions …………………………………………………………………………………………………… 86

Table 1: An Overview of the Therapeutic Modules Delivered During the

Programme ……………………………………………………………………………………………… 82

Table 2: CSQ Mean Scores and Overall Satisfaction Score ……………………………. 84

Table 3. Mean Scores and Effect Sizes at Baseline and Follow Up………………….. 84

6

Table of Appendices

Paper I: Systematic Review

Appendix 1: Clinical Psychology Review Guidance for Authors ……………….. 129

Appendix 2: EPHPP Quality Tool ………………………………………………………….. 140

Paper II: Empirical Paper

Appendix 3: Archives of Suicide Research Guidance for Authors ………………… 145

Appendix 4: University of Manchester Ethical Approval ……………………………… 147

Appendix 5: Health Research Authority Ethical Approval ……………………………. 149

Appendix 6: Favourable Research and Ethics Committee Letter …………………… 152

Appendix 7: HMPSS Ethical Approval ………………………………………………………. 157

Appendix 8: Clinical Trial Registration ……………………………………………………… 159

Appendix 9: Participant Information Sheet …………………………………………………. 161

Appendix 10: Summary Participant Information Sheet ………………………………… 166

Appendix 11: Informed Consent Form ………………………………………………………. 168

Appendix 12: Prison GP Letter …………………………………………………………………. 171

Appendix 13: The InSPire Programme: What to Expect ………………………………. 173

Appendix 14: Participant Debriefing Sheet …………………………………………………. 176

Appendix 15: Certificate of Completion …………………………………………………….. 178

Appendix 16: Demographics Questionnaire ……………………………………………….. 180

Appendix 17: Additional Study Metrics …………………………………………………….. 185

Appendix 18: Therapist Session Summary Sheet ………………………………………… 187

Appendix 19: Therapist Rating Scale …………………………………………………………. 190

Appendix 20: Client Satisfaction Questionnaire ………………………………………….. 192

Appendix 21: Discharge Summary Sheet …………………………………………………… 196

Appendix 22: Beck Suicide Scale ……………………………………………………………… 198

Appendix 23: The Difficulties in Regulating Emotions Scale ……………………….. 201

Appendix 24: Social Problem Solving Inventory …………………………………………. 207

Appendix 25: Multi-dimensional Scale of Percieved Social Support ……………… 209

Appendix 26: Participant Sessional Measure ………………………………………………. 211

Appendix 27: Therapist Sessional Measure ………………………………………………… 213

Appendix 28: Qualitative Interview Topic Guide ………………………………………… 215

Appendix 29: CBSP Therapy Modules ………………………………………………………. 219

7

Appendix 30: Distress Protocol …………………………………………………………………. 221

Appendix 31: Safe Working Practices and Risk Management Protocol ………….. 223

Paper III: Critical Review

Appendix 32: EPHPP Dictionary ………………………………………………………………. 230

Appendix 33: InSPire Appointment Slips …………………………………………………… 235

8

Word Counts

(excluding abstracts, references, tables, figures and appendices)

Papers

Paper I: Systematic Review

Paper II: Empirical Paper

Paper III: Critical Reflection

Total word count

Word Counts

8456

8275

5966

22, 697

9

Overall Abstract

Background
Paper I: Intensive Cognitive Behavioural Therapy (CBT) is an emerging intervention
for psychological distress and mental health. There is no known review in this area
in an adult population. Paper II: The InSPire programme was developed to deliver
intensive cognitive behavioural suicide prevention (CBSP) therapy within a prison,
to address barriers to long term engagement in previous psychological intervention
studies (i.e. attrition).

Aims
Paper I systematically reviewed studies which have delivered intensive CBT within
an adult population experiencing psychological distress. Paper II aimed to
determine the feasibility of intensive CBSP in a prison, with individuals experiencing
suicidal thoughts and behaviours.

Methods
Paper I was a systematic review of 17 studies delivering intensive CBT across
populations experiencing psychological distress associated with mental health,
addiction, chronic pain and following a traumatic incident. Paper II was a feasibility
case series with single baseline and single follow up. Thirteen individuals consented
to the InSPire programme, delivering an intensive CBSP intervention within a three
week period (five two-hourly sessions were offered). Outcome measures assessed
suicidality (including thoughts of self-harm) and client satisfaction. Psychological
mechanisms associated with suicide were measured, including perceived social
support, emotional regulation and problem solving.

Results
Paper I found promising results in the efficacy and feasibility of intensive CBT,
particularly in the population experiencing distress associated with mental health
difficulties. The review unearthed a number of recommendations for further
research in this field. Paper II found the InSPire programme to be feasible, as
determined by successful recruitment and retention across the study, including
high participant satisfaction. The programme appeared to have an efficacious
benefit for those who took part across all outcomes measured.

Conclusions
Paper I highlights the promising feasibility and efficacy of intensive CBT, yet more
rigorously designed studies (i.e. RCTs) must be conducted before firm conclusions
can be drawn and prior to a future repeat review. Paper II highlighted the potential
benefit of conducting intensive CBSP in prison. Given the limited generalisability of
this study, a larger scale feasibility trial would now be warranted to determine more
conclusive evidence.
Paper III was a critical review paper appraising papers I and II. This included
consideration of the methodological process, strengths and limitations, and
considerations alongside further literature.

10

Declaration

No portion of the work referred to in the thesis has been submitted in support of an
application for another degree or qualification of this or any other university or
other institute of learning.

Copyright Statement

i. The author of this thesis (including any appendices and/or schedules to this
thesis) owns certain copyright or related rights in it (the “Copyright”) and s/he has
given The University of Manchester certain rights to use such Copyright, including
for administrative purposes.
ii. Copies of this thesis, either in full or in extracts and whether in hard or electronic
copy, may be made only in accordance with the Copyright, Designs and Patents Act
1988 (as amended) and regulations issued under it or, where appropriate, in
accordance with licensing agreements which the University has from time to time.
This page must form part of any such copies made. iii. The ownership of certain
Copyright, patents, designs, trademarks and other intellectual property (the
“Intellectual Property”) and any reproductions of copyright works in the thesis, for
example graphs and tables (“Reproductions”), which may be described in this
thesis, may not be owned by the author and may be owned by third parties. Such
Intellectual Property and Reproductions cannot and must not be made available for
use without the prior written permission of the owner(s) of the relevant Intellectual
Property and/or Reproductions. iv. Further information on the conditions under
which disclosure, publication and commercialisation of this thesis, the Copyright
and any Intellectual Property and/or Reproductions described in it may take place is
available in the University IP Policy (see
http://documents.manchester.ac.uk/DocuInfo.aspx?DocID=2442 0), in any relevant
Thesis restriction declarations deposited in the University Library, The University
Library’s regulations (see http://www.library.manchester.ac.uk/about/regulations/)
and in The University’s policy on Presentation of Theses

11

Acknowledgments

I would like to thank the participants for taking part in the InSPire programme.

Involvement has allowed us to further our understanding of psychological therapy

in prison for those experiencing suicidal thoughts and behaviours. Thank you to all

prison and NHS staff who worked alongside us to make this programme possible.

Thank you to Dr Daniel Pratt, for this incredible opportunity, and for the ongoing

inspiration, patience and guidance throughout. Thank you to Dr Charlotte Lennox

for research support and guidance throughout.

Thank you to Minjae Kim for data entry. Thank you to Claire Steele and Megan

McKenna for support with inter-rater reliability. Thank you to Jemma Gaskell,

Martin Parrington and Claire Oakes for support with proof reading.

Thank you to Jessica Killilea, for being my ‘wingman’ on this project, for always

having a listening ear and encouraging voice.

Thank you to the incredible cohort that I have been so lucky to have been a part of

during the three years.

Finally, thank you to Gareth Moore, without whom none of this would be possible.

Thank you for being you.

12

Dedication

To those who have lost their lives to suicide.

To families and friends who have been affected by suicide.

To the individuals who continue to fight every day.

13

Introduction to Paper I

Paper I is a systematic review written in accordance with the author guidance for

submission to the journal Clinical Psychology Review (Appendix 1). The authorship

for this paper will be as follows: Hampson, L., Killilea, J., Lennox, C., & Pratt, D.

(2019).

Previous years have seen the emergence of innovative and adapted formats in the

delivery of Cognitive Behavioural Therapy (CBT), across all clinical populations. The

NHS adapts and shapes services based upon clinical need and cost-effectiveness.

Intensive CBT is one method of therapeutic delivery which has attracted research

interest over the past decade. Although there is one published review in this field

that investigates intensive CBT with children with anxiety disorders, there are no

known equivalent reviews which investigate intensive CBT in an adult population.

This review takes a broader approach into investigating the use of intensive CBT

across clinical populations experiencing psychological distress. This review seeks to

understand more about how intensive CBT has been delivered so far, and the

efficacy of its delivery. This review will be relevant for clinicians delivering CBT, in

highlighting the importance of patient choice in the delivery of services, as well as

providing recommendations in terms of overall service delivery. First and foremost,

this review will provide a foundation for future, larger scale, reviews of this type.

Paper I explores the components of an intensive delivery of CBT, as was delivered in

the research study of Paper II. This gave the author a broader understanding of

what intensive CBT is and the areas in which it has been delivered to date.

14

Paper I Systematic Review

Intensive Cognitive Behavioural Therapy for Psychological

Distress: A Systematic Review

Written in preparation for submission to

Clinical Psychology Review

Word count: 8456 (excluding abstract, tables, figures and references)

15

1. Abstract

Delivery of Cognitive Behavioural Therapy (CBT) has adapted over time in response

to the need for more streamlined services. This systematic review aims to examine

existing literature to understand the primary characteristics and efficacy of

‘intensive’ CBT across clinical populations experiencing psychological distress.

Intensive CBT offers a quicker intervention which is completed in a much shorter

time than the traditional weekly delivery.

Seventeen papers were included in this review. Four categories of clinical

population were defined, including psychological distress associated with mental

health, chronic pain, addiction and following a traumatic incident. Delivery of

intensive CBT differed across the studies. An average of 17 hours of therapy was

received per participant. Studies delivered a variety of different components of

CBT, most often being cognitive restructuring. Effect sizes were promising at post-

intervention and longer term follow-up, particularly within studies investigating

mental health difficulties.

This review has collated information on the delivery of intensive CBT and highlights

the promising results in the efficacy of intensive CBT. However, most studies were

exploratory in design, with small sample sizes and weak methodological quality.

Recommendations are given for larger scale trials of intensive CBT to be conducted

in order to establish a more reliable evidence base.

Key words: Systematic, Review, Intensive, Cognitive Behavioural Therapy.

16

2. Introduction

2.1 Mental Health and Psychological Distress

It is widely reported that one in four people in the UK will experience a mental

health difficulty during their lifespan (Ginn & Horder, 2012), with one in six

reporting symptoms of anxiety or depression within the past week (McManus,

Bebbington, Jenkins, & Brugha, 2016). Mental health retains a significant focus in

the government’s political agenda, as it holds considerable bearing upon rates of

employment, housing, debt and poverty (Mental Health Foundation, 2016). There

are financial consequences both on an individual and societal level. Costs to the UK

economy are substantial and taking into account the associated reduced quality of

life, the cost in England alone in 2010 reached £105.2 billion (Centre for Mental

Health, 2010). Both nationally and globally the investment into resources for

prevention and treatment is outweighed by the cost. Despite this, mental health

remains a political focus, as outlined in many Government initiatives, emphasising

the importance of effective service provision and investment into both physical and

mental health (Department of Health [DH], 2011; Mental Health Taskforce, 2016).

Whilst mental health difficulties are generally captured within a diagnostic

framework, (American Psychiatric Association [APA], 2013), ‘psychological distress’

is a broader term used throughout the literature. Mirowsky (2007) offers an

understanding of ‘distress’ as being beyond concepts or diagnoses, which

essentially captures the emotional suffering experienced by the individual. Ridner

(2004) suggested that psychological distress is most often, although not exclusively,

pre-empted by a stressor for which coping is ineffective. Ridner (2004) defines

psychological distress as the “unique discomforting, emotional state experienced by

an individual in response to a specific stressor or demand that results in harm, either

temporary or permanent, to the person” (p. 539). The description by Ridner (2004)

was the working definition of psychological distress for the current review.

Psychological distress is commonly measured using the General Health

Questionnaire [GHQ] (Goldberg, 1972) or Kessler Psychological Distress Scale [K10]

(Kessler et al., 2002). According to these measures, prevalence of psycho

Literature Review

0

2

Research

Learner

Institution

Course Number and Name

Instructor

Submission Date

Abstract

People’s sexual orientation and gender-typical childhood behaviors like what toys they play with, who they play with, and what activities they do can be very different between sexes and even within each sex. It is thought that animals that are exposed to gonadal steroids, especially testosterone and its metabolites, when they are young change their behavior in ways that show sex differences. Pregnant women who take steroid hormones can be more likely to have sex-typed childhood behaviors that predict their sexual orientation later in life, according to this study. At least in some people, testosterone exposure during pregnancy may have an effect on their sexual orientation and the development of sex-type interests during childhood. While hormones have been linked to early development, it looks like there are many ways to get to a certain sexual orientation, not all of which involve hormones.

Keywords: Testosterone, Fetal development, Gonadal steroids, and Sexual orientation,

Research

Introduction

The sexual orientations of men and women, as well as people of both sexes, are very different. If you’re male, you’re more likely than women to be sex-crazed or sex-crazed. There is also a lot of variation in each sex. Several women are androphiles, but not all of them are. The whole reason why people have different sexual orientations isn’t known. It is thought that testosterone is important in the development of most, if not all, behavioral sex differences in other species. The extreme sex difference suggests that testosterone, specifically, is important. Men and women have the same primordial gonads when they are born (Sabo:AWS, n.d.). They grow into testes or ovaries based on their genes. Sex determination is how you figure out who you are (Fisher et al., 2018). Sexual differentiation happens when the gonads mature into testes and ovaries, and their hormones, especially testicular hormones, affect how the body looks as a male or female.

Neonatal or parenatal exposure to testicular hormones results in male-typical development. Female-typical development is a result of a testicular hormone deficiency. This demonstrates that female growth does not require ovarian hormones, which will be discussed in further depth later. According to Bütikofer et al. (2019), the scientific evidence supports this notion for a wide variety of brain regions and behaviors that are significantly different between male and female animals on average. If testosterone and other hormones make you feel sexually attracted, you should read this study. It will demonstrate that gonadotropins (natural hormones) have an effect on human sexual orientation based on animal research. We’ll examine the following study to see how it attempts to determine how an individual’s sexual orientation is influenced by their early endocrine environment. Finally, some future research directions will be discussed.

Problem of the Study

There is overwhelming evidence that gonadal steroids play a big role in the development of human sexual orientation and sex-based behaviors in childhood. The whole reason why people have different sexual orientations isn’t known. It is thought that testosterone is important in the development of most, if not all, behavioral sex differences in other species. The extreme sex difference suggests that testosterone, specifically, is important. In other articles in this special edition, we’ve talked more about some of the things we talked about here. For example, some writers will talk about the genetic and neurological factors that lead to different types of sexual behavior in non-human animals that have been studied in the beginning (Luoto, Krams, and Rantala, 2019). The research topic’s main idea is that prenatal hormone exposure can cause problems with gender identity and intersex people during adolescence, as well as problems with gender identity and intersex people. Each person’s genes were looked at individually, which led to some interesting results that haven’t been repeated (Bütikofer et al., 2019). A lot of people who are intersex don’t know what gender they are, and proxy indicators for prenatal hormone exposure don’t show strong trends in transgender communities, according to research. So, I’d like to do the gene study again and see if the results are different this time around. One of the ways I came up with my hypothesis was to do non-experimental research that found cause and effect relationships that could be turned into an experimental hypothesis.

Hypothesis

Each study topic has the same problems and design constraints at the heart of it. The next sections can look at both theoretical and practical aspects of how to do a good job of examining sex differences. Many studies have used the methods or remedies that have been suggested for each problem. There are two important things to think about while hypothesizing knowledge in this study:

i. How are men and women being different in this way?

ii. When they were testing, were gonadal steroids used to make the difference?

Methodology


Participants will be chosen for a long-term study of how prenatal testosterone affects the development of babies. In this study, there aren’t likely to be any big differences in predictor or control factors between the bigger and smaller groups of people who took part in it. Using backward stepwise linear regression, the data will be looked at. All prenatal testosterone values for both sexes will be combined, and the results will be shown. SPSS will be used to do the analysis. The program is advisable in this case since it saves time and generates frequency distribution tables on a particular survey conducted.

Discussion

For this reason, looking into how heterogeneity in adult sexual orientation came to be should help us understand how heterogeneity in adult sexual orientation came to be. Exposure to androgens during pregnancy has been shown to change the preferences of children for sex-typical toys, activities, and playmates. According to the study, girls who were exposed to high testosterone levels before they were born had a greater preference for toys, playmates, and activities that were more like those of boys. These findings should support the idea that having androgens in the body while pregnant makes one more likely to want more activities when you’re older. Some women who took hormones while pregnant may have had kids who have sex-type interests, based on research from women who took hormones for medical reasons while pregnant (Bütikofer et al., 2019). They have more male- or less female-typical behavior if their moms used androgenic progestins while they were pregnant, while kids whose moms used anti-androgenic progestins show the opposite.

Conclusion

People who have the same androgen-deficient condition have very different sexual orientation outcomes. This, as well as the apparent role of puberty virilization or cultural influences on sexual orientation in these illnesses, are important to note. The way a person looks may have an effect on their sexual orientation, at least in some cases People who have the same androgen-deficient condition have very different sexual orientation outcomes. This, as well as the apparent role of puberty virilization or cultural influences on sexual orientation in these illnesses, are important to note. The way a person looks may have an effect on their sexual orientation, at least in some cases. It has long-term physical consequences, such as increased breasts and penises, as well as long-term repercussions on the brain and body’s reproductive capabilities. Future research may examine novel methods for measuring hormone levels in healthy adolescents during their formative years. Over the last decade or two, considerable study has been conducted on a variety of behaviors and other characteristics associated with sex differences. This demonstrates how fascinating it is to discover how fascinating these things are. Additionally, testosterone levels can be determined in amniotic fluid samples. This data collection contains only women who were referred for amniocentesis for medical reasons. This is not to say that this data set represents all women.

References

Sabo:AWS, A.
https://www.gcumedia.com/digital-resources/cengage/2011/experimental-psychology_ebook_7e.php

Bütikofer, A., Figlio, D. N., Karbownik, K., Kuzawa, C. W., & Salvanes, K. G. (2019). Evidence that prenatal testosterone transfer from male twins reduces the fertility and socioeconomic success of their female co-twins. Proceedings of the National Academy of Sciences, 116(14), 6749-6753.

Fisher, A. D., Ristori, J., Morelli, G., & Maggi, M. (2018). The molecular mechanisms of sexual orientation and gender identity. Molecular and cellular endocrinology, 467, 3-13.

Luoto, S., Krams, I., & Rantala, M. J. (2019). A life history approach to the female sexual orientation spectrum: Evolution, development, causal mechanisms, and health. Archives of Sexual Behavior, 48(5), 1273-1308.

Wang, Y., Wu, H., & Sun, Z. S. (2019). The biological basis of sexual orientation: How hormonal, genetic, and environmental factors influence to whom we are sexually attracted. Frontiers in neuroendocrinology, 55, 100798.

Literature Review

In PSY-452: Experimental Psychology in Topic 8 you completed the Research Report assignment. In this course you will revise components from the PSY-452 assignment and use those revised components to create a research proposal at the end of this course. You should treat this assignment as a potential portfolio piece or writing sample for future grad school applications or job interview.

In 1,250-1,500 words, revise the literature review from the PSY-452 Research Report.
Using the peer-reviewed journal articles included on your Title and Reference Page assignment submitted in Topic 2, add additional information to the literature review section. Keep in mind the purpose of this literature review is to provide background information and research that is related to the topic being proposed to study. Within the sections being added/revised, make sure to include the following:

  1. Using information from the Identifying Themes in Literature assignment in Topic 2, create headings and subheadings to organize the research in the literature review section. Avoid using direct quotes. Remember you are not writing article summaries.
  2. Expand the list of resources included in the Topic 2 Title Page and Reference assignment by incorporating updated articles to the literature review section. Cite a minimum of 13-15 peer-reviewed journal articles.

Literature Review

  

  • Identify      literature that:
    • Describes       the chosen area of research and provides rationale for the choice.
    • Describes       the significance of the chosen topic:
      • Explain        and justify the implications of the new knowledge for stakeholders,        including community members and those who serve the population.
  • Summarize      sources applicable to the history of the chosen topic:
    • Discuss       historical context and dominant themes in the evolution of the topic;       connect common themes and present counter opinions.
    • Consider       theory in light of seminal works by theorists such as Urie       Bronfenbrenner, Sigmund Freud, B.F. Skinner, Carol Gilligan, Jean Piaget,       Erving Goffman, and Clark Moustakas. 
  • Summarize      sources applicable to the theoretical background of the chosen topic:
    • Provide       information about theoretical underpinnings such as empirical/behavioral       or constructivist and humanistic orientations of the literature reviewed.
    • Consider       theory in light of seminal works by theorists such as Urie       Bronfenbrenner, Sigmund Freud, B.F. Skinner, Carol Gilligan, Jean Piaget,       Erving Goffman, Clark Moustakas, Martha Bernal, and George I. Sanchez.
  • Summarize      sources applicable to best practices for engaging in research:
    • Describe       data-collection strategies, research procedures, and approaches for       conducting and reporting research.
  • Summarize      sources that add significance and relevance to the knowledge base of      psychology:

Literature Review

DQ2
Panna Panch

Health care professionals such as nurses are expected to use current best evidence in their clinical practice. Evidence-based practice (EBP) is an approach that integrates three components in clinical decision-making: current best evidence, clinical expertise, and patient perspective (Gardner, 2016). Evidence-based practice requires a different skillset of the clinical practitioner, namely, the ability to identify, access, appraise, and integrate research or scientific evidence into clinical decisions; Mastery of EBP can be developed over time and serve as a strategy to meet health professionals’ life-long learning needs. Therefore, the development and assessment of EBP knowledge and skills in health professions education are necessary to ascertain foundation knowledge in evidence-based approaches to health care. (Gardner, 2016).

My project aims to enhance the knowledge of patients regarding fall prevention at home .When the outcomes have been measured and evaluated, it may appear as if the project is complete, but work may still need to be done. Dissemination can happen in many forms within my organization and beyond, and it should be part of the planning process for the complete project.

An outcome evaluation can yield a wealth of information about opportunities to improve the project as needed. I might be considering using online feedback methods from patients and their caregivers for the positive or negative feedback regarding safety education given by nurses during hospitalization, how much they learned, and how they are using it in daily practice. Our organization has an online service call “patient portal” where patients place their feedback. As a staff, we have held unit meeting and unit council meeting every month. We express our learning, implement quality practice, and interpret data to improve ourselves to provide quality care.

Reference.

Gardner, A., Lahoz, M. R., Bond, I., & Levin, L. (2016). Assessing the Effectiveness of an Evidence-based Practice Pharmacology Course Using the Fresno Test. American journal of pharmaceutical education, 80(7), 123. https://doi.org/10.5688/ajpe807123

DQ2

Patrick Queisner

Evaluation is a fundamental component of the nursing process. Taught in nursing schools across the nation, evaluation is the last step of the nursing process and allows to identify if the solution has been effective in achieving the goal of the project. In the case of my project, the goal is to educate staff around the benefits of routine administration of normothermic intravenous fluids (IVF) over room temperature in the emergency department. Although the incidence of unplanned hypothermic can be impacted by many factors, relying on quantitative data such as temperatures would not be a good indicator of a change in practice.  

 

Historically, staff routinely administers IVF stored at room temperature as their first choice.  However, normothermic IVF has been shown to be effective in maintaining normothermia (Zaman et al, 2018). This would involve going to the supply room to get the desired IVF before going to the patient room. Although the choice to get IVF from the supply room will still be available, it is possible to increase the stock of the IVF in the warmers.  To evaluate the success of the project, the amount of IVF can be tracked and compared to the previous administration amounts.  Need to increase the par stocked into the warmers will also indicate an increase in usage and a change in nursing practice.    

References

Zaman, S. S., Rahmani, F., Majedi, M. A., Roshani, D., & Valiee, S. (2018). A Clinical Trial of the Effect of Warm Intravenous Fluids on Core Temperature and Shivering in Patients Undergoing Abdominal Surgery. Journal of PeriAnesthesia Nursing33(5), 616–625. https://doi-org.lopes.idm.oclc.org/10.1016/j.jopan.2016.12.010

Literature Review

  

  • Identify      literature that:
    • Describes       the chosen area of research and provides rationale for the choice.
    • Describes       the significance of the chosen topic:
      • Explain        and justify the implications of the new knowledge for stakeholders,        including community members and those who serve the population.
  • Summarize      sources applicable to the history of the chosen topic:
    • Discuss       historical context and dominant themes in the evolution of the topic;       connect common themes and present counter opinions.
    • Consider       theory in light of seminal works by theorists such as Urie       Bronfenbrenner, Sigmund Freud, B.F. Skinner, Carol Gilligan, Jean Piaget,       Erving Goffman, and Clark Moustakas. 
  • Summarize      sources applicable to the theoretical background of the chosen topic:
    • Provide       information about theoretical underpinnings such as empirical/behavioral       or constructivist and humanistic orientations of the literature reviewed.
    • Consider       theory in light of seminal works by theorists such as Urie       Bronfenbrenner, Sigmund Freud, B.F. Skinner, Carol Gilligan, Jean Piaget,       Erving Goffman, Clark Moustakas, Martha Bernal, and George I. Sanchez.
  • Summarize      sources applicable to best practices for engaging in research:
    • Describe       data-collection strategies, research procedures, and approaches for       conducting and reporting research.
  • Summarize      sources that add significance and relevance to the knowledge base of      psychology:

Literature Review

1)Topic Selection Submission ( Regarding Information Technology )

In the box provided below, submit the

  1. The topic you will research for your Literature Review
  2. An explanation of what you plan to research
  3. Why you have chosen this topic (how it relates to your career interests)

Note: Your topic must be something related to your field of study (Information Technology). 

2)Literature Review Sources Submission

Provide a minimum of eight (8) scholarly, peer-reviewed sources in reference format.

3)Literature Review Draft

Submit a draft of your Literature Review using APA format. Following are the requirements for the assignment:

  1. Literature Review must be at least 8 pages, not including the title and reference pages.
  2. Literature Review must use at least 8 sources.
  3. The assignment can not exceed 35% of content used from other sources.Your draft will be examined through Safe Assign to determine the percentage. You will see the score when the assignment is submitted. If it is above 35%, you will need to resubmit the assignment. 

4)Literature Review Final Draft

Submit a final copy of the Literature Review using APA format. Following are the requirements for the assignment:

  1. Literature Review must be at least 8 pages, not including the title and reference pages.
  2. Literature Review must use at least 8 sources.
  3. The assignment can not exceed 35% of content used from other sources.Your draft will be examined through Safe Assign to determine the percentage. You will see the score when the assignment is submitted. If it is above 35%, you will need to resubmit the assignment. 

You must complete all other assignments in the course before submitting your final assignment. 

Literature Review

Vol:.(1234567890)

Journal of Autism and Developmental Disorders (2019) 49:1912–1927
https://doi.org/10.1007/s10803-018-3861-x

1 3

O R I G I N A L PA P E R

A Randomised Controlled Feasibility Trial of Immersive Virtual Reality
Treatment with Cognitive Behaviour Therapy for Specific Phobias
in Young People with Autism Spectrum Disorder

Morag Maskey1 · Jacqui Rodgers1 · Victoria Grahame2,6 · Magdalena Glod1 · Emma Honey2 · Julia Kinnear3 ·
Marie Labus4 · Jenny Milne5 · Dimitrios Minos6 · Helen McConachie6 · Jeremy R. Parr1,2

Published online: 15 February 2019
© The Author(s) 2019

Abstract
We examined the feasibility and acceptability of using an immersive virtual reality environment (VRE) alongside cogni-
tive behaviour therapy (CBT) for young people with autism experiencing specific phobia. Thirty-two participants were
randomised to treatment or control. Treatment involved one session introducing CBT techniques and four VRE sessions,
delivered by local clinical therapists. Change in target behaviour was independently rated. Two weeks after treatment, four
treatment participants (25%) and no control participants were responders; at 6 months after treatment, six (38%) treatment
and no control participants were responders. At 6 months post-treatment, symptoms had worsened for one treatment and five
control (untreated) participants. Brief VRE exposure with CBT is feasible and acceptable to deliver through child clinical
services and is effective for some participants.

Keywords Autism · Anxiety · Phobia · Fear · Virtual reality · Cognitive behaviour therapy

Introduction

Autism spectrum disorder (ASD) occurs in around 1% of
the population and is characterised by social communication
difficulties and repetitive behaviours (American Psychiatric
Association 2013; Baird et al. 2006). Co-existing conditions
are common in ASD (Maskey et al. 2013) including anxiety,
which affects around half of children (Simonoff et al. 2008;

Maskey et al. 2013). In a clinical setting, anxiety is among
the most common treatment referral reasons for young peo-
ple with ASD (Ghaziuddin et  al. 2002). Specific phobia
(defined by DSM-5 as extreme or irrational fear of an object/
situation) is one of the most common anxiety presentations
in ASD (Leyfer et al. 2006; Mattila et al. 2010). Prevalence
rates of 30–64% have been reported (Leyfer et al. 2006; van
Steensel et al. 2011); rates are 5–18% in typically develop-
ing children (Ollendick et al. 2002). The nature of phobias
for children with ASD may be ‘unusual’ or atypical, such
as situation-specific fear (e.g. visiting a particular location),
of everyday objects (toilets, machines, foods), or of people
with certain personal characteristics (Mayes et al. 2013).
Importantly these difficulties have an impact on the daily
lives of the child and family, interfering with education and
learning (Maskey et al. 2014) and have been associated with
higher levels of challenging behaviours (Evans et al. 2005).

There are a range of treatments for phobias in typically
developing individuals, with cognitive behaviour therapy
(CBT) and graded exposure as key therapeutic techniques
(Ollendick et al. 2006). However, these techniques may not
be as effective for some children with ASD. For example,
graded exposure typically begins with imaginal desensiti-
sation; many individuals with ASD experience difficulties

* Jeremy R. Parr
jeremy.parr@ncl.ac.uk

1 Institute of Neuroscience, Sir James Spence Institute
Level 3, Royal Victoria Infirmary, Newcastle University,
Newcastle upon Tyne NE1 4LP, UK

2 Complex Neurodevelopmental Disorders Service,
Northumberland Tyne and Wear NHS Foundation Trust,
Newcastle upon Tyne, UK

3 Newcastle University, Newcastle upon Tyne, UK
4 Business Development and Enterprise, Faculty of Medical

Sciences, Newcastle University, Newcastle upon Tyne, UK
5 Tees Esk and Wear Valley NHS Foundation, Trust, UK
6 Institute of Health and Society, Newcastle University,

Newcastle upon Tyne, UK

1913Journal of Autism and Developmental Disorders (2019) 49:1912–1927

1 3

with imagination (Lind et al. 2014) such as producing and
controlling imaginal scenes. This may be a challenge or bar-
rier to treatment adherence and/or effectiveness. National
Institute for Health and Care Excellence (NICE) ASD man-
agement guidance in the UK specifies that CBT will require
adaptation to increase the likelihood of effectiveness for
individuals with ASD (NICE 2013). Suggested adaptations
include the development of disorder-specific hierarchies,
the use of more concrete visual tactics, incorporation of a
child’s specific interests, and inclusion of parents in treat-
ment (Moree and Davis 2010); additional adaptations may
include psychoeducation about recognising and understand-
ing emotions, problem solving, and a reduced cognitive
component with greater use of behavioural strategies such
as exposure and relaxation. Research indicates that with such
adaptations, CBT based interventions can be successful in
promoting anxiety reduction for individuals on the autism
spectrum (Lang et al. 2010; Ung et al. 2015).

Increasingly, new technologies, such as virtual reality
(VR), are being used with the neurotypical population to
augment traditional psychological treatments (Hollis et al.
2016; Freeman et al. 2017; Valmaggia et al. 2016). VR may
be particularly helpful for the delivery of interventions for
those with ASD because it allows simulations of real world
situations to be created, and newly learned coping skills
can be rehearsed and reinforced in a safe and controlled
environment (Parsons and Cobb 2011). VR has been used
successfully to improve various skills, for example, social
understanding (Mitchell et al. 2007; Kandalaft et al. 2013),
job interview skills (Smith et al. 2014), driving skills (Bian
et al. 2013) and road safety and fire alarm procedures (Jos-
man et al. 2008; Strickland et al. 2007). For people with
ASD and specific phobias, VR may offer an alternative to
usual exposure hierarchies used in traditional CBT, which
typically move through imaginal desensitisation to real life
exposure. VR may facilitate a more gradual exposure to the
feared stimulus in a controlled manner, whilst concurrently
allowing the participant to be supported to develop anxiety
management strategies with a therapist.

Given the potential utility of the combination of CBT
and VR to the treatment of specific phobias for people with
ASD, we aimed to investigate the combination of an immer-
sive virtual reality environment (VRE) alongside therapist-
delivered CBT to reduce anxiety. Maskey et.al. (2014), using
a case study design with nine volunteer children who expe-
rienced specific phobias, reported the preliminary accept-
ability of an immersive VRE, known as the Blue Room,
alongside CBT. The Blue Room is a fully immersive VRE
without the need for a headset or goggles; the therapist
controls the perceived movement through the scene with
an iPad. Each child received four VRE twenty-minute treat-
ment sessions delivered over one week. Of nine volunteer
children, eight children improved in their ability to tackle

their real life specific phobia, as described in vignettes of
behaviour and rated by an expert panel. These improvements
were maintained at 12 months follow up. The specific pho-
bias addressed were related to everyday occurrences, such
as travelling on public transport, and therefore overcoming
these phobias significantly improved families’ daily lives
(Maskey et al. 2014). Limitations included recruitment from
a community based group rather than from clinical health
services, lack of randomisation and a control group, and
treatment delivery by the study team rather than within fami-
lies’ local health services.

In order to provide further evidence, we aimed to trial the
VRE and CBT intervention reported in Maskey et al (2014)
with a larger sample of children who were being seen in
clinical services, randomising them to either a treatment or
control group (delayed treatment). We report the results of
the first Randomised Controlled Trial (RCT) of the Blue
Room VRE intervention. The study aims were to (1) evalu-
ate treatment delivery feasibility, with fidelity, by thera-
pists from two UK National Health Service (NHS) teams;
(2) determine acceptability of outcome measures to young
people and parents; (3) investigate responses to the VRE
treatment; (4) monitor whether initial benefits from treat-
ment persisted.

Methods

Study Design

This was a single blind RCT comparing a virtual reality
treatment for specific phobias in children with ASD with
usual care (immediate and control (delayed) treatment arms).
After consent and baseline measures were taken, participants
were randomised to one of these arms.

The immediate treatment group were followed up at 2
weeks and 6 months after treatment. The control arm com-
pleted outcome measures at these time points. The control
group then received the treatment after completing the meas-
ures at 6 months (see Consort Diagram); after their treat-
ment they were subsequently followed-up at 2 weeks and
6 months post treatment. The immediate treatment group
had one additional follow-up at 12 months post treatment.

Participants and Recruitment

Thirty-two young people with ASD were recruited over a 12
month period from two UK mental health services—North-
umberland, Tyne and Wear NHS Foundation Trust and Tees,
Esk and Wear Valley NHS Foundation Trust.

Inclusion criteria: Age 8–14 years, diagnosis of ASD,
verbally fluent and able to understand instructions to enable

1914 Journal of Autism and Developmental Disorders (2019) 49:1912–1927

1 3

treatment participation and completion of outcome meas-
ures. Verbal fluency and comprehension were determined as
part of usual clinical practice by the child’s clinical consult-
ant, who judged the child’s suitability for the study. All par-
ticipants had a specific phobia as identified during the Anxi-
ety Diagnostic Interview Schedule (ADIS) interview (see
below). Exclusion criteria were participants whose phobia
could not be visually represented and addressed in the Blue
Room (e.g. phobia of injections), children with severe and
complex anxiety disorder, and/or children with a learning
disability that the referring mental health clinician judged
would affect their ability to participate.

The child’s usual mental health clinician initially dis-
cussed the study with the family and then completed
an expression of interest form and the Children’s Global
Assessment Scale score (CGAS—a brief measure of emo-
tional and behavioural functioning, with range 1–100) (Shaf-
fer et al. 1983). All participants had a confirmed ASD diag-
nosis according to DSM-IV or ICD-10 criteria from NHS
multidisciplinary diagnostic teams.

On receiving the Expression of Interest form, a member
of the research team contacted families to evaluate whether
their specific phobia was suitable for treatment and for com-
puter generated, graded scene design. Forty families were
identified by clinicians; five of these did not have a phobia
that could be treated in the Blue Room and three declined
to take part after receiving further information. Thirty-two
families received a preparatory home visit where baseline
measures were completed and the family shown a video
of the Blue Room VRE; written informed consent was
obtained. Table 1 shows the characteristics of participants.
The two groups were well matched for mean age and gender
and on outcomes captured by the standardised measures.
Table 2 shows the specific phobias that were identified by
participants and their families as the target to address during
the Blue Room treatment.

Measures

Baseline Characterisation

The following measures were completed by the participant
and their parent/caregiver at baseline.

Social Communication Questionnaire (SCQ) (Berument
et  al. 1999) A parent-completed 40 item questionnaire to
describe the child’s ASD characteristics. It is used interna-
tionally, and has high sensitivity and specificity for an ASD
diagnosis.

Anxiety Disorders Interview Schedule (ADIS) (Silverman
1996) A widely used standardised clinical interview carried
out with parents; each anxiety area is given a severity rating,

including separation anxiety, social anxiety disorder, spe-
cific phobia, panic disorder, obsessive–compulsive disorder
and generalised anxiety disorder.

Vineland Adaptive Behaviour Scales (VABS) (Sparrow et  al.
2005) This parent interview allows children’s functional
abilities to be compared to age norms (Communication,
Socialisation and Daily Living Skills). We did not undertake
IQ assessment as feasibility must relate to current clinical
practice, where clinicians take pragmatic decisions about
treatment and children’s capabilities rather than basing
treatment access on assessment scores.

Outcome Measures

Maskey et al (2014) reported that Target Behaviour ratings
are appropriate outcome measures of real life change in
behaviours of concern. This is further supported in a review
of the treatment of specific fears and phobias in children
with ASD (Lydon et al. 2015), where target behaviours were
found to be the primary outcome measure in 10 of the 16
studies reviewed. This measure was therefore included as
the main outcome measure, alongside questionnaires, to
investigate the utility of different outcome measures with
this clinical population.

For the treatment and control groups the following out-
come measures were collected:

Target Behaviour rating This measure recorded a rat-
ing of change over time in the specific phobia to be tackled
through Blue Room treatment. The protocol was developed
by the Research Units on Paediatric Psychopharmacology
(RUPP) Autism Network (Arnold et al. 2003). Questions
regarding the child’s specific phobia behaviours, and ques-
tions such as ‘how often?’ and ‘how distressed?’ were asked
in a standard format to the parent, enabling a vignette to
be written. Following an interview about phobia during
the initial home visit, pre-treatment vignettes were writ-
ten prior to randomisation, by the first author (for examples
see Table 5). These baseline vignettes are not rated per se,
but rather serve as a baseline from which Target Behav-
iour change is measured. Follow-up vignettes were written
from telephone interviews with parents, undertaken by the
blinded outcome assessor. All efforts were made to maintain
the assessor as blinded. Each vignette pair (baseline vs post
treatment vignettes) was evaluated for change over time on
a 9 point scale (from ‘normalised’ to ‘disastrously worse’).
An expert panel of raters received training with examples,
before rating the pairs of vignettes. Raters were blind to
group allocation and time point, and each vignette pair was
rated by four different raters. Arnold and colleagues (Arnold
et al. 2003) reported an Intraclass Correlation Coefficient
(ICC) of 0.895 for a panel of 5 experts; in this study ICCs
for the two time points were 0.869 (95% CI 0.775 to 0.930)

1915Journal of Autism and Developmental Disorders (2019) 49:1912–1927

1 3

and 0.935 (95% CI 0.887 to 0.965). The Target Behaviour
rating is reported both dimensionally, and also by categori-
cal cut-score using a mean of 3.0 or less, corresponding to
a rating of ‘definitely improved’ or better, to define positive
treatment response (‘responders’). In addition, a cut-score

of 6.0 or more was used in this study to define those whose
symptoms had worsened compared to baseline.

Spence Children’s Anxiety Scale-parent version (SCAS-
P) and child version (SCAS-C) The SCAS (Spence 1998)
was developed to assess anxiety symptoms in children in

Table 1 Baseline characteristics
of the immediate treatment and
control groups

a SCQ Social Communication Questionnaire
b CGAS Children’s Global Assessment Scale
c ADIS Anxiety Disorders Interview Schedule

Immediate treatment
N (%)

Control group
N (%)

All children
N (%)

Gender
 Male 13 (81.3) 12 (75) 25 (78.1)
 Female 3 (18.8) 4 (25) 7 (21.9)

Age
 Mean (months) 130.13 (28.38) 129.00 (21.51) 129.56 (24.78)
 Range (months) 89–174 90–157 89–174

Ethnicity
 White 16 (100) 14 (87.5) 30 (93.8)
 Non white 2 (12.5) 2 (6.2)

Additional diagnoses
 Any 13 (81.3) 11 (68.8) 24 (67)
 Dyslexia 1 (6.3) 1 (6.3) 2 (6.3)
 Dyspraxia 3 (18.8) 4 (25.0) 7 (21.9)
 ADHD 4 (25.0) 4 (25.0) 8 (25.0)
 Other 5 (31.3) 2 (12.5) 7 (21.9)

Household income
 Above UK mean income 9 (56.3) 9 (56.3) 18 (56.3)
 Below UK mean income 6 (37.5) 7 (43.8) 13 (40.6)
 Prefer not to say 1 (6.3) 0 1 (3.1)

Information about parent who observed treatment
 Mother/Father (includes one grand-

mother)
15/1 (93.8/6.3) 14/2 (87.5/12.5) 29/3 (90.6/9.4)

 Married/cohabiting 12 (75.0) 13 (81.3) 25 (78.1)
 University degree 6 (37.5) 3 (18.8) 9 (28.1)
 Employed 10 (62.5) 9 (56.3) 19 (59.4)

SCQa score ≥ 15/<15 14/1 14/2 29/3
Mean SCQ score (SD) 25.07 (7.69)

(1 missing)
25.06 (7.59) 25.06 (7.51)

(1 missing)
Mean CGASb score (SD) 52 (13.7)

(9 participants)
49 (7.7)
(7 participants)

50.81 (11.26)
(16 participants)

ADISc primary diagnosis
 Specific phobia 14 (87.5) 14 (87.5) 28 (87.5)
 Social phobia 2 (12.5) 2 (12.5) 4 (12.5)
 Number with secondary diagnoses

(mean number of secondary diagnoses
per child)

14 (2.8) 14 (2.8) 28 (2.8)

 Mean Vineland scores (n = 14) (n = 16) (n = 30)
 Communication 73.50 (16.09) 73.63 (11.91) 73.57 (13.76)
 Daily living skills 72.07 (13.68) 65.44 (8.10) 68.57 (11.33)
 Socialisation 63.14 (10.38) 65.00 (14.97) 64.40 (12.27)
 Adaptive behaviour composite 68.43 (11.99) 66.63 (8.53) 67.53 (10.08)

1916 Journal of Autism and Developmental Disorders (2019) 49:1912–1927

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the general population and has 38 items with a 0 (never)
to 3 (always) scale. The measure has been widely used in
ASD studies (Sofronoff et al. 2005; Maskey et al. 2014).
High internal consistency for the total scale score has been
reported (Spence 1998), and both convergent and divergent
validity (Nauta et al. 2004). In the current study, internal
consistency at baseline was α = 0.900 for SCAS-P and
α = 0.863 for SCAS-C.

Fear survey schedule for children—revised (FSSC-R)
(Ollendick 1983) This is an 80 item parent-report question-
naire with an overall intensity and fearfulness score. The
FSSC-R is the most commonly used tool for assessment of
common fears and phobias, with good construct, conver-
gent and divergent validity (Gullone et al. 2000) and strong
test–retest reliability and internal consistency (Burnham and
Gullone 1997). In the current study, internal consistency at
baseline was α = 0.932.

Children’s Assessment of Participation and Enjoyment
(CAPE). This was completed by the child at baseline and 9
months and intended to measure any increase in participa-
tion in community activities. CAPE is a 50 item child-report
of activities, presented pictorially, to assess children’s partic-
ipation in a range of solitary and group voluntary activities.
Reliability and validity of the CAPE was established through
study of 427 children with disabilities (King et al. 2007).

Process Measures

Attendance: whether children attended all sessions was
recorded.

Confidence ratings: during treatment children rated their
confidence at tackling their goal situation at the beginning of

session one, end of session two, beginning of session three
and end of session four. Parents rated their perception of
their child’s confidence at parallel time points. Ratings were
from 0 (not comfortable) to 6 (very comfortable); parent and
child ratings were taken in separate rooms and not shared.
Examples of a confidence scale used are given in a previous
publication (Maskey et al. 2014).

When families were approached but chose not to partici-
pate, ethical permission was granted to pass the following
anonymised data to the research team: CGAS score, age,
gender, ASD diagnosis and type of diagnosis. This was to
allow ‘refusers’ to be characterised and compared with trial
participants.

Randomisation and Masking

Participants were randomly allocated to immediate treatment
group (n = 16) or control group, for whom treatment was
offered after the 6 months outcome measures were admin-
istered (n = 16). Allocation was by computer using a pass-
word-protected Newcastle University Clinical Trials Unit
website. Randomisation was by mixed block design, using
block sizes of two and four, stratified by site. Due to the
nature of the treatment, participants, clinicians and the main
researcher for the study were aware of group allocation.
Participants were randomised and informed after the initial
home visit as to whether or not they were in the immediate
treatment group. Another researcher, blind to treatment allo-
cation, conducted outcome measurements through telephone
discussion of target behaviours with families and receiving
postal questionnaires. Blinding was strictly maintained; this
outcome assessor had no other trial role, no access to docu-
ments and did not attend trial meetings. At each telephone
or postal contact, this outcome assessor reminded parents
she was unaware of group allocation.

Materials

The Blue Room VRE is a patented immersive technology
using interactive computer generated audio visual images
projected onto the walls and ceilings of a 360 degree
screened room (Fig. 1). The room was 4 m3 and the partici-
pant and therapist sit side by side. A therapist remains with
the participant throughout the treatment sessions, deliver-
ing the CBT techniques (described below). Scenes are indi-
vidualised, incorporating an exposure hierarchy related to
the feared stimulus. For example, for dog phobia, adaptions
include the dog’s size, whether on or off a lead, barking,
and proximity to the participant. This gradation allows the
participant to experience levels of mastery in managing their
anxiety and to repeatedly practice this at one level of chal-
lenge before moving to the next (Maskey et al. 2014). The

Table 2 Specific phobias which were addressed (treatment group and
control group)

a Anxiety related to very specific social situations that were identified
by the child and their parents as highly desirable treatment targets

Treatment group phobias Control group phobias

Bananas Dogs (x2)
Wasps/bees (x2) Flying (x2)
Open spaces Wasps/bees
Dogs (x3) Specific chronological time
Lifts Heights/glass elevators (x2)
Fear of the dark Thunder and lightening
Insects Making requestsa

Being looked ata Mascots
Changes in weather Automated toys
Eating in front of other peoplea Fear of the dark
Balloons Travelling in the car
Dolls Toilets
Bats Balloons

1917Journal of Autism and Developmental Disorders (2019) 49:1912–1927

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following link shows a session in progress: https ://www.
youtu be.com/watch ?v=9U-rRC8j c28.

Treatment

Before VR sessions, each participant and parent attended
a 45  minutes session with their allocated therapist. The
therapist was a health professional (for example an assis-
tant psychologist, or a specialist nurse) with experience in
ASD and/or CBT, who had attended the training workshop
(see below). Simplified CBT techniques were introduced,
including: (1) identifying feelings (how different parts of
the body feel; how thoughts, emotions and behaviours are
connected); (2) the concept of a visual ‘feeling thermom-
eter’ using the participant’s words to describe anxiety; (3)
two relaxation exercises (muscle relaxation and deep breath-
ing, with scripts for home practice); (4) identification of the
participant’s positive coping statement, e.g. ‘I can do this’,
‘I’m going to be ok’, to use in the treatment sessions. These
CBT elements were repeated and consolidated during VRE
sessions. The goal for the end of treatment was agreed with
the participant; this goal was used for the confidence rating
charts for parent and participant.

Following scene creation, participants attended 20 min
treatment sessions. Two Blue Room treatment sessions were
completed at one visit, with a fifteen minute break between.
The second two sessions were conducted around one week
later. The therapist allocated to the participant was present
during all sessions. Parents watched treatment via a video

link, and the session content and purpose of activities was
explained. For the first two sessions, a supervising qualified
clinical psychologist attended to observe and give feedback
to the therapist. This supervising therapist also answered any
questions the family had during the session.

Materials for the treatment sessions (the treatment man-
ual, customised visual scales and relaxation scripts) were
provided to therapists. Each Blue Room session started
with a relaxation scene, allowing the participants to become
familiar with the environment, and to practice relaxation
techniques and coping self-statements. The two available
relaxation scenes were of swimming dolphins, and a field
in the country; scenes had soft background music that could
be turned off if requested. The duration the child spent
looking at these scenes and practising relaxation exercises
was at the discretion of the therapist, as the aim was to be
responsive to the needs of individual participants; for most
participants, one cycle of muscle relaxation and breathing
exercises was sufficient at the beginning of each session.
The relaxation scenes were returned to during a session if
the therapist thought the participant’s anxiety was severe
or if the participant was finding it difficult to manage their
anxiety during a particular scene.

Following the relaxation scenes, the participant was intro-
duced to the VRE scene designed for them. The initial scene
was designed to be the lowest level of the exposure hierarchy
for that participant (e.g. a quiet dog on a lead in the dis-
tance). The participant gradually moved through the hierar-
chy; they progressed to an increased level of challenge when

Fig. 1 Picture of the Blue Room virtual reality environment

1918 Journal of Autism and Developmental Disorders (2019) 49:1912–1927

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they were consistently reporting low levels of anxiety (score
of 2 or less on a six point scale) on the visual scale for a
scene, and there was agreement between the participant and
therapist to move on. At each level of the hierarchy, partici-
pants were supported by the therapist to practise techniques
to reduce anxiety, including relaxation exercises, thought
challenging and anxiety monitoring. If anxiety increased as
the scene became more challenging, the therapist suggested
relaxation and breathing exercises, moving to the relaxation
scenes if needed. Progress through the scenes was deter-
mined by the progress participants made towards maintain-
ing low anxiety at each level and was individualised to each
participant. After completing the fourth session, the therapist
spoke with participants and their family regarding graded
real world exposure to the anxiety situation. The therapist
explained the need to gradually introduce the participant to
the feared situation in real life and discussed various steps in
the hierarchy of exposure relevant to the particular phobia.

Therapist Training and Treatment Fidelity
Measurement

Before delivering treatment, local therapists read the manual
and attended a 2 hours, group training workshop delivered
by an experienced child clinical psychologist (author 10).
The manual for the treatment is copyrighted and is available
on request from the corresponding author. Training involved
discussion of why children with ASD may develop anxi-
ety, explanation of the steps in treatment including evolu-
tion over four sessions, review of video material from live
sessions, and individual practice with the tablet computer
in the VRE.

All Blue Room treatment sessions were video recorded. A
sample of 30% of sessions in the immediate treatment group
were rated for fidelity to delivery as per the manual. The
sessions were chosen at random but always included at least
one session conducted by each of the 11 therapists, and an
even spread of VRE sessions 1 to 4. Fidelity was recorded on
a checklist to assess (a) Delivery of CBT best practice and
(b) the manual Content and Structure [checklist designed by
author 2, drawing on sources including Roth & Pilling (Roth
and Pilling 2008)]. Delivery ratings included Techniques
used (9 or 10 elements e.g. collaborative approach, mod-
elling reflection, using relaxation strategies, using praise),
Generic Acceptable components (5 elements e.g. therapeutic
alliance, managing emotional content, appropriate flexibil-
ity) and Undesirable components (6 elements e.g. didactic
approach, allows off-topic deviation); Content and Structure
included around 10 elements (e.g. setting agenda, summa-
rising, scenes presented in increasing levels of difficulty).
Rating definitions and number varied between sessions for
Techniques and Content, as different elements were intro-
duced or became irrelevant. Delivery ratings were: 0 (not at

all), 1 (minimal evidence), 2 (several examples) with ratings
reversed for Undesirable components. Content ratings were:
0 (not covered), 1 (covered insufficiently) and 2 (covered
adequately). Senior co-authors (authors 2, 3 and 10) estab-
lished mean inter-rater agreement at 83.6% for Techniques,
96.0% for Acceptable and 92.2% for Undesirable compo-
nents. Agreement of mean 69.7% (range across raters and
sessions 56–94%) for Content and Structure was lower so
was not rated further. Content rating proved difficult for sev-
eral reasons: the quality of audio in recordings; some aspects
perhaps being covered outside the VR; expectation that CBT
would be flexibly individualised.

Analysis

Analysis was conducted according to a pre-specified sta-
tistical analysis plan. Post hoc testing of the main outcome
measure found sensitive to change in our development study
(Target Behaviour rating) was then conducted to explore
potential efficacy.

Analysis was undertaken by author 4, blind to group sta-
tus and supervised by author 2.

Group equivalence at baseline was investigated using
Fisher’s exact test, Pearson’s chi square and t-tests. Explor-
atory group comparison over time was made for the Tar-
get Behaviour ratings using Mann Whitney U test and chi

LITERATURE REVIEW

In this assignment, students will pull together the capstone project change proposal components they have been working on throughout the course to create a proposal inclusive of sections for each content focus area in the course. For this project, the student will apply evidence-based research steps and processes required as the foundation to address a clinically oriented problem or issue in future practice.

Literature Review

Instructions

For this assessment, submit the current draft of your literature review for instructor feedback and grading. Using your literature search question (LSQ), the annotated bibliography, and the abstracted outline to support your review, identify themes that emerge from your analysis of what we know so far about your topic. Use these themes to describe how your research builds on prior knowledge.

For instance, if your LSQ is What does the literature in psychology tell us about the utility of treating mild depression in adults with a combination of synchronous and asynchronous labyrinth walking and cognitive behavioral therapy? you might discuss literature that covers the themes of exercise and depression, cognitive behavioral therapy and depression, walking meditation and depression, mindfulness and depression, and so on. Do not organize the paper by referencing each article sequentially; your task is to synthesize concepts pertinent to the LSQ from the articles selected for this review.

· Identify literature that:

. Describes the chosen area of research and provides rationale for the choice.

. Describes the significance of the chosen topic:

. Explain and justify the implications of the new knowledge for stakeholders, including community members and those who serve the population.

· Summarize sources applicable to the history of the chosen topic:

· Discuss historical context and dominant themes in the evolution of the topic; connect common themes and present counter opinions.

· Consider theory in light of seminal works by theorists such as Urie Bronfenbrenner, Sigmund Freud, B.F. Skinner, Carol Gilligan, Jean Piaget, Erving Goffman, and Clark Moustakas. 

· Summarize sources applicable to the theoretical background of the chosen topic:

· Provide information about theoretical underpinnings such as empirical/behavioral or constructivist and humanistic orientations of the literature reviewed.

· Consider theory in light of seminal works by theorists such as Urie Bronfenbrenner, Sigmund Freud, B.F. Skinner, Carol Gilligan, Jean Piaget, Erving Goffman, Clark Moustakas, Martha Bernal, and George I. Sanchez.

· Summarize sources applicable to best practices for engaging in research:

· Describe data-collection strategies, research procedures, and approaches for conducting and reporting research.

· Summarize sources that add significance and relevance to the knowledge base of psychology:

· Indicate how the chosen sources help investigators identify topics that are well understood and other topics that represent gaps in the knowledge base and the need for further study.

· Create a scenario that illustrates the need for new research.

· Articulate guidelines of the profession applicable to ethical conduct in research practice:

· Demonstrate ethical conduct associated with the protection of research subject vulnerabilities such as the need for data privacy.

· Identify practices and research guidelines that address respect for individual differences and diversity:

· Address individual variation and diversity within and across groups. For example, when writing about marriage and family therapy, acknowledge research choices that exclude or include subgroups such as gay and lesbian families or families of particular racial, ethnic, or cultural compositions.

· Adhere to APA style and formatting guidelines, including concise and well-organized writing:

· Organize paper to enhance the message and supporting points; writing should reflect the quality and expertise expected for academic work.

· Organize and summarize sources thematically.

Your task is to present current considerations important to investigators and to indicate ramifications for stakeholders who rely on the current knowledge base. Use illustrative examples to explain and highlight key concepts. Good reviewers share evidence-based assessments of the current state of knowledge with their audiences.

This assessment is one component of the research concept paper. You are expected to refine this literature review before submitting the final project. Use the research concept paper template to complete the literature review. There are additional details in the template to help guide the completion of this assessment.

Additional Requirements—

· Formatting: Use the Research Concept Paper Template [DOCX] to complete your assessment. It has been created to reflect the proper structure. To avoid missing content and losing points, please do not modify the template.

· Font: New Times Roman, 12 points, double-spaced, or any other font that complies with current APA guidelines.

· APA: Use APA format and style throughout, including citations.

· Length: The literature review draft assessment should be 5–6 pages, not including references.

Refer to the scoring guide to ensure that you meet all criteria.

Competencies Measured

By successfully completing this assessment, you will demonstrate your proficiency in the course competencies through the following assessment scoring guide criteria:

· Competency 1: Determine the scientific merit of the professional literature.

. Identify the chosen research topic and describe its significance.

· Competency 2: Apply theoretical and research findings from the discipline of psychology to professional and academic activities.

. Explain the theoretical orientation for the research concept.

. Demonstrate an effective understanding of the current state of research and literature on the topic.

. Synthesize research findings to create a new understanding.

. Critique the various methodologies and designs that have been used in prior empirical research related to the chosen research topic.

· Competency 5: Communicate psychological concepts effectively using the professional standards of the discipline.

. Convey purpose, in an appropriate tone and style, incorporating supporting evidence and adhering to organizational, professional, and scholarly writing standards.

· Competency 6: Communicate in a manner that is scholarly, professional, and consistent with expectations for members of the psychological professions.

. Exhibit proficiency in writing and use of APA (7th edition) style.

Literature Review

Review

Implementation of Cognitive Behavioral Therapy in e–Mental
Health Apps: Literature Review

Kerstin Denecke1, Dr rer nat; Nicole Schmid2, MBA, LicPhilPs; Stephan Nüssli1, Dr med
1Institute for Medical Informatics, Bern University of Applied Sciences, Biel, Switzerland
2Suchtfachklinik Zurich, Zurich, Switzerland

Corresponding Author:
Kerstin Denecke, Dr rer nat
Institute for Medical Informatics
Bern University of Applied Sciences
Quellgasse 21
Biel, 2501
Switzerland
Phone: 41 32 321 67 94
Email: kerstin.denecke@bfh.ch

Abstract

Background: To address the matter of limited resources for treating individuals with mental disorders, e–mental health has
gained interest in recent years. More specifically, mobile health (mHealth) apps have been suggested as electronic mental health
interventions accompanied by cognitive behavioral therapy (CBT).

Objective: This study aims to identify the therapeutic aspects of CBT that have been implemented in existing mHealth apps
and the technologies used. From these, we aim to derive research gaps that should be addressed in the future.

Methods: Three databases were screened for studies on mHealth apps in the context of mental disorders that implement techniques
of CBT: PubMed, IEEE Xplore, and ACM Digital Library. The studies were independently selected by 2 reviewers, who then
extracted data from the included studies. Data on CBT techniques and their technical implementation in mHealth apps were
synthesized narratively.

Results: Of the 530 retrieved citations, 34 (6.4%) studies were included in this review. mHealth apps for CBT exploit two
groups of technologies: technologies that implement CBT techniques for cognitive restructuring, behavioral activation, and
problem solving (exposure is not yet realized in mHealth apps) and technologies that aim to increase user experience, adherence,
and engagement. The synergy of these technologies enables patients to self-manage and self-monitor their mental state and access
relevant information on their mental illness, which helps them cope with mental health problems and allows self-treatment.

Conclusions: There are CBT techniques that can be implemented in mHealth apps. Additional research is needed on the efficacy
of the mHealth interventions and their side effects, including inequalities because of the digital divide, addictive internet behavior,
lack of trust in mHealth, anonymity issues, risks and biases for user groups and social contexts, and ethical implications. Further
research is also required to integrate and test psychological theories to improve the impact of mHealth and adherence to the
e–mental health interventions.

(J Med Internet Res 2022;24(3):e27791) doi: 10.2196/27791

KEYWORDS

cognitive behavioral therapy; mHealth; e–mental health; chatbot; mobile phone

Introduction

Background
Mental disorders, including depressive and anxiety disorders,
affect 29% of the global population in their lives [1]. Apart from
the fact that mental disorders have an impact on people’s quality
of life, they are one of the most common causes of occupational

disability [2], resulting in high economic costs. The negative
social aspects experienced by individuals with mental disorders
include the inability to create and maintain lasting relationships
and the stigmatization in society. These factors hamper
individuals’ capacity to act and lead a self-determined life as
members of society, discourage them from seeking professional
help, and possibly reinforce the characteristics of mental

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disorders [3]. Mental disorders are usually treated using
pharmacotherapy or psychotherapy [4]. However, there is a
global shortage of mental health professionals as demand
exceeds service provision. There are 9 psychiatrists per 100,000
people available in high-income countries [5], whereas there is
1 psychiatrist for every 10 million people in low-income
countries [6]. In Europe, a comparative study between Finland
and Spain—both with a similar prevalence of mental health
disorders—showed a significant difference in the number of
available staff resources. In Finland, for example, 13
psychologists were available per 100,000 inhabitants, whereas
in Spain, only 2.9 psychologists were available per 100,000
inhabitants [7]. According to the World Health Organization
(WHO), approximately 45% of people in high-income countries
and 15% of people in low-income countries can access mental
health services [8]. Leaving people with untreated mental
disorders may increase suicide attempts and mortality [9]. Even
if treated, approximately 98% of patients’ change processes
induced by therapy occur outside of therapy sessions in their
daily lives. Therefore, there is a need to provide support and
self-help between therapy sessions, which increases the
availability of cognitive behavioral therapy (CBT) to larger
populations.

To address the issue of limited resources for treating individuals
with mental disorders, e–mental health has gained interest in
recent years, particularly for behavior change using elements
of CBT and self-help (eg, MoodGym [10]). e–mental health is
defined as “mental health services and information delivered
or enhanced through the Internet and related technologies.”
[11]. Numerous studies have shown that e–mental health
interventions are comparable in effectiveness to traditional
face-to-face psychotherapy [12,13], thus providing a possible
solution for people who do not have access to face-to-face
therapy. e–Mental health enables users to learn more about their
mental health condition through self-help services; it empowers
them to strengthen their self-management and improve their
health, sometimes including peer-to-peer support [14]. e–Mental
health, realized as mobile health (mHealth) apps, aims to expand
the availability and quality of mental health treatment. mHealth
apps often ask users to enter data for reflection and awareness
and provide relevant information depending on user input.
Sometimes, they also collect data from wearables. The number
of apps addressing mental health has rapidly increased in recent
years [15,16]. Details on the technical implementation of
mHealth apps are rarely described in scientific papers [17],
although implementation is of utmost importance to enable
patient agency and facilitate self-therapy practices. This study
aims to investigate which CBT techniques are implemented by
which technologies in mHealth apps and derive the research
gaps.

CBT and mHealth Apps
CBT is an “active, problem-focused, and time-sensitive approach
to treatment that aims to reduce emotional distress and increase
adaptive behavior in patients with a host of mental health and

adjustment problems” [15,18]. There are four fundamental
techniques of psychotherapy used in CBT: cognitive
restructuring, behavioral activation, exposure, and problem
solving [15,18]. In cognitive restructuring, therapists support
patients in recognizing, evaluating, and modifying maladaptive
or unhelpful thinking. Behavioral activation helps patients to
actively re-engage in their lives. Exposure comprises systematic
contact with a feared stimulus, whereas problem solving aims
to help patients identify and implement solutions to their
problems. We based our work on the implementation of CBT
in mHealth apps on these 4 fundamental techniques of
psychotherapy.

The efficacy of CBT has been demonstrated in multiple forms
of psychopathology, including anxiety disorders, depression,
and eating disorders [19]. Efficacy in the context of this study
means that the effectiveness of an intervention can be
demonstrated. mHealth apps provide options for practices, which
were formerly elements of therapist–patient interaction; thus,
this provides momentum for new routines and social forms [20]
of coping with mental health problems.

In this study, we aim to assess which technologies are used in
mHealth apps to implement the CBT technique. More
specifically, we seek to answer the following research questions:
for which mental illnesses have CBT-based apps been in use
or tested, which CBT techniques are implemented in mHealth
apps, which technologies are used to implement CBT techniques
in mHealth apps, and which research gaps exist in mHealth apps
for realizing CBT?

Methods

Overview
We answered our research questions using a literature search
and review. We studied which of the 4 fundamental CBT
techniques (cognitive restructuring, problem solving, behavioral
activation, and exposure) have been implemented in mHealth
apps. Furthermore, we investigated the technologies used for
their implementation.

Search Strategy
The PRISMA (Preferred Reporting Items for Systematic
Reviews and Meta-Analyses) criteria guided the conduct and
reporting of our literature search [21]; for the PRISMA checklist,
refer to Multimedia Appendix 1. The search was conducted
between June 6 and June 13, 2020, considering all articles
published during the period of 2007 to 2020, as the first iPhone
was launched in 2007, establishing the technological basis for
mobile apps. A total of 3 databases were consulted to find the
relevant papers. Papers included in PubMed were retrieved
using the search string described in Textbox 1. As we were also
interested in the technical aspects of CBT in mHealth apps, we
additionally searched the libraries of IEEE Xplore and ACM
Digital Library (Textbox 1).

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Textbox 1. Search strings used for database search.

Search strings used to search PubMed

• Cognitive behavioral therapy AND mental health AND (telemedicine ORmobile health OR mhealth OR smartphone) NOT (internet delivered
OR internet-delivered): 287 results with abstract

Search strings used to search IEEE Xplore

• Cognitive behavioral therapy: 65 results

Search strings used to search ACM Digital Library

• Query: (Abstract: cognitive behavioral therapy AND mental health) AND (Abstract: mobile health OR mhealth OR smartphone); Filter: (Article
type: Research Article, Publication date: [1/1/2007 TO *], ACM content: DL): 178 results

Inclusion and Exclusion Criteria
Articles were included in this review if they were dealing with
CBT and mHealth apps, they were primary studies reporting
results, and adults (aged >18 years) were the target population.

Articles were excluded if the target populations for interventions
were military veterans, children, or adolescents. These target
groups differ from the general public. Military veterans have a
significantly higher prevalence of posttraumatic stress disorder
than the average population [22] and often receive care in
specialized institutions. On the other hand, digital resources for
children or adolescents need to address specific cognitive and
developmental issues [23] and cannot be directly compared with
apps for adults. Therefore, we decided to exclude apps that
explicitly targeted these groups from this review. Furthermore,
all papers dealing only with web-based interventions and those
describing only the study protocol without the final results were
excluded.

Eligibility and Data Extraction
To assess the eligibility of the articles, all titles and abstracts
were examined by 2 independent reviewers (KD and SN) in the
first round. In the second round, the full texts of the selected
articles were extracted and carefully analyzed to confirm their
eligibility. Eligibility doubts were discussed until an agreement
was reached. The selected articles were included in the
qualitative synthesis.

Two reviewers (KD, NS) extracted data from the selected studies
regarding CBT techniques, technologies implemented in the
mHealth app, type of mHealth app, considered medical
conditions, and outcome. With CBT techniques, we referred to
the 4 fundamental techniques of psychotherapy applied within
CBT (cognitive restructuring, behavioral activation, exposure,
and problem solving [15]). With technologies in mHealth apps,
we implied technical means used in the apps for realizing
specific functionalities. More specifically, we assessed the
provision of audio and video content, interactive elements (eg,
communication facilities with humans or computer systems
such as chatbots), social network technologies, gamification,
and automatic analysis facilities (eg, for sentiment or emotion
detection, recommendation, and text analysis). Data were
abstracted into a spreadsheet standardized for this review.
Finally, we derived the research gaps in e–mental health from
the results.

Results

Sample
A total of 530 papers were retrieved by our search, as follows:
287 (54.2%) records in PubMed, 65 (12.3%) in IEEE Xplore,
178 (33.6%) in ACM Digital Library, and no duplicates. Of
these 530 papers, 34 (6.4%) papers met the inclusion criteria
and were, therefore, included in the qualitative synthesis (see
the flowchart of the selection procedure in Figure 1). Papers
were excluded during eligibility screening and data extraction
if they described only mock-ups or no apps.

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Figure 1. PRISMA (Preferred Reporting Items for Systematic Reviews and Meta-Analyses) flowchart of the selection procedure.

Characteristics of Studies
Most papers (21/34, 62%) reported randomized controlled trials
(RCTs) in which ≥1 mental health app was tested (Multimedia
Appendix 2). The remaining papers used different study designs.
Of the 34 papers, 4 (12%) only assessed usability through
surveys. For RCTs, the number of involved participants varied
between 30 and 1098, with an average of 333. The studies
designed as surveys involved an average of 135 participants.
We found the largest number of participants (n=3977) in an
observational study [24]. This study did not recruit participants
explicitly but analyzed the use protocols of the app under
consideration. It remains unclear whether these protocols
originated from people with diagnosed mental health problems.

Most studies considered usability [25,26], user satisfaction,
acceptance [24], adherence [27], or engagement as outcome
measures. RCTs mainly studied efficacy, adherence, or
acceptability compared with a control group. In RCTs, e–mental
health interventions were often compared against each other
instead of comparing the app intervention with standard
face-to-face psychotherapy. For example, the efficacy of a

web-based implementation of the Kokoro app was compared
with that of an app-based intervention [28]. Among other things,
outcome measures included the Patient Health Questionnaire–9
or Emotional Self-awareness Scale [29]. Of the 34 papers, 3
(9%) studied the Kokoro app for depression. In these papers,
the effectiveness of the app-based intervention was reported;
the use of the app reduced the symptoms of depression
[28,30,31].

Mental Health Conditions Covered
Most studies (32/34, 94%) focused their research on a user group
with a specific disorder. We classified the disorders according
to the WHO International Classification of Diseases–10th
revision (version 2019) coding system (Table 1). Most studies
(16/34, 47%) used apps that offered support for persons with
depression. Furthermore, there was a wide range of apps that
targeted anxiety disorders; addiction problems; and psychiatric
disorders such as schizophrenia, bipolar disorders, or suicidal
tendencies. These disorders are often treated by CBT, which
can be realized in an mHealth app in contrast to other types of
therapies.

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Table 1. Health conditions examined in the studies (N=34).

Total, n (%)WHOa ICD-10b codeHealth condition

1 (3)F12.1Drug addiction—cannabis

1 (3)F40.0Agoraphobia

1 (3)F60.3Borderline personality

16 (47)F32Depression

2 (6)F50Eating disorder

1 (3)G47Insomnia

2 (6)F29Psychosis

1 (3)F20, F25, and F31Schizophrenia, schizoaffective, or bipolar 1

3 (9)Z72.0Smoking

3 (9)F99Stress

1 (3)R45.8Suicidality

2 (6)N/AcUnknown

aWHO: World Health Organization.
bICD-10: International Classification of Diseases–10th revision.
cN/A: not applicable.

CBT Techniques in mHealth Apps
Apps may have integrated techniques to address different
purposes. We classified the main purposes of the apps as
informational, coach, or therapy. An app was considered
informational when it mainly provided information to the user,
for example, on mental health. Apps were classified as coaches
when suggestions were tailored to the user and their specific
mental health condition or when support in managing a mental
illness was delivered. As therapeutic apps, we grouped apps
that delivered CBT with the aim of creating a therapeutic setting.

We could not identify any apps that were only informational.
Most apps provided information but had additional
functionalities that led to their classification as coach or therapy.
Most (20/34, 59%) apps could be considered as coaches in
mental health. Of the 34 apps, 13 (38%) were classified as
therapy; for 1 (3%) app, this classification was not applicable.
We concluded that CBT-based mHealth apps go beyond patient
education. They support and extend their self-help capabilities.

We identified in the included papers 3 of the 4 fundamental
techniques of psychotherapy applied in CBT (cognitive
restructuring, behavioral activation, exposure, and problem
solving [15]; Multimedia Appendix 3 [24-27,29,30,32-50]).
mHealth apps provided toolkits for cognitive restructuring,
which included diary-keeping functionalities and support in
changing thoughts or tensions. Behavioral activation was
realized by providing information on mental health conditions
by tracking activities or setting goals. Assigning homework to
patients, which is the best practice as a problem-solving
technique [15], was realized in many apps (20/34, 59%) by
providing exercises and activities as strategies to cope with
mental health problems. Direct communication with a therapist,
which is not a CBT technique itself but helps in standard setting
for delivering CBT, was enabled by 6% (2/34) of the apps
included in the review.

Technologies in mHealth Apps for Implementing CBT
When developing mHealth apps for CBT, it is important to
know which technologies are useful and efficient for
implementing different CBT techniques. Interactive elements
were included in 35% (12/34) of apps to realize behavioral
activation and cognitive restructuring. Among other things, we
could identify the following interactive elements: automatic
question answering functionalities, message exchange with the
treatment team, a virtual character that provided information or
explanations, personalization, and persuasion methods
(Multimedia Appendix 4 [24-28,31-37,40-46,50-54]). Of the
34 apps, 3 (8%) provided a conversational agent or chatbot with
which the user could communicate. Chatbot technology was
used to support cognitive restructuring. Methods for automatic
analysis of free textual input (natural language processing) and
machine learning methods (eg, text classification or clustering)
were used to understand user input or personalize
recommendations according to user input. However, these
methods are still rarely used (3/34, 9% papers). Audio and video
were used to provide information or demonstrate exercises such
as meditation exercises (ie, support behavioral activation and
problem solving). Few apps calculated scores such as sentiment
or emotion scores that were shown on a timeline. Sentiment or
emotion scores quantify the sentiment or emotion of a user (eg,
positive and negative sentiment or the strength of an emotion
such as sadness). The following two technologies were
integrated into some apps that aimed to improve the user
experience and adherence: gamification and social networks.
Social aspects were integrated, enabling the user to connect
with other users. This social community aspect was interesting
in the context of depression but also in other mental diseases,
where people often experience loneliness and a lack of social
contact. Gamification and social networks integrated into these
apps did not aim to deliver CBT but, more importantly, aimed
to increase the adherence and attractiveness of using the apps

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[32,51]. Gamification such as collecting jigsaws was used in
24% (8/34) of apps, and audio or video content was provided
by 21% (7/34) of apps. Approximately 15% (5/34) of apps
enabled connections with social networks and communities.

Discussion

Principal Findings

Overview
The main finding of this review is that mHealth apps for CBT
exploit two groups of technologies: (1) technologies that
implement concrete CBT techniques for cognitive restructuring,
behavioral activation, and problem solving and (2) technologies
that aim to increase user experience, adherence, and engagement.
The latter tries to address the current challenge in delivering
CBT, which is insufficient adherence to CBT techniques [55].
A CBT technique that we did not find implemented was
exposure. There is a broad range of technologies used in
mHealth apps to deliver CBT; however, no technology was
used in all apps. However, a trend toward the use of interactive
elements, gamification technologies, and technologies
supporting social activities could be recognized. No app was
purely informational; however, most could be classified as
coaches and a few as therapeutic. There have been attempts to
deliver therapy through such apps [33-35,52]. Most apps target
patients with disorders that are often treated with CBT, such as
depression; anxiety disorders; addiction problems; and
psychiatric disorders such as schizophrenia, bipolar disorders,
or suicidal tendencies.

Mental Illnesses for Which CBT-Based Apps Have Been
Used or Tested
Depression was reported most often in the assessed studies.
Depressive disorders are widespread in all countries and
comorbid with other mental diseases. According to the WHO,
>264 million people of all ages experience depression
worldwide. Thus, the target user group is huge. Depression is
a leading cause of disability worldwide and a major contributor
to the overall global burden of disease. There seems to be a
burden of being able to deliver support to those people, and
mental health apps are obviously comprehensively tested to fill
this gap. Although our review did not deliver much evidence
on the efficacy of mHealth apps in the mental health context,
Khademian et al [56] found that mHealth apps that provide
behavior change strategies, such as CBT and techniques for
behavioral activation, have significant effects on depression,
anxiety, and stress.

Psychiatric diseases such as psychosis or schizophrenia were
also targeted. A challenge with psychiatric diseases is that
critical situations can occur where professional reactions are
essential (eg, to prevent a suicide attempt [57]). mHealth apps
that deliver predefined content cannot react individually to
various situations or specific user needs. There is a need for
mHealth apps without undesired side effects; that is, those able
to respond appropriately in situations of crisis [17].

CBT Techniques Implemented in mHealth Apps
We found that some methods used in standard CBT were
implemented in mHealth apps. Sometimes, it was simply a
digitization of the existing technique; however, there were cases
where mHealth apps offered some benefits compared with the
traditional therapy setting. Thought records or coping cards are
methods used within standard CBT to achieve cognitive
restructuring [15]. These methods are often provided in mHealth
apps, for example, by supporting the keeping of diaries.

Scheduling and monitoring activities are the central components
of behavioral activation in CBT [58]. Behavioral activation
recommends planning activities in the evening before or in the
early morning. As therapy sessions are spread across weeks and
planning tasks are conducted with the therapist, day-to-day
planning is not practiced in traditional therapy settings. With
the use of mHealth technologies, daily planning and engagement
can be supported, and personalized recommendations can be
made [36]. Furthermore, increasing patients’ confidence in their
ability to cope with stress and adversity and their overall coping
skills is a major factor in mHealth apps contributing to the
effects on mental health [29].

Information provision as a means of behavioral activation is
another important aspect realized in many apps. This task
includes teaching patients the basics of their mental health
condition and CBT techniques. Morriss et al [59,60] have shown
that knowledge and understanding of the medical condition are
effective in supporting the everyday coping of patients with
mental illness and can foster compliance of patients to the health
intervention. Furthermore, patients become more competent in
making decisions related to their health through information
provision [61]. As providing information is a repetitive task for
health care providers, an app providing information and teaching
patients on the basics of mental health could save time for health
care providers. Furthermore, the patient can read the information
several times. However, studies show that e–mental health apps
often contain incorrect information [62] and are not necessarily
evidence based.

Assigning homework to patients is the best practice as a problem
solving technique [15]. This aspect of CBT, which is available
in many apps, is realized by providing exercises and activities.
Exposure (imaginal exposure and interoceptive exposure [15])
is a CBT technique that was not represented at all in mental
health apps included in our review. However, recent research
has exploited virtual reality for realizing exposure apps; for
example, to reduce the fear of heights [63]. It is obvious that
there is still potential for developing and testing mHealth apps
that target exposure techniques.

In conclusion, mental health apps that provide CBT support the
performing of repetitive tasks such as keeping a diary or
exercising, which are essential tasks and techniques within CBT
for cognitive restructuring, behavioral activation, and problem
solving [15]. Although these tasks must be realized by patients
as part of their standard therapy, even without mHealth support,
their digitization in mHealth apps can increase adherence, user
engagement, and retention or facilitate learning [64]. A mobile
app is available 24 hours a day. Thus, monitoring and tracking
can be performed at any time and at any place. Records in the

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app cannot get lost as paper-based records do. Reminders can
be sent to the user on a regular basis to ensure that records are
made or activities come into the user’s mind [37].

Technologies Used to Implement CBT in mHealth Apps
Most apps often present information using videos or audio, or
they collect data on activities from a user for behavioral
activation. Social aspects are integrated, enabling the user to
connect with other users. This social community aspect is
interesting not only in the context of depression but also other
mental diseases, where people often experience loneliness and
a lack of social contact. Gamification and social networks
integrated in these apps do not aim to deliver CBT but, more
importantly, aim to increase the adherence and attractiveness
of using these apps [37]. Artificial intelligence, including natural
language processing, language understanding, and chatbot
technology, has been rarely used in available apps. A reason
might be that unforeseen errors or reactions can occur when the
system misinterprets the user input, which might be avoided
[65]. Other studies have shown an increased interest in mental
health chatbots [66] or that chatbots are examples of the next
generation of mental health [17]. However, this was not reflected
in our review. Another reason for the limited inclusion of
artificial intelligence in mental health apps may be related to
medical device regulation, which requires traceability and
increases the demand on the development process.

Research Gaps That Exist in mHealth Apps for Realizing
CBT
After scoping the landscape of mHealth apps that implement
CBT, we summarized the open research issues. There is a need
for the following: RCTs studying the efficacy of the single
technologies implemented in mHealth apps for realizing CBT
techniques; studies on the impact on patients’ agency, including
trust and overreliance; consideration of psychological theories
during mHealth implementation to increase impact and
adherence; and support in recommending or selecting CBT apps
as health interventions.

Although more than half of the analyzed studies reported on
RCTs, which is the state-of-the-art study design for proving the
efficacy of medical interventions [67], these trials often did not
assess the efficacy of the mHealth intervention. Similar results
have been reported by Bauer et al [68]. For chatbots in clinical
psychology, Bendig et al [17] noted that studies on mental health
chatbots mainly assessed feasibility and acceptance. Studies are
needed to assess which technology is well-suited for
implementing a particular CBT technique, as well as for which
mental disorders are mHealth apps efficient. This will help
derive the best practices for implementing CBT techniques in
mHealth. In this context, it is also important to clarify the role
of mHealth apps; f

Literature Review

1)Topic Selection Submission ( Regarding Information Technology )

In the box provided below, submit the

  1. The topic you will research for your Literature Review
  2. An explanation of what you plan to research
  3. Why you have chosen this topic (how it relates to your career interests)

Note: Your topic must be something related to your field of study (Information Technology). 

2)Literature Review Sources Submission

Provide a minimum of eight (8) scholarly, peer-reviewed sources in reference format.

3)Literature Review Draft

Submit a draft of your Literature Review using APA format. Following are the requirements for the assignment:

  1. Literature Review must be at least 8 pages, not including the title and reference pages.
  2. Literature Review must use at least 8 sources.
  3. The assignment can not exceed 35% of content used from other sources.Your draft will be examined through Safe Assign to determine the percentage. You will see the score when the assignment is submitted. If it is above 35%, you will need to resubmit the assignment. 

4)Literature Review Final Draft

Submit a final copy of the Literature Review using APA format. Following are the requirements for the assignment:

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  2. Literature Review must use at least 8 sources.
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Literature Review

Treatment Retention Among Patients
Participating in Coordinated Specialty Care
for First-Episode Psychosis: a Mixed-Methods
Analysis

Jane E. Hamilton, PhD, MPH
Devika Srivastava, PhD
Danica Womack, BS
Ashlie Brown, MEd
Brian Schulz, MEd
April Macakanja, MEd
April Walker, BA
Mon-Ju Wu, PhD
Mark Williamson, MD
Raymond Y. Cho, MD, MSc

Abstract

Young adults experiencing first-episode psychosis have historically been difficult to retain in
mental health treatment. Communities across the United States are implementing Coordinated

Address correspondence to Jane E. Hamilton, PhD, MPH, Department of Psychiatry and Behavioral Sciences, McGovern
Medical School, University of Texas Health Science Center Houston, 1941 East Road, Suite 1204, Houston, TX 77054,
USA. E-mail: Jane.E.Hamilton@uth.tmc.edu.

Mon-Ju Wu, PhD, Department of Psychiatry and Behavioral Sciences, McGovern Medical School, University of Texas
Health Science Center Houston, Houston, TX, USA.

Devika Srivastava, PhD, Harris Center for Mental Health and IDD, Houston, TX, USA.
Ashlie Brown, MEd, Harris Center for Mental Health and IDD, Houston, TX, USA.
Brian Schulz, MEd, Harris Center for Mental Health and IDD, Houston, TX, USA.
April Macakanja, MEd, Harris Center for Mental Health and IDD, Houston, TX, USA.
Mark Williamson, MD, Harris Center for Mental Health and IDD, Houston, TX, USA.
Danica Womack, BS, Department of Psychiatry and Behavioral Sciences, Baylor College of Medicine, Houston, TX,

USA.
April Walker, BA, Department of Psychiatry and Behavioral Sciences, Baylor College of Medicine, Houston, TX, USA.
Raymond Y. Cho, MD, MSc, Department of Psychiatry and Behavioral Sciences, Baylor College of Medicine, Houston,

TX, USA.

Journal of Behavioral Health Services & Research, 2018. 415–433. c) 2018 National Council for Behavioral Health. DOI
10.1007/s11414-018-9619-6

Retention in First Episode Psychosis Treatment HAMILTON ET AL. 415

Specialty Care to improve outcomes for individuals experiencing first-episode psychosis. This
mixed-methods research study examined the relationship between program services and treatment
retention, operationalized as the likelihood of remaining in the program for 9 months or more. In
the adjusted analysis, male gender and participation in home-based cognitive behavioral therapy
were associated with an increased likelihood of remaining in treatment. The key informant
interview findings suggest the shared decision-making process and the breadth, flexibility, and
focus on functional recovery of the home-based cognitive behavioral therapy intervention may
have positively influenced treatment retention. These findings suggest the use of shared decision-
making and improved access to home-based cognitive behavioral therapy for first-episode
psychosis patients may improve outcomes for this vulnerable population.

Introduction

Approximately 100,000 adolescents and young adults in the United States (U.S.) experience
first-episode psychosis (FEP) each year.1,2 Early intervention with evidence-based treatment is
recommended for clinical and functional recovery for individuals with FEP.3,4 Research supports
the effectiveness of FEP interventions that include low doses of atypical antipsychotic
medications,5,6 cognitive behavioral therapy (CBT),7–10 family education and support,11–13 and
supported employment and education.14,15 Two elements of early intervention in FEP that are
distinct from standard mental health care include early detection and phase-specific treatment.16

The implementation of effective early interventions for FEP can potentially improve patient
outcomes and reduce the burden of illness associated with psychotic disorders. Coordinated
Specialty Care (CSC) is a recovery-oriented treatment program for individuals experiencing FEP.1

Young adults experiencing FEP have historically been difficult to engage and retain in ongoing
mental health treatment.17 Approximately one third of young adults experiencing FEP delay
treatment for 1 to 3 years.18 Once in treatment, the majority of FEP patients drop out within the
first year of care.18 Causes for this alarmingly high rate of early disengagement from treatment
include poor therapeutic alliance, mistrust of the system, and poor insight into the need for
treatment.17 Treatment disengagement has been shown to result in poor clinical outcomes including
symptom relapse and psychiatric hospitalization.17 Thus, FEP interventions seeking to improve
treatment engagement and retention have the potential to improve clinical outcomes for this
vulnerable group. Research suggests that specialized FEP programs are more successful in
engaging young people in mental health services compared to routine care.19 Additionally, FEP
patients participating in specialized FEP clinics remain in treatment longer compared to those in
standard community clinics.20 To engage and retain FEP patients in treatment, CSC utilizes a team-
based approach and offers a continuum of evidence-based services within a framework of
collaborative treatment planning21 and shared decision-making.1,22 The CSC program aims to
personalize treatment for patients to meet recovery-oriented goals focused on developmental
milestones.1

In 2015, a CSC pilot program was implemented at a community mental health clinic in a large
urban area. An evaluation of the pilot program found that the majority of patients who participated
in the CSC pilot project (n = 129) were retained in mental health treatment for 9 months or more,
compared to 72 days on average for patients participating in standard treatment at another safety-
net clinic within the same mental health system. Compared to the continuum of services CSC
patients participated in, standard treatment patients only participated in psychiatric medication
management and case management services. To compare treatment lengths of stay, treatment as
usual patients were randomly identified from a clinic sample (n = 1503 eligible controls) and
matched with CSC patients for age, gender, and psychotic symptom severity. Because the
relationship between CSC service participation and treatment retention remains underexplored, the

416 The Journal of Behavioral Health Services & Research 46:3 July 2019

current study expands upon prior research by examining treatment retention operationalized as the
likelihood of remaining in the CSC program for 9 months or more.

Methods

Study design

This mixed-methods study examined utilization data for continuously admitted CSC patients and
interview data from interviews conducted with CSC providers after the program was fully
implemented. This study was approved by the University of Texas Health Science Center Houston
Institutional Review Board (IRB) by expedited review and approval.

Setting and population

The study data were obtained as part of the program evaluation of the CSC program
implemented at a safety-net psychiatric outpatient clinic in a large urban area. The following
eligibility criteria were established for participation in the CSC program:

� Received a qualifying diagnosis (or initiated psychiatric treatment) for a psychotic disorder
within the previous 2 years: schizophrenia spectrum diagnosis, major depressive disorder with
psychotic features, or bipolar disorder with psychotic features;

� Be between the ages of 15–30;
� Be uninsured (cannot be enrolled in Medicaid or commercial insurance); and
� Agree to participate in 7 h per month of CSC services.

Coordinated Specialty Care

The CSC program in the current study was implemented as a comprehensive wrap-around
program designed to meet the individualized needs of patients experiencing FEP. 23 The program
incorporated the core concepts of the Prevention and Recovery in Early Psychosis (PREP(®)
program including a focus on early, evidence-based, person-centered, phase-specific, integrated,
continuous, and comprehensive care).24 Clinic-based CSC services included pharmacotherapy with
a psychiatrist trained in FEP treatment. Home-based services included CBT, supported employment
and education, case management, and peer support.

Pharmacotherapy Each patient enrolled in the CSC pilot program was followed by a psychiatrist
specializing in early psychosis recovery. Pharmacotherapy included the use of lower medication
dosages, establishment of medication adherence practices, monitoring for evolving or changing
psychopathology, emphasis on patient functioning, development of healthy lifestyle habits, and
ensuring optimal metabolic and cardiovascular health through regular primary care services in
coordination with the patient’s psychiatric care.25 Shared decision-making was used to guide
interactions between the CSC psychiatrist and patient.26

Home-Based Cognitive Behavioral Therapy Home-based CBT was delivered by a licensed
master’s level psychotherapist with current Texas certification in CBT. The CBT intervention
provided within the CSC program targeted the following domains: illness management, medication
adherence, residual symptoms, trauma, substance use, life skills, and social/occupational/
educational functioning.

Retention in First Episode Psychosis Treatment HAMILTON ET AL. 417

Supported Employment and Education Home-based supported employment and education
services were delivered by an employment and education specialist utilizing a manualized
intervention to assist patients with reentering the workforce or enrolling in school.

Case Management Home-based case management services were provided by a rehabilitation
clinician who assisted patients in accessing community resources and supports and to navigate the
criminal justice system. Specific linkages to medical and social services included primary care
coordination, food stamp application assistance, and housing program application assistance.

Peer Support A FEP-trained peer support specialist participated as a CSC team member and
provided ongoing support to CSC patients. Using shared decision-making, peer specialists worked
with CSC patients to identify treatment options and to explore treatment preferences.

Patient Assessments Each CSC patient was assessed at program admission and every 90 days
during treatment by a CSC clinician who completed a functional assessment, the Adult Needs and
Strengths Assessment (ANSA).27,28 As part of the ANSA, patient functional improvement and the
severity of each patient’s psychosis/thought disturbance were assessed by a psychotherapist for
each CSC patient to plan for ongoing behavioral health needs. To tailor CBT interventions, two
validated measures of psychotic symptoms, the Positive and Negative Syndrome Scale (PANSS)29

and the Brief Psychiatric Rating Scale (BPRS),30 were administered at intake and after 9 months of
service participation. To improve program implementation fidelity, the study investigators
conducted ten onsite PANSS and BPRS assessment trainings with the psychotherapists from
June 2015 through January 2016. Inter-rater reliability was established during four trainings and
ranged from 70 to 85%.

Study protocol, measurements, and outcome measures

To systematically examine predictors of treatment retention for CSC patients, Andersen’s
Behavioral Model of Health Services Use was used to select study variables and to organize the
study findings. The Andersen model conceptual framework includes factors shown in a number of
studies to explain variation in health service use among vulnerable populations.31,32 In adapting the
framework for the study, the association of factors of these types with remaining in the CSC
program for 9 or more months was examined. Treatment retention for 9 months or more was
established as the outcome measure as this time point allowed for three completed ANSA
functional assessments by CSC providers. The research questions for the study were:

1. Do predisposing factors including the patient’s age, gender, or race/ethnicity differentially
predict treatment retention for FEP patients?

2. Do enabling factors including the type of mental health or social support services
differentially predict treatment retention for FEP patients?

3. Do need factors including the patient’s primary psychiatric diagnosis and psychotic symptom
severity differentially predict treatment retention for FEP patients?

Predisposing, enabling, and need factors identified in prior research as being associated with the
utilization of mental health services and treatment retention were included as predictors in the
multivariate analysis. In the Andersen model, predisposing (characteristics of the individual, i.e.,
age, sex, race/ethnicity), enabling (system or structural factors that make health service resources

418 The Journal of Behavioral Health Services & Research 46:3 July 2019

available to the individual), and need (clinical) factors are posited to act independently or together
to influence patterns of healthcare utilization and outcomes for individuals with SMI.32,33 The
predisposing factors examined included age,33–38 sex,36,37and racial/ethnic minority status.38–42

The enabling factors examined included CSC service components (home-based CBT, supported
employment and education, case management, and peer support).5–15 The need factors examined
included primary psychiatric diagnosis and psychotic symptom severity. 37,42–46 The conceptual
model for the study shown in Fig. 1 was adapted from prior research using the Andersen
framework. 47–50

Data analysis

Quantitative Treatment retention was examined for all continuously admitted CSC patients
between November 1, 2014, and June 30, 2016. Chi-square tests of homogeneity and independent t
tests were calculated to determine whether differences in predisposing, enabling, and need factors
between remaining in CSC treatment for 9 months or more or discontinuing treatment were
statistically significant (p G 0.05; p G 0.001) for categorical and continuous variables, respectively.
To examine the influence of the factors in the Andersen model on treatment retention, logistic
regression analysis was used for predictive modeling. Treatment retention was dichotomized as a
binary outcome variable: discontinuing treatment/remaining in treatment. Unadjusted analyses
were conducted to examine the relationship between each predictor variable and treatment
retention. To estimate the odds of treatment retention, a logistic regression model was fitted using
block-wise entry of variables. Block-wise entry of variables enabled the contribution of
predisposing, enabling, and need variables to be examined separately as blocks as done in prior
research using the Andersen model to examine psychiatric service utilization.48–50 Prior to
conducting the multivariate analysis, the appropriate diagnostic checks were completed to ensure
the model fits sufficiently well and to check for influential observations impacting the estimates of
the coefficients. Age was moderately positively skewed, and a square root transformation was
undertaken.51,52 The sample was examined for data entry mistakes and for missing data. All data
were complete and no data entry mistakes were identified; therefore, data for all 129 patients were
included in the analyses. The multivariate model was examined for multicollinearity by examining

Figure 1
Andersen Behavioral Model of Health Services Use

Retention in First Episode Psychosis Treatment HAMILTON ET AL. 419

Predisposing Factors

Need Factors

Enabling Factors

CBT
Case Management

Employment/Education
Peer Support

Age
Gender

Race/Ethnicity

Primary Diagnosis
Psychosis Symptoms

Treatment
Retention

the variance inflation factors (VIFs) for all the variables in the model. All VIFs were less than 2.0,
indicating multicollinearity did not affect the variance of the model.53 The fit of the logistic model
was examined using the Omnibus tests of model coefficients, the classification table, the Hosmer-
Lemeshow goodness-of-fit test, and the Cox/Snell and Nagelkerke pseudo r-squared (R2). Due to
the small sample size (n = 129) and the number of predictors included in the multivariate model
(n = 9), bootstrapping with random sampling with replacement was utilized to validate the model.
Bootstrapping, a Monte Carlo simulation technique, allows assigning measures of accuracy to
sample estimates.54,55

Qualitative To supplement the quantitative analysis findings, nine key informant interviews were
conducted with CSC providers who had first-hand knowledge of CSC program services and
patients. Interview participants included two CSC clinical team leads, one psychiatrist, three CSC
psychotherapists, one supported employment and education specialist, one rehab clinician, and one
peer support specialist. Grounded theory was utilized as a conceptual framework for identifying
themes and generating a theoretical explanation for treatment retention within the CSC
program.56,57 The key informant interviews were designed to obtain detailed information across
four domains including (1) CSC program characteristics and resources; (2) CSC program
implementation successes and barriers; (3) patient engagement, utilization, and medication
adherence; and (4) factors affecting patient clinical and functional outcomes. All key informant
interviews were conducted using a semi-structured interview instrument (Table 1). The key
informant interviews were conducted in person by the study principal investigator (PI). A research
assistant assisted with the key informant interviews by observing the interviews, taking notes, and
asking additional questions to ensure interview data quality. The only participant not interviewed in
person was the peer support specialist, who was on bereavement leave and participated in a
telephone interview with the PI. Prior to beginning each interview, informed consent was obtained
for each participant, who was informed that anything they said during the interview would be held
in the strictest confidence and they would not be quoted directly. Participants were told if they
chose not to participate in the interview, their decision not to participate would not be disclosed to
their employer. Participants were given the opportunity to ask any questions or voice any concerns
prior to being asked the first interview question. All interviews were recorded and transcribed. The
interview data was aggregated, and a coding rubric was developed to code interviews. Two of the
investigators (J.H. and D.W.) used an iterative, open-coding approach to identify major themes in
the key informant interview data.58 Each investigator worked independently when coding the
interview data and was blinded to the coding used by the other investigator until the coding process
was completed. The inter-coder agreement for two coders using Krippendorff’s alpha was 90% (−
0.039) for n = 40 cases (36 agreements, four disagreements).59 Disagreements in coding were
resolved through negotiated consensus, refining, and finalizing the coding structure. During the
indexing process, the coders documented how many times a particular response to an interview
question was made by an interviewee to identify themes and underlying theoretical constructs. The
final indexed text providing a listing and frequency of the codes mentioned in the interview text
(overall, within each interview, and across interviews) is presented in Table 2. Across interviews, if
a particular comment was made only once, then the comment was not included. If a response was
made by two interviewees, then it was reported as an issue raised by a few interviewees. If a
response was made by three interviewees, then it was reported as an issue raised by several
interviewees. If an issue was raised by five or more interviewees, then it was reported as an issue
raised by the majority of interviewees.60 Using grounded theory to guide the termination of the
data analysis, saturation was defined as the point at which no new codes were occurring in the
data61 and as the point at which a complete range of theoretical constructs was fully represented by
the data.62 Member checking was conducted to improve the quality of the interpretation and to

420 The Journal of Behavioral Health Services & Research 46:3 July 2019

Table 1
Semi-structured interview instrument

Domain One: CSC Program Characteristics, Resources and Services
1) What program services and/or characteristics do you think were most effective in
contributing to patient success?

2) What aspects of the program, if any, had less impact on patient success?
3) Which program resources were most helpful in achieving program success and why?
4) Were there resources you needed that weren’t available? Yes/No
5) If yes, how could we improve access to resources?
6) Do you think all the needed services were offered to patients? Yes/No
7) If not, are there any additional services that you would recommend?
Domain Two: Challenges and Benefits of Implementing the CSC
8) What are the factors that led to beneficial outcomes of the program? Please comment on
each outcome below.
a. Patient clinical improvement
b. Patient functional improvement
c. Treatment Adherence/Engagement
d. Reduced hospitalizations
e. Obtaining Employment
f. Maintaining Employment
g. Education
h. Housing
i. Primary Care Coordination
9) What were the main challenges you faced implementing CSC?
10) What resources would help in resolving challenges to implementing CSC?
11) Please describe factors that contributed to patient discontinuation of services/unplanned
discharges?

Domain Three: Patient Engagement, Utilization, and Treatment Adherence
12) Please describe how patient engagement in CSC services was successful.
13) What are ways that you would recommend to improve patient engagement?
14) What contributed to low SES scores (poor engagement) in each of the following domains:
a. Engagement
b. Collaboration
c. Help-seeking
d. Treatment adherence
15) To what extent were barriers to engagement due to each of the following and how could
they be addressed:
a. Clinical factors (e.g. clinical symptoms/cognitive functioning)
b. Social factors (e.g. poverty, unemployment, lack of other resources)
c. Program characteristics (e.g. program design)
d. System features (e.g. health insurance policy such as patients obtaining Medicaid or
commercial insurance)

16) Overall, how would you describe your patients’ consistency with attending scheduled
appointments?

17) What do you believe are the most prominent reasons for patient drop-out?
18) What services are patients missing out on upon being discharged due to enrollment in
Medicaid or commercial insurance? \

Domain Four: Factors Affecting Patient Clinical and Functional Outcomes
19) What have been challenges regarding each outcome below?

Retention in First Episode Psychosis Treatment HAMILTON ET AL. 421

validate the qualitative analysis findings.63 To protect participant confidentiality, aggregated
interview data was provided to participants for the purpose of verifying the plausibility of and for
obtaining feedback on the findings. 64,65 The researchers triangulated emerging insights with
patient interview data obtained from two semi-structured interviews conducted as part of the CSC
program evaluation.66 The major themes that emerged from the analysis of the key informant
responses are described in the BResults^ section.

Results

Sample characteristics

During the study period, 129 patients were enrolled in CSC services, and 76 (58.9%) were
retained in treatment for 9 or more months. The majority of CSC patients were male (58.9%) and
African American (53.9%). While the CSC program was developed for patients diagnosed with
emerging schizophrenia, a substantial proportion of the patients served within the CSC program
were diagnosed with major depressive disorder with psychotic features (25.6%) or bipolar
disorder with psychotic features (20.9%). While all CSC patients were followed by the CSC
psychiatrist, additional CSC services were offered to patients through a shared decision-making
process. Most patients chose to participate in case management (79.8%) and home-based CBT
(57.4%); however, less chose to participate in supported employment and education (33.3%), and
peer support services (22.5%). A full listing of sample characteristics is included in Table 3.

Statistical analysis

To test the hypothesis that predisposing, enabling, and need factors differentially predicted
treatment retention, a logistic regression model with block-wise entry was conducted. The final
adjusted analysis included all 129 continuously admitted patients. On adjusted analysis, among
predisposing factors, male gender became significantly associated with the odds of being retained
in CSC services for 9 or more months. Compared to females, males were three times more likely
to be retained in treatment (adjusted odds ratio [aOR] = 2.989, 95% confidence interval [CI] =
1.154 to 7.742, p = 0.024). Among enabling factors, participating in home-based CBT remained
significantly associated with the odds of treatment retention. Compared to patients who did not
participate in home-based CBT, patients who participated in home-based CBT were 7.3 times
more likely to be retained in treatment (aOR 7.278, CI 2.803 to 18.900, p G 0.001). The explained
variance of the total model containing all significant predictor variables by Cox/Snell and
Nagelkerke pseudo R2 was 0.293 and 0.395, respectively. The Hosmer and Lemeshow goodness-

a. Patient clinical improvement
b. Patient functional improvement
c. Treatment Adherence/Engagement
d. Reduced hospitalizations
e. Employment
f. Education
g. Housing
h. Primary Care Coordination
20) Do you have any patient stories you can share where the patient’s course of illness
worsened after being discharged from CSC due to obtaining Medicaid or commercial
insurance?

422 The Journal of Behavioral Health Services & Research 46:3 July 2019

Table 2
Listing and frequency of the codes mentioned in the interview text

Code frequency within semi-structured interview data

Code Mentioned
overall

Mentioned
within same
interview

Number of
interviews
mentioned

Multidisciplinary team approach
Multidisciplinary teamwork 26 6 7
Offering multiple layers of support
(wrap-around services)

7 2 5

Collectively reinforcing treatment
engagement and medication adherence

14 3 8

Working together to provide
educational and vocational support

10 4 5

Weekly treatment team meetings 2 – 2
Improved staff awareness of patient
clinical issues and engagement
problems

3 2 2

Emphasizing patient functioning 4 – 4
Collectively reinforcing life skills 7 – 7
Reinforcing trust and connection
between patients and other providers
(therapeutic alliance)

9 2 7

Provider flexibility
Small caseloads 3 – 3
Same-day appointments for patients
in crisis

5 2 3

Creative therapy methods to improve
engagement

8 3 5

Providing opportunities to re-engage 2 – 2
Working evening and weekend hours 4 – 4
Overwhelmed with multiple providers
and services (team-based services)

5 – 5

Taking on responsibilities beyond
traditional roles

8 2 6

Adapting the CBT curriculum
for CSC

11 3 5

Addressing patient engagement
barriers

10 2 9

Providing psychoeducation 8 4 5
Teaching life skills 7 2 6
Shared decision-making
Program philosophy 3 – 3
Patients choosing services
and providers

5 – 5

Peer support 2 – 2
Patient communication about 3 – 3

Retention in First Episode Psychosis Treatment HAMILTON ET AL. 423

of-fit test indicates a good model fit (χ2 = 7.256, degrees of freedom [df] = 8, p = 0.509). The
Omnibus test of model coefficients was highly significant, also indicating that the full model as a
whole fits significantly better than the null model and the independent variables predicted the
dependent variable well (χ2 = 44.738, df = 9, p G 0.001). The classification table was examined for
each block in the logistic regression model. The overall percentage of cases for which the
dependent variables were correctly predicted was 58.9% in the null model and 76.7% in the full
model. Both male sex (beta [β] = 1.095, CI 0.177 to 2.420, p = 0.020) and participation in home-
based CBT (β = 1.985, CI 1.098 to 3.595, p = 0.001) were significantly associated with treatment
retention in the bootstrap analysis. Thus, the significant findings for these predictor variables in
the multivariate model were validated in the bootstrap analysis. While not a significant predictor
in the multivariate analysis, African American race became a marginally significant predictor in
the bootstrap analysis (β = − 1.285, CI − 3.115 to 0.015, p = 0.047). Among predisposing,
enabling, and need factors, in the adjusted analysis, the largest change in pseudo R2 occurred with
the addition of the second block of enabling factors (R2 increase = 0.312) followed by the first
block of predisposing factors (R2 increase = 0.054). The smallest change in pseudo R2 occurred
with the addition of the third block of need factors (R2 increase = 0.029). A full listing of the
results of the unadjusted, adjusted, and bootstrap analyses is presented in Table 4.

Table 2
(continued)

Code frequency within semi-structured interview data

Code Mentioned
overall

Mentioned
within same
interview

Number of
interviews
mentioned

values and preferences
Patient-centered and individualized
(meeting patients where they
are at)

12 3 3

Readiness for program participation 7 5 4
Patient engagement barriers
Negative symptoms of psychosis 4 2 3
Prior trauma 3 – 3
Stigma 4 – 4
Lacking insight 7 2 5
Substance use 12 5 6
Criminal justice issues 2 – 2
Low intellectual functioning 3 – 3
Family conflict and lack of support 13 3 4
Limited social support 17 4 4
Poverty/lack of basic resources 9 2 7
Change in insurance status 15 14 6
Change in employment status 3 2 2
Housing instability/homelessness 6 5 5
Medication non-adherence 21 6 8

424 The Journal of Behavioral Health Services & Research 46:3 July 2019

Grounded theory

Four major themes were drawn from the key informant interviews: (1) multidisciplinary team
approach, (2) provider flexibility, (3) shared decision-making, and (4) patient engagement barriers.

Multidisciplinary Team Approach Across program services, providers reported that the
multidisciplinary team approach within CSC enabled them to offer multiple layers of support to
patients. According to a CSC provider, Bworking as a multidisciplinary team, we are able to
reinforce trust and connection between patients and other providers on the treatment team.^
Multiple providers reported using the team-based approach to address patient medication adherence
and improve functioning. A few providers identified weekly treatment team meetings as beneficial
in increasing their awareness of patient clinical issues and engagement problems. A theme emerged
among providers that the emphasis on patient functioning was a strength of the CSC program, and
through multidisciplinary teamwork, they could collectively reinforce life skills to improve patient
functioning. One patient reported that the CSC program helped her Bsee other options and gain
independence.^ Working with her CSC treatment team, she reported reaching her psychotherapy
goals to reduce hopelessness and suicidal thoughts and finding a medication regimen that worked.

Table 3
CSC sample characteristics

Characteristic Total N (%) Treatment retention
≥ 9 months N (%)

Chi-square (df) p value

Sex 3.612 (1) 0.057
Male 76 (58.9) 50 (65.8)
Female 53 (41.1) 26 (49.1)
Age (years) – 0.922
Age mean (SD) 23.14 (3.35) 23.12 (3.32) –
Race/ethnicity 7.52

Literature Review

Vol:.(1234567890)

Journal of Autism and Developmental Disorders (2019) 49:1912–1927
https://doi.org/10.1007/s10803-018-3861-x

1 3

O R I G I N A L PA P E R

A Randomised Controlled Feasibility Trial of Immersive Virtual Reality
Treatment with Cognitive Behaviour Therapy for Specific Phobias
in Young People with Autism Spectrum Disorder

Morag Maskey1 · Jacqui Rodgers1 · Victoria Grahame2,6 · Magdalena Glod1 · Emma Honey2 · Julia Kinnear3 ·
Marie Labus4 · Jenny Milne5 · Dimitrios Minos6 · Helen McConachie6 · Jeremy R. Parr1,2

Published online: 15 February 2019
© The Author(s) 2019

Abstract
We examined the feasibility and acceptability of using an immersive virtual reality environment (VRE) alongside cogni-
tive behaviour therapy (CBT) for young people with autism experiencing specific phobia. Thirty-two participants were
randomised to treatment or control. Treatment involved one session introducing CBT techniques and four VRE sessions,
delivered by local clinical therapists. Change in target behaviour was independently rated. Two weeks after treatment, four
treatment participants (25%) and no control participants were responders; at 6 months after treatment, six (38%) treatment
and no control participants were responders. At 6 months post-treatment, symptoms had worsened for one treatment and five
control (untreated) participants. Brief VRE exposure with CBT is feasible and acceptable to deliver through child clinical
services and is effective for some participants.

Keywords Autism · Anxiety · Phobia · Fear · Virtual reality · Cognitive behaviour therapy

Introduction

Autism spectrum disorder (ASD) occurs in around 1% of
the population and is characterised by social communication
difficulties and repetitive behaviours (American Psychiatric
Association 2013; Baird et al. 2006). Co-existing conditions
are common in ASD (Maskey et al. 2013) including anxiety,
which affects around half of children (Simonoff et al. 2008;

Maskey et al. 2013). In a clinical setting, anxiety is among
the most common treatment referral reasons for young peo-
ple with ASD (Ghaziuddin et  al. 2002). Specific phobia
(defined by DSM-5 as extreme or irrational fear of an object/
situation) is one of the most common anxiety presentations
in ASD (Leyfer et al. 2006; Mattila et al. 2010). Prevalence
rates of 30–64% have been reported (Leyfer et al. 2006; van
Steensel et al. 2011); rates are 5–18% in typically develop-
ing children (Ollendick et al. 2002). The nature of phobias
for children with ASD may be ‘unusual’ or atypical, such
as situation-specific fear (e.g. visiting a particular location),
of everyday objects (toilets, machines, foods), or of people
with certain personal characteristics (Mayes et al. 2013).
Importantly these difficulties have an impact on the daily
lives of the child and family, interfering with education and
learning (Maskey et al. 2014) and have been associated with
higher levels of challenging behaviours (Evans et al. 2005).

There are a range of treatments for phobias in typically
developing individuals, with cognitive behaviour therapy
(CBT) and graded exposure as key therapeutic techniques
(Ollendick et al. 2006). However, these techniques may not
be as effective for some children with ASD. For example,
graded exposure typically begins with imaginal desensiti-
sation; many individuals with ASD experience difficulties

* Jeremy R. Parr
jeremy.parr@ncl.ac.uk

1 Institute of Neuroscience, Sir James Spence Institute
Level 3, Royal Victoria Infirmary, Newcastle University,
Newcastle upon Tyne NE1 4LP, UK

2 Complex Neurodevelopmental Disorders Service,
Northumberland Tyne and Wear NHS Foundation Trust,
Newcastle upon Tyne, UK

3 Newcastle University, Newcastle upon Tyne, UK
4 Business Development and Enterprise, Faculty of Medical

Sciences, Newcastle University, Newcastle upon Tyne, UK
5 Tees Esk and Wear Valley NHS Foundation, Trust, UK
6 Institute of Health and Society, Newcastle University,

Newcastle upon Tyne, UK

1913Journal of Autism and Developmental Disorders (2019) 49:1912–1927

1 3

with imagination (Lind et al. 2014) such as producing and
controlling imaginal scenes. This may be a challenge or bar-
rier to treatment adherence and/or effectiveness. National
Institute for Health and Care Excellence (NICE) ASD man-
agement guidance in the UK specifies that CBT will require
adaptation to increase the likelihood of effectiveness for
individuals with ASD (NICE 2013). Suggested adaptations
include the development of disorder-specific hierarchies,
the use of more concrete visual tactics, incorporation of a
child’s specific interests, and inclusion of parents in treat-
ment (Moree and Davis 2010); additional adaptations may
include psychoeducation about recognising and understand-
ing emotions, problem solving, and a reduced cognitive
component with greater use of behavioural strategies such
as exposure and relaxation. Research indicates that with such
adaptations, CBT based interventions can be successful in
promoting anxiety reduction for individuals on the autism
spectrum (Lang et al. 2010; Ung et al. 2015).

Increasingly, new technologies, such as virtual reality
(VR), are being used with the neurotypical population to
augment traditional psychological treatments (Hollis et al.
2016; Freeman et al. 2017; Valmaggia et al. 2016). VR may
be particularly helpful for the delivery of interventions for
those with ASD because it allows simulations of real world
situations to be created, and newly learned coping skills
can be rehearsed and reinforced in a safe and controlled
environment (Parsons and Cobb 2011). VR has been used
successfully to improve various skills, for example, social
understanding (Mitchell et al. 2007; Kandalaft et al. 2013),
job interview skills (Smith et al. 2014), driving skills (Bian
et al. 2013) and road safety and fire alarm procedures (Jos-
man et al. 2008; Strickland et al. 2007). For people with
ASD and specific phobias, VR may offer an alternative to
usual exposure hierarchies used in traditional CBT, which
typically move through imaginal desensitisation to real life
exposure. VR may facilitate a more gradual exposure to the
feared stimulus in a controlled manner, whilst concurrently
allowing the participant to be supported to develop anxiety
management strategies with a therapist.

Given the potential utility of the combination of CBT
and VR to the treatment of specific phobias for people with
ASD, we aimed to investigate the combination of an immer-
sive virtual reality environment (VRE) alongside therapist-
delivered CBT to reduce anxiety. Maskey et.al. (2014), using
a case study design with nine volunteer children who expe-
rienced specific phobias, reported the preliminary accept-
ability of an immersive VRE, known as the Blue Room,
alongside CBT. The Blue Room is a fully immersive VRE
without the need for a headset or goggles; the therapist
controls the perceived movement through the scene with
an iPad. Each child received four VRE twenty-minute treat-
ment sessions delivered over one week. Of nine volunteer
children, eight children improved in their ability to tackle

their real life specific phobia, as described in vignettes of
behaviour and rated by an expert panel. These improvements
were maintained at 12 months follow up. The specific pho-
bias addressed were related to everyday occurrences, such
as travelling on public transport, and therefore overcoming
these phobias significantly improved families’ daily lives
(Maskey et al. 2014). Limitations included recruitment from
a community based group rather than from clinical health
services, lack of randomisation and a control group, and
treatment delivery by the study team rather than within fami-
lies’ local health services.

In order to provide further evidence, we aimed to trial the
VRE and CBT intervention reported in Maskey et al (2014)
with a larger sample of children who were being seen in
clinical services, randomising them to either a treatment or
control group (delayed treatment). We report the results of
the first Randomised Controlled Trial (RCT) of the Blue
Room VRE intervention. The study aims were to (1) evalu-
ate treatment delivery feasibility, with fidelity, by thera-
pists from two UK National Health Service (NHS) teams;
(2) determine acceptability of outcome measures to young
people and parents; (3) investigate responses to the VRE
treatment; (4) monitor whether initial benefits from treat-
ment persisted.

Methods

Study Design

This was a single blind RCT comparing a virtual reality
treatment for specific phobias in children with ASD with
usual care (immediate and control (delayed) treatment arms).
After consent and baseline measures were taken, participants
were randomised to one of these arms.

The immediate treatment group were followed up at 2
weeks and 6 months after treatment. The control arm com-
pleted outcome measures at these time points. The control
group then received the treatment after completing the meas-
ures at 6 months (see Consort Diagram); after their treat-
ment they were subsequently followed-up at 2 weeks and
6 months post treatment. The immediate treatment group
had one additional follow-up at 12 months post treatment.

Participants and Recruitment

Thirty-two young people with ASD were recruited over a 12
month period from two UK mental health services—North-
umberland, Tyne and Wear NHS Foundation Trust and Tees,
Esk and Wear Valley NHS Foundation Trust.

Inclusion criteria: Age 8–14 years, diagnosis of ASD,
verbally fluent and able to understand instructions to enable

1914 Journal of Autism and Developmental Disorders (2019) 49:1912–1927

1 3

treatment participation and completion of outcome meas-
ures. Verbal fluency and comprehension were determined as
part of usual clinical practice by the child’s clinical consult-
ant, who judged the child’s suitability for the study. All par-
ticipants had a specific phobia as identified during the Anxi-
ety Diagnostic Interview Schedule (ADIS) interview (see
below). Exclusion criteria were participants whose phobia
could not be visually represented and addressed in the Blue
Room (e.g. phobia of injections), children with severe and
complex anxiety disorder, and/or children with a learning
disability that the referring mental health clinician judged
would affect their ability to participate.

The child’s usual mental health clinician initially dis-
cussed the study with the family and then completed
an expression of interest form and the Children’s Global
Assessment Scale score (CGAS—a brief measure of emo-
tional and behavioural functioning, with range 1–100) (Shaf-
fer et al. 1983). All participants had a confirmed ASD diag-
nosis according to DSM-IV or ICD-10 criteria from NHS
multidisciplinary diagnostic teams.

On receiving the Expression of Interest form, a member
of the research team contacted families to evaluate whether
their specific phobia was suitable for treatment and for com-
puter generated, graded scene design. Forty families were
identified by clinicians; five of these did not have a phobia
that could be treated in the Blue Room and three declined
to take part after receiving further information. Thirty-two
families received a preparatory home visit where baseline
measures were completed and the family shown a video
of the Blue Room VRE; written informed consent was
obtained. Table 1 shows the characteristics of participants.
The two groups were well matched for mean age and gender
and on outcomes captured by the standardised measures.
Table 2 shows the specific phobias that were identified by
participants and their families as the target to address during
the Blue Room treatment.

Measures

Baseline Characterisation

The following measures were completed by the participant
and their parent/caregiver at baseline.

Social Communication Questionnaire (SCQ) (Berument
et  al. 1999) A parent-completed 40 item questionnaire to
describe the child’s ASD characteristics. It is used interna-
tionally, and has high sensitivity and specificity for an ASD
diagnosis.

Anxiety Disorders Interview Schedule (ADIS) (Silverman
1996) A widely used standardised clinical interview carried
out with parents; each anxiety area is given a severity rating,

including separation anxiety, social anxiety disorder, spe-
cific phobia, panic disorder, obsessive–compulsive disorder
and generalised anxiety disorder.

Vineland Adaptive Behaviour Scales (VABS) (Sparrow et  al.
2005) This parent interview allows children’s functional
abilities to be compared to age norms (Communication,
Socialisation and Daily Living Skills). We did not undertake
IQ assessment as feasibility must relate to current clinical
practice, where clinicians take pragmatic decisions about
treatment and children’s capabilities rather than basing
treatment access on assessment scores.

Outcome Measures

Maskey et al (2014) reported that Target Behaviour ratings
are appropriate outcome measures of real life change in
behaviours of concern. This is further supported in a review
of the treatment of specific fears and phobias in children
with ASD (Lydon et al. 2015), where target behaviours were
found to be the primary outcome measure in 10 of the 16
studies reviewed. This measure was therefore included as
the main outcome measure, alongside questionnaires, to
investigate the utility of different outcome measures with
this clinical population.

For the treatment and control groups the following out-
come measures were collected:

Target Behaviour rating This measure recorded a rat-
ing of change over time in the specific phobia to be tackled
through Blue Room treatment. The protocol was developed
by the Research Units on Paediatric Psychopharmacology
(RUPP) Autism Network (Arnold et al. 2003). Questions
regarding the child’s specific phobia behaviours, and ques-
tions such as ‘how often?’ and ‘how distressed?’ were asked
in a standard format to the parent, enabling a vignette to
be written. Following an interview about phobia during
the initial home visit, pre-treatment vignettes were writ-
ten prior to randomisation, by the first author (for examples
see Table 5). These baseline vignettes are not rated per se,
but rather serve as a baseline from which Target Behav-
iour change is measured. Follow-up vignettes were written
from telephone interviews with parents, undertaken by the
blinded outcome assessor. All efforts were made to maintain
the assessor as blinded. Each vignette pair (baseline vs post
treatment vignettes) was evaluated for change over time on
a 9 point scale (from ‘normalised’ to ‘disastrously worse’).
An expert panel of raters received training with examples,
before rating the pairs of vignettes. Raters were blind to
group allocation and time point, and each vignette pair was
rated by four different raters. Arnold and colleagues (Arnold
et al. 2003) reported an Intraclass Correlation Coefficient
(ICC) of 0.895 for a panel of 5 experts; in this study ICCs
for the two time points were 0.869 (95% CI 0.775 to 0.930)

1915Journal of Autism and Developmental Disorders (2019) 49:1912–1927

1 3

and 0.935 (95% CI 0.887 to 0.965). The Target Behaviour
rating is reported both dimensionally, and also by categori-
cal cut-score using a mean of 3.0 or less, corresponding to
a rating of ‘definitely improved’ or better, to define positive
treatment response (‘responders’). In addition, a cut-score

of 6.0 or more was used in this study to define those whose
symptoms had worsened compared to baseline.

Spence Children’s Anxiety Scale-parent version (SCAS-
P) and child version (SCAS-C) The SCAS (Spence 1998)
was developed to assess anxiety symptoms in children in

Table 1 Baseline characteristics
of the immediate treatment and
control groups

a SCQ Social Communication Questionnaire
b CGAS Children’s Global Assessment Scale
c ADIS Anxiety Disorders Interview Schedule

Immediate treatment
N (%)

Control group
N (%)

All children
N (%)

Gender
 Male 13 (81.3) 12 (75) 25 (78.1)
 Female 3 (18.8) 4 (25) 7 (21.9)

Age
 Mean (months) 130.13 (28.38) 129.00 (21.51) 129.56 (24.78)
 Range (months) 89–174 90–157 89–174

Ethnicity
 White 16 (100) 14 (87.5) 30 (93.8)
 Non white 2 (12.5) 2 (6.2)

Additional diagnoses
 Any 13 (81.3) 11 (68.8) 24 (67)
 Dyslexia 1 (6.3) 1 (6.3) 2 (6.3)
 Dyspraxia 3 (18.8) 4 (25.0) 7 (21.9)
 ADHD 4 (25.0) 4 (25.0) 8 (25.0)
 Other 5 (31.3) 2 (12.5) 7 (21.9)

Household income
 Above UK mean income 9 (56.3) 9 (56.3) 18 (56.3)
 Below UK mean income 6 (37.5) 7 (43.8) 13 (40.6)
 Prefer not to say 1 (6.3) 0 1 (3.1)

Information about parent who observed treatment
 Mother/Father (includes one grand-

mother)
15/1 (93.8/6.3) 14/2 (87.5/12.5) 29/3 (90.6/9.4)

 Married/cohabiting 12 (75.0) 13 (81.3) 25 (78.1)
 University degree 6 (37.5) 3 (18.8) 9 (28.1)
 Employed 10 (62.5) 9 (56.3) 19 (59.4)

SCQa score ≥ 15/<15 14/1 14/2 29/3
Mean SCQ score (SD) 25.07 (7.69)

(1 missing)
25.06 (7.59) 25.06 (7.51)

(1 missing)
Mean CGASb score (SD) 52 (13.7)

(9 participants)
49 (7.7)
(7 participants)

50.81 (11.26)
(16 participants)

ADISc primary diagnosis
 Specific phobia 14 (87.5) 14 (87.5) 28 (87.5)
 Social phobia 2 (12.5) 2 (12.5) 4 (12.5)
 Number with secondary diagnoses

(mean number of secondary diagnoses
per child)

14 (2.8) 14 (2.8) 28 (2.8)

 Mean Vineland scores (n = 14) (n = 16) (n = 30)
 Communication 73.50 (16.09) 73.63 (11.91) 73.57 (13.76)
 Daily living skills 72.07 (13.68) 65.44 (8.10) 68.57 (11.33)
 Socialisation 63.14 (10.38) 65.00 (14.97) 64.40 (12.27)
 Adaptive behaviour composite 68.43 (11.99) 66.63 (8.53) 67.53 (10.08)

1916 Journal of Autism and Developmental Disorders (2019) 49:1912–1927

1 3

the general population and has 38 items with a 0 (never)
to 3 (always) scale. The measure has been widely used in
ASD studies (Sofronoff et al. 2005; Maskey et al. 2014).
High internal consistency for the total scale score has been
reported (Spence 1998), and both convergent and divergent
validity (Nauta et al. 2004). In the current study, internal
consistency at baseline was α = 0.900 for SCAS-P and
α = 0.863 for SCAS-C.

Fear survey schedule for children—revised (FSSC-R)
(Ollendick 1983) This is an 80 item parent-report question-
naire with an overall intensity and fearfulness score. The
FSSC-R is the most commonly used tool for assessment of
common fears and phobias, with good construct, conver-
gent and divergent validity (Gullone et al. 2000) and strong
test–retest reliability and internal consistency (Burnham and
Gullone 1997). In the current study, internal consistency at
baseline was α = 0.932.

Children’s Assessment of Participation and Enjoyment
(CAPE). This was completed by the child at baseline and 9
months and intended to measure any increase in participa-
tion in community activities. CAPE is a 50 item child-report
of activities, presented pictorially, to assess children’s partic-
ipation in a range of solitary and group voluntary activities.
Reliability and validity of the CAPE was established through
study of 427 children with disabilities (King et al. 2007).

Process Measures

Attendance: whether children attended all sessions was
recorded.

Confidence ratings: during treatment children rated their
confidence at tackling their goal situation at the beginning of

session one, end of session two, beginning of session three
and end of session four. Parents rated their perception of
their child’s confidence at parallel time points. Ratings were
from 0 (not comfortable) to 6 (very comfortable); parent and
child ratings were taken in separate rooms and not shared.
Examples of a confidence scale used are given in a previous
publication (Maskey et al. 2014).

When families were approached but chose not to partici-
pate, ethical permission was granted to pass the following
anonymised data to the research team: CGAS score, age,
gender, ASD diagnosis and type of diagnosis. This was to
allow ‘refusers’ to be characterised and compared with trial
participants.

Randomisation and Masking

Participants were randomly allocated to immediate treatment
group (n = 16) or control group, for whom treatment was
offered after the 6 months outcome measures were admin-
istered (n = 16). Allocation was by computer using a pass-
word-protected Newcastle University Clinical Trials Unit
website. Randomisation was by mixed block design, using
block sizes of two and four, stratified by site. Due to the
nature of the treatment, participants, clinicians and the main
researcher for the study were aware of group allocation.
Participants were randomised and informed after the initial
home visit as to whether or not they were in the immediate
treatment group. Another researcher, blind to treatment allo-
cation, conducted outcome measurements through telephone
discussion of target behaviours with families and receiving
postal questionnaires. Blinding was strictly maintained; this
outcome assessor had no other trial role, no access to docu-
ments and did not attend trial meetings. At each telephone
or postal contact, this outcome assessor reminded parents
she was unaware of group allocation.

Materials

The Blue Room VRE is a patented immersive technology
using interactive computer generated audio visual images
projected onto the walls and ceilings of a 360 degree
screened room (Fig. 1). The room was 4 m3 and the partici-
pant and therapist sit side by side. A therapist remains with
the participant throughout the treatment sessions, deliver-
ing the CBT techniques (described below). Scenes are indi-
vidualised, incorporating an exposure hierarchy related to
the feared stimulus. For example, for dog phobia, adaptions
include the dog’s size, whether on or off a lead, barking,
and proximity to the participant. This gradation allows the
participant to experience levels of mastery in managing their
anxiety and to repeatedly practice this at one level of chal-
lenge before moving to the next (Maskey et al. 2014). The

Table 2 Specific phobias which were addressed (treatment group and
control group)

a Anxiety related to very specific social situations that were identified
by the child and their parents as highly desirable treatment targets

Treatment group phobias Control group phobias

Bananas Dogs (x2)
Wasps/bees (x2) Flying (x2)
Open spaces Wasps/bees
Dogs (x3) Specific chronological time
Lifts Heights/glass elevators (x2)
Fear of the dark Thunder and lightening
Insects Making requestsa

Being looked ata Mascots
Changes in weather Automated toys
Eating in front of other peoplea Fear of the dark
Balloons Travelling in the car
Dolls Toilets
Bats Balloons

1917Journal of Autism and Developmental Disorders (2019) 49:1912–1927

1 3

following link shows a session in progress: https ://www.
youtu be.com/watch ?v=9U-rRC8j c28.

Treatment

Before VR sessions, each participant and parent attended
a 45  minutes session with their allocated therapist. The
therapist was a health professional (for example an assis-
tant psychologist, or a specialist nurse) with experience in
ASD and/or CBT, who had attended the training workshop
(see below). Simplified CBT techniques were introduced,
including: (1) identifying feelings (how different parts of
the body feel; how thoughts, emotions and behaviours are
connected); (2) the concept of a visual ‘feeling thermom-
eter’ using the participant’s words to describe anxiety; (3)
two relaxation exercises (muscle relaxation and deep breath-
ing, with scripts for home practice); (4) identification of the
participant’s positive coping statement, e.g. ‘I can do this’,
‘I’m going to be ok’, to use in the treatment sessions. These
CBT elements were repeated and consolidated during VRE
sessions. The goal for the end of treatment was agreed with
the participant; this goal was used for the confidence rating
charts for parent and participant.

Following scene creation, participants attended 20 min
treatment sessions. Two Blue Room treatment sessions were
completed at one visit, with a fifteen minute break between.
The second two sessions were conducted around one week
later. The therapist allocated to the participant was present
during all sessions. Parents watched treatment via a video

link, and the session content and purpose of activities was
explained. For the first two sessions, a supervising qualified
clinical psychologist attended to observe and give feedback
to the therapist. This supervising therapist also answered any
questions the family had during the session.

Materials for the treatment sessions (the treatment man-
ual, customised visual scales and relaxation scripts) were
provided to therapists. Each Blue Room session started
with a relaxation scene, allowing the participants to become
familiar with the environment, and to practice relaxation
techniques and coping self-statements. The two available
relaxation scenes were of swimming dolphins, and a field
in the country; scenes had soft background music that could
be turned off if requested. The duration the child spent
looking at these scenes and practising relaxation exercises
was at the discretion of the therapist, as the aim was to be
responsive to the needs of individual participants; for most
participants, one cycle of muscle relaxation and breathing
exercises was sufficient at the beginning of each session.
The relaxation scenes were returned to during a session if
the therapist thought the participant’s anxiety was severe
or if the participant was finding it difficult to manage their
anxiety during a particular scene.

Following the relaxation scenes, the participant was intro-
duced to the VRE scene designed for them. The initial scene
was designed to be the lowest level of the exposure hierarchy
for that participant (e.g. a quiet dog on a lead in the dis-
tance). The participant gradually moved through the hierar-
chy; they progressed to an increased level of challenge when

Fig. 1 Picture of the Blue Room virtual reality environment

1918 Journal of Autism and Developmental Disorders (2019) 49:1912–1927

1 3

they were consistently reporting low levels of anxiety (score
of 2 or less on a six point scale) on the visual scale for a
scene, and there was agreement between the participant and
therapist to move on. At each level of the hierarchy, partici-
pants were supported by the therapist to practise techniques
to reduce anxiety, including relaxation exercises, thought
challenging and anxiety monitoring. If anxiety increased as
the scene became more challenging, the therapist suggested
relaxation and breathing exercises, moving to the relaxation
scenes if needed. Progress through the scenes was deter-
mined by the progress participants made towards maintain-
ing low anxiety at each level and was individualised to each
participant. After completing the fourth session, the therapist
spoke with participants and their family regarding graded
real world exposure to the anxiety situation. The therapist
explained the need to gradually introduce the participant to
the feared situation in real life and discussed various steps in
the hierarchy of exposure relevant to the particular phobia.

Therapist Training and Treatment Fidelity
Measurement

Before delivering treatment, local therapists read the manual
and attended a 2 hours, group training workshop delivered
by an experienced child clinical psychologist (author 10).
The manual for the treatment is copyrighted and is available
on request from the corresponding author. Training involved
discussion of why children with ASD may develop anxi-
ety, explanation of the steps in treatment including evolu-
tion over four sessions, review of video material from live
sessions, and individual practice with the tablet computer
in the VRE.

All Blue Room treatment sessions were video recorded. A
sample of 30% of sessions in the immediate treatment group
were rated for fidelity to delivery as per the manual. The
sessions were chosen at random but always included at least
one session conducted by each of the 11 therapists, and an
even spread of VRE sessions 1 to 4. Fidelity was recorded on
a checklist to assess (a) Delivery of CBT best practice and
(b) the manual Content and Structure [checklist designed by
author 2, drawing on sources including Roth & Pilling (Roth
and Pilling 2008)]. Delivery ratings included Techniques
used (9 or 10 elements e.g. collaborative approach, mod-
elling reflection, using relaxation strategies, using praise),
Generic Acceptable components (5 elements e.g. therapeutic
alliance, managing emotional content, appropriate flexibil-
ity) and Undesirable components (6 elements e.g. didactic
approach, allows off-topic deviation); Content and Structure
included around 10 elements (e.g. setting agenda, summa-
rising, scenes presented in increasing levels of difficulty).
Rating definitions and number varied between sessions for
Techniques and Content, as different elements were intro-
duced or became irrelevant. Delivery ratings were: 0 (not at

all), 1 (minimal evidence), 2 (several examples) with ratings
reversed for Undesirable components. Content ratings were:
0 (not covered), 1 (covered insufficiently) and 2 (covered
adequately). Senior co-authors (authors 2, 3 and 10) estab-
lished mean inter-rater agreement at 83.6% for Techniques,
96.0% for Acceptable and 92.2% for Undesirable compo-
nents. Agreement of mean 69.7% (range across raters and
sessions 56–94%) for Content and Structure was lower so
was not rated further. Content rating proved difficult for sev-
eral reasons: the quality of audio in recordings; some aspects
perhaps being covered outside the VR; expectation that CBT
would be flexibly individualised.

Analysis

Analysis was conducted according to a pre-specified sta-
tistical analysis plan. Post hoc testing of the main outcome
measure found sensitive to change in our development study
(Target Behaviour rating) was then conducted to explore
potential efficacy.

Analysis was undertaken by author 4, blind to group sta-
tus and supervised by author 2.

Group equivalence at baseline was investigated using
Fisher’s exact test, Pearson’s chi square and t-tests. Explor-
atory group comparison over time was made for the Tar-
get Behaviour ratings using Mann Whitney U test and chi

Literature Review

1

Running head: LITERATURE REVIEW

6

LITERATURE REVIEW

Literature Review

Stratford University

Literature Review

This literature review will discuss and critique five articles addressing new graduate nurse retention, in relation to my research question of, “For new graduate nursing students hired into INOVA Fairfax ED, does the use of a buddy program for the first year of employment reduce the future risk of turnover compared with no post-orientation intervention?”.

Retention of new graduate nurses in all nursing specialties is imperative. Not only is it cost effective to increase the rate of retention of new graduates, the decrease in turnover will improve staffing ratios and patient outcomes. There is a need for research on post-orientation interventions such as a buddy program to decrease turnover of new graduate nurses. Building relationship between new and experienced staff members in crucial, because we are already experiencing a shortage of nurses. Therefore, we need to find a way to stop new nurses form leaving their positions within the first year, and further decrease the likelihood they will leave the profession altogether.

The first study reviewed was a phenomenological study seeking to understand the experiences of graduate nurses and their transition into professional practice (Kelly & McAllister, 2013). A two-year study in which fourteen out of sixty-five senior nursing students from an Australian university participated. The subjects varied in age and background. The preceptors had minimal training received by the hospital that would affect the reliability of this study. Data was collected through semi-structured interviews and journals kept by the participants. The data was collected and inputted into NVivo, an analysis tool, to generate themes throughout the data. There was consistency of data collection and the analysis tools used were appropriate for this study.

The size of this study was limited, which could affect generalizability of the findings. However, the details provided by the participants will aid in the understanding barriers and facilitators of quality learning through clinical preceptors (Kelly & McAllister, 2013). The information obtained through this study expresses a deep need for relationship building between the preceptor and the student to enhance the learning process and build confidence as a new nurse.

The second study, a phenomenological study, followed seven new graduate nurses. All of which varied in age, degrees (i.e. associates or bachelor’s), hospitals, and department. The inclusion criteria consisted of being a new graduate nurse and participation in a new grad residency program. Data collection was obtained through audio recorded interviews performed by the primary researcher. Each interview lasted forty-five to sixty minutes in a setting selected by the participant, which shows consistency in the collection of the data. Great consideration and rigor was taken into account concerning credibility, transferability, dependability, and confirmability of the data (Moore & Cagle, 2012). Two experienced researchers individually collectively analyzed this data to confirm emerging themes. Some limitations to this research was concerning the background and history of the participants had including prior patient care experience.

The third study reviewed was a convergent mixed methods study which was a part of a larger project. The larger project was evaluating the effectiveness of clinical supervision for new graduate nurses that were working in an acute care setting (Hussein, Everett, Ramjan, & Salamonson, 2017). The sample size was one hundred-forty new graduate nurses which were enrolled in a twelve-month long transition program at a Sydney hospital. The Manchester Clinical Supervision Scale (MCSS-26) was used to assess the new graduate nurse’s perception of the quality of clinical supervision. In addition, the Practice Environment Scale -Australia (PES-AUS) was used to assess satisfaction with the clinical environment. These tools allowed for consistency in the collection of the data. Other factors were also taken into consideration such as age, gender, and prior experience in the healthcare profession (Hussein, Everett, Ramjan, & Salamonson, 2017). The quantitative data was analyzed using a statistical software package (IBM SPSS Statistics Version 22), and “continuous variables were assessed for normality using the Kolmogorov-Smirnov test, and expressed as median and range” (Hussein, Everett, Ramjan, & Salamonson, 2017, p.4). This form of data collection and analysis was appropriate for this study, and tools have been proven to be reliable. Although there are limitations to this study, which include the study being conducted at only one facility. Additionally, the self-repot methods used for the qualitative portion of this survey were not very reliable.

The fourth study reviewed was a retrospective descriptive evaluative design, which looked at retention between two groups of graduate RNs in the critical care units of Cohen Children’s Medical Center (CCMC) before and after the initiation of the Pediatric Fellowship Program (PNFP) (Friedman, Delaney, Schmidt, Quinn, & Macyk, 2013). A nonprobability convenience sample was used for this study. The sample in this study consists of new graduate RNs hired to begin nursing orientation during March 2005 to August 2007, prior to the initiation of the PNFP, and September 2007 to March 2010, after the initiation of PNFP (Friedman, Delaney, Schmidt, Quinn, & Macyk, 2013). The collection of data regarding retention of both groups was retrieved through the CCMC’s HR department. The data for both groups was measured longitudinally at four different points after the commencement of the new graduate’s program. There was consistency in the collection of data, as well as reliability in the source of the data. The tool used to measure all data was made specifically for this study, appropriate for this data analysis. Limitations in this study are concerned with the retrospective design. Other variables that may have affected new graduate nurse retention are those that the researchers were unable to detect. There was a significant increase in the new graduate nurse retention once the PNFP was implemented (Friedman, Delaney, Schmidt, Quinn, & Macyk, 2013).

The last study which I reviewed was a qualitative study aimed to reveal the experiences and perceptions of nurses regarding turnover to identify strategies to improve retention, job satisfaction, and performance (Dawson, Stasa, Roche, Homer, & Duffield, 2014). The sample consisted of three hundred and sixty-two nurses working on a medical and surgical unit from three of Australia’s states/territories. This study was part of a larger project which examined the relationship between turnover and patient, organizational, and staff outcomes. The study distributed a survey with an open-ended question at the end, which allowed the participants to elaborate on needs and concerns of turnover. Statements were then analyzed using NVivo a qualitative data analysis tool, and themes emerged from this analysis. There was consistency in the collection of the data, and reliability of the instruments used. Out of this data three themes emerged. One which relates to the given research question about the factors that directly affect turnover. Factors listed under this theme include limited career options, poor staff support, poor recognition, and poor staff attitudes, all of which contributes to turnover. This study showed the importance of the relationships between the staff members to reduce the rate of turnover. limitations to this study such as only twenty-two percent of the sample from the larger survey answered the open question. Due to the limited response this may potentially affect the data quality, because this may not be the typical nurse’s perspective.

After reviewing the research that could be found on new graduate nurse retention and mentoring programs I have found there is little research on programs after the orientation phase of the transition from student to being in the workforce. Throughout the research there is a trend of relationship building among staff, bridging the gap between new and experienced nurses. In many of the reviewed literature during interviews, new graduates consistently expressed a lack of support, especially after the orientation phase. Moving forward research needs to be addressed to evaluate if a buddy program for new nurses is effective in increasing retention and decreasing turnover.

References

Dawson, A. J., Stasa, H., Roche, M. A., Homer, C. S. E., & Duffield, C. (2014). Nursing churn and turnover in Australian hospitals: Nurses perceptions and suggestions for supportive strategies. BMC Nursing, 13, 11. doi:http://dx.doi.org.prx-stratford.lirn.net/10.1186/1472-6955-13-11

Friedman, M. I., Delaney, M. M., Schmidt, K., Quinn, C., & Macyk, I. (2013). Specialized new graduate RN pediatric orientation: A strategy for nursing retention and its financial impact. Nursing Economics, 31(4), 162.

Hussein, R., Everett, B., Ramjan, L. M., Hu, W., & Salamonson, Y. (2017). New graduate nurses’ experiences in a clinical specialty: a follow up study of newcomer perceptions of transitional support. BMC nursing, 16(1), 42.

Kelly, J., & McAllister, M. (2013). Lessons students and new graduates could teach: a phenomenological study that reveals insights on the essence of building a supportive learning culture through preceptorship. Contemporary nurse, 44(2), 170-177.

Moore, Penny, PhD, R.N., C.N.L., & Cagle, Carolyn Spence, PhD., R.N.C. (2012). The lived experience of new nurses: Importance of the clinical preceptor. The Journal of Continuing Education in Nursing, 43(12), 555-565. doi:http://dx.doi.org.prx-stratford.lirn.net/10.3928/00220124-20120904-29

Literature Review

Treatment Retention Among Patients
Participating in Coordinated Specialty Care
for First-Episode Psychosis: a Mixed-Methods
Analysis

Jane E. Hamilton, PhD, MPH
Devika Srivastava, PhD
Danica Womack, BS
Ashlie Brown, MEd
Brian Schulz, MEd
April Macakanja, MEd
April Walker, BA
Mon-Ju Wu, PhD
Mark Williamson, MD
Raymond Y. Cho, MD, MSc

Abstract

Young adults experiencing first-episode psychosis have historically been difficult to retain in
mental health treatment. Communities across the United States are implementing Coordinated

Address correspondence to Jane E. Hamilton, PhD, MPH, Department of Psychiatry and Behavioral Sciences, McGovern
Medical School, University of Texas Health Science Center Houston, 1941 East Road, Suite 1204, Houston, TX 77054,
USA. E-mail: Jane.E.Hamilton@uth.tmc.edu.

Mon-Ju Wu, PhD, Department of Psychiatry and Behavioral Sciences, McGovern Medical School, University of Texas
Health Science Center Houston, Houston, TX, USA.

Devika Srivastava, PhD, Harris Center for Mental Health and IDD, Houston, TX, USA.
Ashlie Brown, MEd, Harris Center for Mental Health and IDD, Houston, TX, USA.
Brian Schulz, MEd, Harris Center for Mental Health and IDD, Houston, TX, USA.
April Macakanja, MEd, Harris Center for Mental Health and IDD, Houston, TX, USA.
Mark Williamson, MD, Harris Center for Mental Health and IDD, Houston, TX, USA.
Danica Womack, BS, Department of Psychiatry and Behavioral Sciences, Baylor College of Medicine, Houston, TX,

USA.
April Walker, BA, Department of Psychiatry and Behavioral Sciences, Baylor College of Medicine, Houston, TX, USA.
Raymond Y. Cho, MD, MSc, Department of Psychiatry and Behavioral Sciences, Baylor College of Medicine, Houston,

TX, USA.

Journal of Behavioral Health Services & Research, 2018. 415–433. c) 2018 National Council for Behavioral Health. DOI
10.1007/s11414-018-9619-6

Retention in First Episode Psychosis Treatment HAMILTON ET AL. 415

Specialty Care to improve outcomes for individuals experiencing first-episode psychosis. This
mixed-methods research study examined the relationship between program services and treatment
retention, operationalized as the likelihood of remaining in the program for 9 months or more. In
the adjusted analysis, male gender and participation in home-based cognitive behavioral therapy
were associated with an increased likelihood of remaining in treatment. The key informant
interview findings suggest the shared decision-making process and the breadth, flexibility, and
focus on functional recovery of the home-based cognitive behavioral therapy intervention may
have positively influenced treatment retention. These findings suggest the use of shared decision-
making and improved access to home-based cognitive behavioral therapy for first-episode
psychosis patients may improve outcomes for this vulnerable population.

Introduction

Approximately 100,000 adolescents and young adults in the United States (U.S.) experience
first-episode psychosis (FEP) each year.1,2 Early intervention with evidence-based treatment is
recommended for clinical and functional recovery for individuals with FEP.3,4 Research supports
the effectiveness of FEP interventions that include low doses of atypical antipsychotic
medications,5,6 cognitive behavioral therapy (CBT),7–10 family education and support,11–13 and
supported employment and education.14,15 Two elements of early intervention in FEP that are
distinct from standard mental health care include early detection and phase-specific treatment.16

The implementation of effective early interventions for FEP can potentially improve patient
outcomes and reduce the burden of illness associated with psychotic disorders. Coordinated
Specialty Care (CSC) is a recovery-oriented treatment program for individuals experiencing FEP.1

Young adults experiencing FEP have historically been difficult to engage and retain in ongoing
mental health treatment.17 Approximately one third of young adults experiencing FEP delay
treatment for 1 to 3 years.18 Once in treatment, the majority of FEP patients drop out within the
first year of care.18 Causes for this alarmingly high rate of early disengagement from treatment
include poor therapeutic alliance, mistrust of the system, and poor insight into the need for
treatment.17 Treatment disengagement has been shown to result in poor clinical outcomes including
symptom relapse and psychiatric hospitalization.17 Thus, FEP interventions seeking to improve
treatment engagement and retention have the potential to improve clinical outcomes for this
vulnerable group. Research suggests that specialized FEP programs are more successful in
engaging young people in mental health services compared to routine care.19 Additionally, FEP
patients participating in specialized FEP clinics remain in treatment longer compared to those in
standard community clinics.20 To engage and retain FEP patients in treatment, CSC utilizes a team-
based approach and offers a continuum of evidence-based services within a framework of
collaborative treatment planning21 and shared decision-making.1,22 The CSC program aims to
personalize treatment for patients to meet recovery-oriented goals focused on developmental
milestones.1

In 2015, a CSC pilot program was implemented at a community mental health clinic in a large
urban area. An evaluation of the pilot program found that the majority of patients who participated
in the CSC pilot project (n = 129) were retained in mental health treatment for 9 months or more,
compared to 72 days on average for patients participating in standard treatment at another safety-
net clinic within the same mental health system. Compared to the continuum of services CSC
patients participated in, standard treatment patients only participated in psychiatric medication
management and case management services. To compare treatment lengths of stay, treatment as
usual patients were randomly identified from a clinic sample (n = 1503 eligible controls) and
matched with CSC patients for age, gender, and psychotic symptom severity. Because the
relationship between CSC service participation and treatment retention remains underexplored, the

416 The Journal of Behavioral Health Services & Research 46:3 July 2019

current study expands upon prior research by examining treatment retention operationalized as the
likelihood of remaining in the CSC program for 9 months or more.

Methods

Study design

This mixed-methods study examined utilization data for continuously admitted CSC patients and
interview data from interviews conducted with CSC providers after the program was fully
implemented. This study was approved by the University of Texas Health Science Center Houston
Institutional Review Board (IRB) by expedited review and approval.

Setting and population

The study data were obtained as part of the program evaluation of the CSC program
implemented at a safety-net psychiatric outpatient clinic in a large urban area. The following
eligibility criteria were established for participation in the CSC program:

� Received a qualifying diagnosis (or initiated psychiatric treatment) for a psychotic disorder
within the previous 2 years: schizophrenia spectrum diagnosis, major depressive disorder with
psychotic features, or bipolar disorder with psychotic features;

� Be between the ages of 15–30;
� Be uninsured (cannot be enrolled in Medicaid or commercial insurance); and
� Agree to participate in 7 h per month of CSC services.

Coordinated Specialty Care

The CSC program in the current study was implemented as a comprehensive wrap-around
program designed to meet the individualized needs of patients experiencing FEP. 23 The program
incorporated the core concepts of the Prevention and Recovery in Early Psychosis (PREP(®)
program including a focus on early, evidence-based, person-centered, phase-specific, integrated,
continuous, and comprehensive care).24 Clinic-based CSC services included pharmacotherapy with
a psychiatrist trained in FEP treatment. Home-based services included CBT, supported employment
and education, case management, and peer support.

Pharmacotherapy Each patient enrolled in the CSC pilot program was followed by a psychiatrist
specializing in early psychosis recovery. Pharmacotherapy included the use of lower medication
dosages, establishment of medication adherence practices, monitoring for evolving or changing
psychopathology, emphasis on patient functioning, development of healthy lifestyle habits, and
ensuring optimal metabolic and cardiovascular health through regular primary care services in
coordination with the patient’s psychiatric care.25 Shared decision-making was used to guide
interactions between the CSC psychiatrist and patient.26

Home-Based Cognitive Behavioral Therapy Home-based CBT was delivered by a licensed
master’s level psychotherapist with current Texas certification in CBT. The CBT intervention
provided within the CSC program targeted the following domains: illness management, medication
adherence, residual symptoms, trauma, substance use, life skills, and social/occupational/
educational functioning.

Retention in First Episode Psychosis Treatment HAMILTON ET AL. 417

Supported Employment and Education Home-based supported employment and education
services were delivered by an employment and education specialist utilizing a manualized
intervention to assist patients with reentering the workforce or enrolling in school.

Case Management Home-based case management services were provided by a rehabilitation
clinician who assisted patients in accessing community resources and supports and to navigate the
criminal justice system. Specific linkages to medical and social services included primary care
coordination, food stamp application assistance, and housing program application assistance.

Peer Support A FEP-trained peer support specialist participated as a CSC team member and
provided ongoing support to CSC patients. Using shared decision-making, peer specialists worked
with CSC patients to identify treatment options and to explore treatment preferences.

Patient Assessments Each CSC patient was assessed at program admission and every 90 days
during treatment by a CSC clinician who completed a functional assessment, the Adult Needs and
Strengths Assessment (ANSA).27,28 As part of the ANSA, patient functional improvement and the
severity of each patient’s psychosis/thought disturbance were assessed by a psychotherapist for
each CSC patient to plan for ongoing behavioral health needs. To tailor CBT interventions, two
validated measures of psychotic symptoms, the Positive and Negative Syndrome Scale (PANSS)29

and the Brief Psychiatric Rating Scale (BPRS),30 were administered at intake and after 9 months of
service participation. To improve program implementation fidelity, the study investigators
conducted ten onsite PANSS and BPRS assessment trainings with the psychotherapists from
June 2015 through January 2016. Inter-rater reliability was established during four trainings and
ranged from 70 to 85%.

Study protocol, measurements, and outcome measures

To systematically examine predictors of treatment retention for CSC patients, Andersen’s
Behavioral Model of Health Services Use was used to select study variables and to organize the
study findings. The Andersen model conceptual framework includes factors shown in a number of
studies to explain variation in health service use among vulnerable populations.31,32 In adapting the
framework for the study, the association of factors of these types with remaining in the CSC
program for 9 or more months was examined. Treatment retention for 9 months or more was
established as the outcome measure as this time point allowed for three completed ANSA
functional assessments by CSC providers. The research questions for the study were:

1. Do predisposing factors including the patient’s age, gender, or race/ethnicity differentially
predict treatment retention for FEP patients?

2. Do enabling factors including the type of mental health or social support services
differentially predict treatment retention for FEP patients?

3. Do need factors including the patient’s primary psychiatric diagnosis and psychotic symptom
severity differentially predict treatment retention for FEP patients?

Predisposing, enabling, and need factors identified in prior research as being associated with the
utilization of mental health services and treatment retention were included as predictors in the
multivariate analysis. In the Andersen model, predisposing (characteristics of the individual, i.e.,
age, sex, race/ethnicity), enabling (system or structural factors that make health service resources

418 The Journal of Behavioral Health Services & Research 46:3 July 2019

available to the individual), and need (clinical) factors are posited to act independently or together
to influence patterns of healthcare utilization and outcomes for individuals with SMI.32,33 The
predisposing factors examined included age,33–38 sex,36,37and racial/ethnic minority status.38–42

The enabling factors examined included CSC service components (home-based CBT, supported
employment and education, case management, and peer support).5–15 The need factors examined
included primary psychiatric diagnosis and psychotic symptom severity. 37,42–46 The conceptual
model for the study shown in Fig. 1 was adapted from prior research using the Andersen
framework. 47–50

Data analysis

Quantitative Treatment retention was examined for all continuously admitted CSC patients
between November 1, 2014, and June 30, 2016. Chi-square tests of homogeneity and independent t
tests were calculated to determine whether differences in predisposing, enabling, and need factors
between remaining in CSC treatment for 9 months or more or discontinuing treatment were
statistically significant (p G 0.05; p G 0.001) for categorical and continuous variables, respectively.
To examine the influence of the factors in the Andersen model on treatment retention, logistic
regression analysis was used for predictive modeling. Treatment retention was dichotomized as a
binary outcome variable: discontinuing treatment/remaining in treatment. Unadjusted analyses
were conducted to examine the relationship between each predictor variable and treatment
retention. To estimate the odds of treatment retention, a logistic regression model was fitted using
block-wise entry of variables. Block-wise entry of variables enabled the contribution of
predisposing, enabling, and need variables to be examined separately as blocks as done in prior
research using the Andersen model to examine psychiatric service utilization.48–50 Prior to
conducting the multivariate analysis, the appropriate diagnostic checks were completed to ensure
the model fits sufficiently well and to check for influential observations impacting the estimates of
the coefficients. Age was moderately positively skewed, and a square root transformation was
undertaken.51,52 The sample was examined for data entry mistakes and for missing data. All data
were complete and no data entry mistakes were identified; therefore, data for all 129 patients were
included in the analyses. The multivariate model was examined for multicollinearity by examining

Figure 1
Andersen Behavioral Model of Health Services Use

Retention in First Episode Psychosis Treatment HAMILTON ET AL. 419

Predisposing Factors

Need Factors

Enabling Factors

CBT
Case Management

Employment/Education
Peer Support

Age
Gender

Race/Ethnicity

Primary Diagnosis
Psychosis Symptoms

Treatment
Retention

the variance inflation factors (VIFs) for all the variables in the model. All VIFs were less than 2.0,
indicating multicollinearity did not affect the variance of the model.53 The fit of the logistic model
was examined using the Omnibus tests of model coefficients, the classification table, the Hosmer-
Lemeshow goodness-of-fit test, and the Cox/Snell and Nagelkerke pseudo r-squared (R2). Due to
the small sample size (n = 129) and the number of predictors included in the multivariate model
(n = 9), bootstrapping with random sampling with replacement was utilized to validate the model.
Bootstrapping, a Monte Carlo simulation technique, allows assigning measures of accuracy to
sample estimates.54,55

Qualitative To supplement the quantitative analysis findings, nine key informant interviews were
conducted with CSC providers who had first-hand knowledge of CSC program services and
patients. Interview participants included two CSC clinical team leads, one psychiatrist, three CSC
psychotherapists, one supported employment and education specialist, one rehab clinician, and one
peer support specialist. Grounded theory was utilized as a conceptual framework for identifying
themes and generating a theoretical explanation for treatment retention within the CSC
program.56,57 The key informant interviews were designed to obtain detailed information across
four domains including (1) CSC program characteristics and resources; (2) CSC program
implementation successes and barriers; (3) patient engagement, utilization, and medication
adherence; and (4) factors affecting patient clinical and functional outcomes. All key informant
interviews were conducted using a semi-structured interview instrument (Table 1). The key
informant interviews were conducted in person by the study principal investigator (PI). A research
assistant assisted with the key informant interviews by observing the interviews, taking notes, and
asking additional questions to ensure interview data quality. The only participant not interviewed in
person was the peer support specialist, who was on bereavement leave and participated in a
telephone interview with the PI. Prior to beginning each interview, informed consent was obtained
for each participant, who was informed that anything they said during the interview would be held
in the strictest confidence and they would not be quoted directly. Participants were told if they
chose not to participate in the interview, their decision not to participate would not be disclosed to
their employer. Participants were given the opportunity to ask any questions or voice any concerns
prior to being asked the first interview question. All interviews were recorded and transcribed. The
interview data was aggregated, and a coding rubric was developed to code interviews. Two of the
investigators (J.H. and D.W.) used an iterative, open-coding approach to identify major themes in
the key informant interview data.58 Each investigator worked independently when coding the
interview data and was blinded to the coding used by the other investigator until the coding process
was completed. The inter-coder agreement for two coders using Krippendorff’s alpha was 90% (−
0.039) for n = 40 cases (36 agreements, four disagreements).59 Disagreements in coding were
resolved through negotiated consensus, refining, and finalizing the coding structure. During the
indexing process, the coders documented how many times a particular response to an interview
question was made by an interviewee to identify themes and underlying theoretical constructs. The
final indexed text providing a listing and frequency of the codes mentioned in the interview text
(overall, within each interview, and across interviews) is presented in Table 2. Across interviews, if
a particular comment was made only once, then the comment was not included. If a response was
made by two interviewees, then it was reported as an issue raised by a few interviewees. If a
response was made by three interviewees, then it was reported as an issue raised by several
interviewees. If an issue was raised by five or more interviewees, then it was reported as an issue
raised by the majority of interviewees.60 Using grounded theory to guide the termination of the
data analysis, saturation was defined as the point at which no new codes were occurring in the
data61 and as the point at which a complete range of theoretical constructs was fully represented by
the data.62 Member checking was conducted to improve the quality of the interpretation and to

420 The Journal of Behavioral Health Services & Research 46:3 July 2019

Table 1
Semi-structured interview instrument

Domain One: CSC Program Characteristics, Resources and Services
1) What program services and/or characteristics do you think were most effective in
contributing to patient success?

2) What aspects of the program, if any, had less impact on patient success?
3) Which program resources were most helpful in achieving program success and why?
4) Were there resources you needed that weren’t available? Yes/No
5) If yes, how could we improve access to resources?
6) Do you think all the needed services were offered to patients? Yes/No
7) If not, are there any additional services that you would recommend?
Domain Two: Challenges and Benefits of Implementing the CSC
8) What are the factors that led to beneficial outcomes of the program? Please comment on
each outcome below.
a. Patient clinical improvement
b. Patient functional improvement
c. Treatment Adherence/Engagement
d. Reduced hospitalizations
e. Obtaining Employment
f. Maintaining Employment
g. Education
h. Housing
i. Primary Care Coordination
9) What were the main challenges you faced implementing CSC?
10) What resources would help in resolving challenges to implementing CSC?
11) Please describe factors that contributed to patient discontinuation of services/unplanned
discharges?

Domain Three: Patient Engagement, Utilization, and Treatment Adherence
12) Please describe how patient engagement in CSC services was successful.
13) What are ways that you would recommend to improve patient engagement?
14) What contributed to low SES scores (poor engagement) in each of the following domains:
a. Engagement
b. Collaboration
c. Help-seeking
d. Treatment adherence
15) To what extent were barriers to engagement due to each of the following and how could
they be addressed:
a. Clinical factors (e.g. clinical symptoms/cognitive functioning)
b. Social factors (e.g. poverty, unemployment, lack of other resources)
c. Program characteristics (e.g. program design)
d. System features (e.g. health insurance policy such as patients obtaining Medicaid or
commercial insurance)

16) Overall, how would you describe your patients’ consistency with attending scheduled
appointments?

17) What do you believe are the most prominent reasons for patient drop-out?
18) What services are patients missing out on upon being discharged due to enrollment in
Medicaid or commercial insurance? \

Domain Four: Factors Affecting Patient Clinical and Functional Outcomes
19) What have been challenges regarding each outcome below?

Retention in First Episode Psychosis Treatment HAMILTON ET AL. 421

validate the qualitative analysis findings.63 To protect participant confidentiality, aggregated
interview data was provided to participants for the purpose of verifying the plausibility of and for
obtaining feedback on the findings. 64,65 The researchers triangulated emerging insights with
patient interview data obtained from two semi-structured interviews conducted as part of the CSC
program evaluation.66 The major themes that emerged from the analysis of the key informant
responses are described in the BResults^ section.

Results

Sample characteristics

During the study period, 129 patients were enrolled in CSC services, and 76 (58.9%) were
retained in treatment for 9 or more months. The majority of CSC patients were male (58.9%) and
African American (53.9%). While the CSC program was developed for patients diagnosed with
emerging schizophrenia, a substantial proportion of the patients served within the CSC program
were diagnosed with major depressive disorder with psychotic features (25.6%) or bipolar
disorder with psychotic features (20.9%). While all CSC patients were followed by the CSC
psychiatrist, additional CSC services were offered to patients through a shared decision-making
process. Most patients chose to participate in case management (79.8%) and home-based CBT
(57.4%); however, less chose to participate in supported employment and education (33.3%), and
peer support services (22.5%). A full listing of sample characteristics is included in Table 3.

Statistical analysis

To test the hypothesis that predisposing, enabling, and need factors differentially predicted
treatment retention, a logistic regression model with block-wise entry was conducted. The final
adjusted analysis included all 129 continuously admitted patients. On adjusted analysis, among
predisposing factors, male gender became significantly associated with the odds of being retained
in CSC services for 9 or more months. Compared to females, males were three times more likely
to be retained in treatment (adjusted odds ratio [aOR] = 2.989, 95% confidence interval [CI] =
1.154 to 7.742, p = 0.024). Among enabling factors, participating in home-based CBT remained
significantly associated with the odds of treatment retention. Compared to patients who did not
participate in home-based CBT, patients who participated in home-based CBT were 7.3 times
more likely to be retained in treatment (aOR 7.278, CI 2.803 to 18.900, p G 0.001). The explained
variance of the total model containing all significant predictor variables by Cox/Snell and
Nagelkerke pseudo R2 was 0.293 and 0.395, respectively. The Hosmer and Lemeshow goodness-

a. Patient clinical improvement
b. Patient functional improvement
c. Treatment Adherence/Engagement
d. Reduced hospitalizations
e. Employment
f. Education
g. Housing
h. Primary Care Coordination
20) Do you have any patient stories you can share where the patient’s course of illness
worsened after being discharged from CSC due to obtaining Medicaid or commercial
insurance?

422 The Journal of Behavioral Health Services & Research 46:3 July 2019

Table 2
Listing and frequency of the codes mentioned in the interview text

Code frequency within semi-structured interview data

Code Mentioned
overall

Mentioned
within same
interview

Number of
interviews
mentioned

Multidisciplinary team approach
Multidisciplinary teamwork 26 6 7
Offering multiple layers of support
(wrap-around services)

7 2 5

Collectively reinforcing treatment
engagement and medication adherence

14 3 8

Working together to provide
educational and vocational support

10 4 5

Weekly treatment team meetings 2 – 2
Improved staff awareness of patient
clinical issues and engagement
problems

3 2 2

Emphasizing patient functioning 4 – 4
Collectively reinforcing life skills 7 – 7
Reinforcing trust and connection
between patients and other providers
(therapeutic alliance)

9 2 7

Provider flexibility
Small caseloads 3 – 3
Same-day appointments for patients
in crisis

5 2 3

Creative therapy methods to improve
engagement

8 3 5

Providing opportunities to re-engage 2 – 2
Working evening and weekend hours 4 – 4
Overwhelmed with multiple providers
and services (team-based services)

5 – 5

Taking on responsibilities beyond
traditional roles

8 2 6

Adapting the CBT curriculum
for CSC

11 3 5

Addressing patient engagement
barriers

10 2 9

Providing psychoeducation 8 4 5
Teaching life skills 7 2 6
Shared decision-making
Program philosophy 3 – 3
Patients choosing services
and providers

5 – 5

Peer support 2 – 2
Patient communication about 3 – 3

Retention in First Episode Psychosis Treatment HAMILTON ET AL. 423

of-fit test indicates a good model fit (χ2 = 7.256, degrees of freedom [df] = 8, p = 0.509). The
Omnibus test of model coefficients was highly significant, also indicating that the full model as a
whole fits significantly better than the null model and the independent variables predicted the
dependent variable well (χ2 = 44.738, df = 9, p G 0.001). The classification table was examined for
each block in the logistic regression model. The overall percentage of cases for which the
dependent variables were correctly predicted was 58.9% in the null model and 76.7% in the full
model. Both male sex (beta [β] = 1.095, CI 0.177 to 2.420, p = 0.020) and participation in home-
based CBT (β = 1.985, CI 1.098 to 3.595, p = 0.001) were significantly associated with treatment
retention in the bootstrap analysis. Thus, the significant findings for these predictor variables in
the multivariate model were validated in the bootstrap analysis. While not a significant predictor
in the multivariate analysis, African American race became a marginally significant predictor in
the bootstrap analysis (β = − 1.285, CI − 3.115 to 0.015, p = 0.047). Among predisposing,
enabling, and need factors, in the adjusted analysis, the largest change in pseudo R2 occurred with
the addition of the second block of enabling factors (R2 increase = 0.312) followed by the first
block of predisposing factors (R2 increase = 0.054). The smallest change in pseudo R2 occurred
with the addition of the third block of need factors (R2 increase = 0.029). A full listing of the
results of the unadjusted, adjusted, and bootstrap analyses is presented in Table 4.

Table 2
(continued)

Code frequency within semi-structured interview data

Code Mentioned
overall

Mentioned
within same
interview

Number of
interviews
mentioned

values and preferences
Patient-centered and individualized
(meeting patients where they
are at)

12 3 3

Readiness for program participation 7 5 4
Patient engagement barriers
Negative symptoms of psychosis 4 2 3
Prior trauma 3 – 3
Stigma 4 – 4
Lacking insight 7 2 5
Substance use 12 5 6
Criminal justice issues 2 – 2
Low intellectual functioning 3 – 3
Family conflict and lack of support 13 3 4
Limited social support 17 4 4
Poverty/lack of basic resources 9 2 7
Change in insurance status 15 14 6
Change in employment status 3 2 2
Housing instability/homelessness 6 5 5
Medication non-adherence 21 6 8

424 The Journal of Behavioral Health Services & Research 46:3 July 2019

Grounded theory

Four major themes were drawn from the key informant interviews: (1) multidisciplinary team
approach, (2) provider flexibility, (3) shared decision-making, and (4) patient engagement barriers.

Multidisciplinary Team Approach Across program services, providers reported that the
multidisciplinary team approach within CSC enabled them to offer multiple layers of support to
patients. According to a CSC provider, Bworking as a multidisciplinary team, we are able to
reinforce trust and connection between patients and other providers on the treatment team.^
Multiple providers reported using the team-based approach to address patient medication adherence
and improve functioning. A few providers identified weekly treatment team meetings as beneficial
in increasing their awareness of patient clinical issues and engagement problems. A theme emerged
among providers that the emphasis on patient functioning was a strength of the CSC program, and
through multidisciplinary teamwork, they could collectively reinforce life skills to improve patient
functioning. One patient reported that the CSC program helped her Bsee other options and gain
independence.^ Working with her CSC treatment team, she reported reaching her psychotherapy
goals to reduce hopelessness and suicidal thoughts and finding a medication regimen that worked.

Table 3
CSC sample characteristics

Characteristic Total N (%) Treatment retention
≥ 9 months N (%)

Chi-square (df) p value

Sex 3.612 (1) 0.057
Male 76 (58.9) 50 (65.8)
Female 53 (41.1) 26 (49.1)
Age (years) – 0.922
Age mean (SD) 23.14 (3.35) 23.12 (3.32) –
Race/ethnicity 7.52

Literature Review

1Arnfred B, et al. BMJ Open 2022;12:e051147. doi:10.1136/bmjopen-2021-051147

Open access

Group cognitive behavioural therapy
with virtual reality exposure versus
group cognitive behavioural therapy
with in vivo exposure for social anxiety
disorder and agoraphobia: a protocol for
a randomised clinical trial

Benjamin Arnfred ,1 Peter Bang,1,2 Carsten Hjorthøj ,1,3
Clas Winding Christensen,1 Kirsten Stengaard Moeller,1 Morten Hvenegaard,1
Lone Agerskov,1 Ulrik Krog Gausboel,1 Ditte Soe,1 Peter Wiborg,1
Christopher Ian Schøler Smith,1 Nicole Rosenberg,1 Merete Nordentoft1,4

To cite: Arnfred B, Bang P,
Hjorthøj C, et al. Group
cognitive behavioural therapy
with virtual reality exposure
versus group cognitive
behavioural therapy with in
vivo exposure for social anxiety
disorder and agoraphobia:
a protocol for a randomised
clinical trial. BMJ Open
2022;12:e051147. doi:10.1136/
bmjopen-2021-051147

► Prepublication history and
additional supplemental material
for this paper are available
online. To view these files,
please visit the journal online
(http://dx.doi.org/10.1136/
bmjopen-2021-051147).

Received 26 May 2021
Accepted 24 November 2021

For numbered affiliations see
end of article.

Correspondence to
Dr Benjamin Arnfred;
barn0006@ regionh. dk

Protocol

© Author(s) (or their
employer(s)) 2022. Re- use
permitted under CC BY- NC. No
commercial re- use. See rights
and permissions. Published by
BMJ.

ABSTRACT
Introduction Anxiety disorders have a high lifetime
prevalence, early- onset and long duration or chronicity.
Exposure therapy is considered one of the most effective
elements in cognitive behavioural therapy (CBT) for
anxiety, but in vivo exposure can be challenging to access
and control, and is sometimes rejected by patients
because they consider it too aversive. Virtual reality allows
flexible and controlled exposure to challenging situations
in an immersive and protected environment.
Aim The SoREAL- trial aims to investigate the effect of
group cognitive behavioural therapy (CBT- in vivo) versus
group CBT with virtual reality exposure (CBT- in virtuo) for
patients diagnosed with social anxiety disorder and/or
agoraphobia, in mixed groups.
Methods and analysis The design is an investigator-
initiated randomised, assessor- blinded, parallel- group
and superiority- designed clinical trial. Three hundred
two patients diagnosed with social anxiety disorder and/
or agoraphobia will be included from the regional mental
health centres of Copenhagen and North Sealand and
the Northern Region of Denmark. All patients will be
offered a manual- based 14- week cognitive behavioural
group treatment programme, including eight sessions
with exposure therapy. Therapy groups will be centrally
randomised with concealed allocation sequence to either
CBT- in virtuo or CBT- in vivo. Patients will be assessed
at baseline, post- treatment and 1- year follow- up by
treatment blinded researchers and research assistants.
The primary outcome will be diagnosis- specific symptoms
measured with the Liebowitz Social Anxiety Scale for
patients with social anxiety disorder and the Mobility
Inventory for Agoraphobia for patients with agoraphobia.
Secondary outcome measures will include depression
symptoms, social functioning and patient satisfaction.
Exploratory outcomes will be substance and alcohol use,
working alliance and quality of life.
Ethics and dissemination The trial has been approved by the
research ethics committee in the Capital Region of Denmark.

All results, positive, negative as well as inconclusive, will be
published as quickly as possible and still in concordance
with Danish law on the protection of confidentially and
personal information. Results will be presented at national
and international scientific conferences. The trial has obtained
approval by the Regional Ethics Committee of Zealand (H-
6- 2013- 015) and the Danish Data Protection Agency (RHP-
2014- 009- 02670). The trial is registered at ClinicalTrial. gov
as NCT03845101. The patients will receive information on
the trial both verbally and in written form. Written informed
consent will be obtained from each patient before inclusion in
the trial. The consent form will be scanned and stored in the
database system and the physical copy will be destroyed. It is
emphasised that participation in the trial is voluntary and that
the patient can withdraw his or her consent at any time without
consequences for further and continued treatment.
Trial registration number NCT03845101.

Strengths and limitations of this study

► The present study will be the first large randomised
clinical trial to investigate virtual reality exposure
therapy for social anxiety disorder and agoraphobia
in group therapy.

► The present study is very closely integrated with
clinical practice, making results highly transferable
to similar real- life settings.

► Mixing patients with social anxiety disorder and ag-
oraphobia in the same therapy groups have never
been investigated systematically, which may con-
found the interpretation of results.

► Because the study is embedded in an outpatient
hospital setting, the intervention was designed to
be flexible. This increases the ecological validity
but also the risk of systematic bias in treatment
administration.

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2 Arnfred B, et al. BMJ Open 2022;12:e051147. doi:10.1136/bmjopen-2021-051147

Open access

BACKGROUND
Social anxiety disorder is characterised by paying attention
to oneself in an exaggerated manner and having marked
fear of being negatively evaluated by other people.1 2
Agoraphobia is characterised by avoidance or enduring
with dread, situations in which escape is perceived diffi-
cult or where help might not be available in the event
of a panic attack, panic- like symptoms or incapacitating
symptoms such as loss of bladder and/or bowel control.1 3
Both social anxiety disorder and agoraphobia are associ-
ated with marked functional consequences.1 In Denmark,
anxiety disorders represent the costliest disease burden
in terms of lost production, due to their early onset, long
duration and high prevalence.4

The first- line treatment for social anxiety disorder and
agoraphobia is cognitive behavioural therapy (CBT) with
exposure therapy.5 6 Several meta- analyses have found
that patients with social anxiety disorder and agoraphobia
respond well to CBT with exposure therapy, provided in
individual as well as group format.7–10 Exposure therapy
aims to change expectations and emotional responses
associated with feared stimuli, by exposing the patient to
the stimuli and challenging the patients’ expectancies of
the likelihood and consequences of a feared outcome.11
However, in clinical practice, in- vivo exposure stimuli can
be difficult to access and control and patients or therapists
sometimes reject the treatment, because they consider it
too aversive or too logistically demanding.12–14

Virtual reality exposure therapy for social anxiety disorder and
agoraphobia
Virtual reality (VR) technology allows the user to experi-
ence virtually mediated environments that are perceived
as real or almost real, due to multisensory stimulation and
blocking of real- world sensory input. Numerous possibili-
ties for psychological intervention using VR are currently
being researched owing to its immersive quality.15 16 As a
therapy tool, VR is most widely used to perform Virtual
Reality Exposure Therapy (VRET),16 17 either as a stand-
alone treatment, for example,18 or integrated into a CBT
treatment, for example.19

The use of VR allows flexible and controlled exposure
to challenging situations in an immersive and safe envi-
ronment. Therefore, using VRET can mitigate the chal-
lenges of in- vivo exposure therapy by producing greater
user acceptance and access to situations that would other-
wise be too difficult to control, too resource- intensive to
find and/or have unacceptable confidentiality risks.15 19 20
Based on this, VRET may improve the efficacy and cost-
effectiveness of psychotherapeutic interventions for
anxiety disorders.

Recent reviews and meta- analysis of VRET, either as a
standalone treatment or combined with cognitive inter-
ventions, conclude that VRET is more effective than wait-
list and placebo control and equally as effective as first- line
treatment controls for anxiety disorders.21–23 However, in
one meta- analysis, the authors find significantly worse
treatment effects of VRET for social anxiety disorder,

when compared with control groups that received equal
amounts of in- vivo exposure.24 It has been suggested that
it is more difficult to produce VRET environments for
social anxiety disorder, as compared with other phobic
disorders because human interaction is complex and
therefore difficult to realistically recreate25 which may
explain these results. Accordingly, the same meta- analysis
found no significant difference in treatment efficacy for
CBT with VRET versus CBT with in- vivo exposure for
agoraphobia and specific phobia.24

In general, there is a scarcity of high- quality randomised
clinical trials evaluating the use of VRET for social anxiety
disorder and agoraphobia.16 26 27 For social anxiety
disorder, there are five trials published, the largest having
97 participants.18 19 28–30 For agoraphobia, there are six
trials published, the largest having 80 participants.31–36 All
in all, the evidence base for using VRET compared with
in- vivo exposure for social anxiety disorder and agora-
phobia remain small. Therefore, larger studies that capi-
talise on the unique qualities of VRET are needed.

VR exposure in group therapy
VRET has never been investigated in a group format.
Group therapy for social anxiety disorder and agoraphobia
is popular in outpatient settings because it has similar
treatment efficacy37–39 and is proposed to have better cost
efficiency, compared with individual therapy.37 39 However,
the claim of cost efficiency for social anxiety disorder is
disputed, at least in a UK mental healthcare setting.40
Beyond that, therapeutic interpersonal processes such as
peer learning and modelling has been suggested to be
a distinct benefit of group therapy,41 42 though this has
never been systematically evaluated for mixed anxiety
groups. A suggested drawback of group CBT compared
with individual CBT is that in- vivo exposure in group
therapy is restrained by the logistics of managing several
patients simultaneously, leading to comparatively less
individualised exposure exercises.43 44

The use of VRET in group therapy may therefore be
especially beneficial, since it should allow for individual-
ised exposure, as well as a greater amount of exposure
therapy because less time will be spent on logistical issues
(transport, planning, waiting, and so on), while at the
same time retaining the proposed benefits of the thera-
peutic interpersonal processes and cost- efficiency.

Treatment of social anxiety disorder and agoraphobia in the
Danish mental health system
In the Danish mental health services, patients with social
anxiety disorder or agoraphobia as their primary diag-
nosis are generally offered group CBT. To reduce wait
time, patients with these diagnoses are treated in the
same therapy groups, generally referred to as ‘mixed
anxiety groups’ or ‘phobia groups’. These mixed anxiety
groups are considered to be as effective as diagnosis-
specific groups, due to the overlap in symptoms and diag-
nostic criteria,45 high degree of comorbidity,46 as well as

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recent evidence of the acceptable treatment efficacy of
CBT- based transdiagnostic therapies.47

However, it is worth noting that the pragmatic mixed
anxiety group format has never been systematically eval-
uated and that the official treatment recommendation
remains diagnoses- specific CBT delivered in group or
individually.48 To maximise the study’s clinical represen-
tativeness, as defined by Shadish et al,49 the treatment
structure in the present study, including the comperator,
will mimic the treatment offered by the Danish mental
health services.

Aim and objectives
In summary in- vivo exposure is considered effective,
but can be challenging to perform. VRET may alleviate
these challenges. However, the usefulness of VRET for
social anxiety disorder and agoraphobia remains unclear.
Larger studies that capitalise on the benefits of VRET are
needed. Group therapy may be one way to capitalise on
the benefits of VRET because it could allow for more indi-
vidualised exposure exercises. Mixed anxiety groups are
commonly used in Danish mental healthcare to reduce
wait time, but have not been systematically evaluated.
The treatment, inclusion and exclusion criteria described
in the present study match the eligibility criteria for
treatment and treatment format of the Danish mental
healthcare system to maximise transferability of results to
clinical practice.

Therefore, the SoREAL trial aims to evaluate the treat-
ment efficacy of VRET in mixed anxiety CBT groups
(CBT- in virtuo) compared with mixed anxiety CBT groups
where exposure therapy is performed in- vivo (CBT- in
vivo).

Thus, in the SoREAL trial, the following hypotheses’
will be tested:

Primary hypothesis
1. Post- treatment, patients treated with CBT- in virtuo will

have a lower level of anxiety symptoms compared with
patients treated with CBT- in vivo, measured as total
scores on the Liebowitz Social Anxiety Scale (LSAS)
for patients with social anxiety disorder and the
Mobility Inventory for Agoraphobia (MIA) for patients
with agoraphobia converted to the percentage of max-
imum possible (POMP) scores and averaged within
treatment arms.

Secondary hypotheses
1. One year after treatment, patients treated with CBT- in

virtuo will have lower levels of anxiety symptoms com-
pared with patients treated with CBT- in vivo.

2. Post- treatment and 1 year after treatment, patients
treated with CBT- in virtuo will have lower levels of fear
of negative evaluation compared with patients treated
with CBT- in vivo.

Overall, we believe that the SoREAL trial will contribute
with knowledge about the efficacy and feasibility of VRE
for treating social anxiety disorder and agoraphobia in

a clinical outpatient setting. The results of this trial may
guide future applications of VR in clinical settings across
a wide breadth of use cases.

METHODS AND DESIGN
This article was written in accordance with the Standard
Protocol Items: Recommendations for Interventional
Trials (SPIRIT) 2013 explanation and elaboration: guid-
ance for protocols of clinical trials.50 The SPIRIT Check-
list was followed and the SPIRIT flowchart was used (see
online supplemental file 1 and figure 1).

Recruitment
The SoREAL trial is embedded directly into five outpa-
tient clinics offering group CBT for social anxiety
disorder and agoraphobia. These clinics are part of the
Danish mental healthcare system. To be eligible for treat-
ment in these clinics, patients must be referred by their
primary care physicians to a Centre for Visitation and
Diagnosis in their area, where their symptomatology will
be assessed. At the Centre for Visitation and Diagnosis,
they must be referred to one of the five outpatient clinics
involved in the study. At the outpatient clinic, the patient
will again be clinically assessed, and a diagnosis and treat-
ment plan will be formulated. If social anxiety disorder
and/or agoraphobia is considered the primary diagnosis
for the patient, they will be asked if they are interested in
getting more information about the trial. If they consent
to it, their contact details will be given to a researcher,
who will invite them to an interview concerning the study.

Mini International Neuropsychiatric Interview (MINI),
V. 7.0 for DSM- 5 will be used to screen for diagnosis.
Psychometric analyses of the MINI have demonstrated
acceptable test–retest and inter- rater reliability.51 52 Diag-
nostic screening is sufficient due to the thorough assess-
ment from both Centre for Visitation and Diagnostics and
the outpatient clinics which must have confirmed social
anxiety disorder or agoraphobia as the primary diagnosis
of the patient, for the patient to be eligible for the study.
If eligibility is confirmed, informed consent is acquired
(see online supplemental file 2, for a model consent
form). Patients who cannot or will not participate in the
study will be offered treatment as usual, which is identical
to the control group treatment. Inclusion and exclusion
criteria were based on the eligibility criteria for receiving
the treatment package in Danish outpatient clinics.

Inclusion criteria
1. Fulfilling diagnostic criteria for social anxiety disorder

and/or agoraphobia.
2. Age 18–75 years.
3. Sufficient knowledge of the Danish language.
4. Informed consent

Exclusion criteria
1. Alcohol or drug dependence

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Feasibility
Five psychotherapeutic outpatient clinics are involved in
the study. All patients referred to these clinics with the
relevant diagnosis, who also agree to be contacted, will be
invited to an interview about their potential participation.
Each of the clinics provide treatment for approximately
30 patients with social anxiety disorder and/or agora-
phobia every year. Thus we anticipate that 450 patients
will be eligible for the trial during a 3- year recruitment
period. We expect a high eligibility rate, due to the previ-
ously mentioned assessment procedures the patients will
have completed. We also expect a high acceptance rate,
due to the novel use of VR technology and the use of a
control group that is identical to the treatment they would
be offered if they refused participation. See figure 2 for a
flow diagram of the SoREAL trial.

Treatment format
The treatment for social anxiety disorder and agora-
phobia offered at the outpatient clinics must follow the
national guidelines for the treatment of these disorders.
The guidelines are encapsulated in specified ‘treatment

packages’. For social anxiety disorder and agoraphobia,
this package contains:

► 1 hour of assessment.
► 1 hour of individual therapy in preparation for group

therapy
► 1 hour of psychometric testing.
► 14 sessions of 2 hours of group therapy
► 1.5 hours of next of kin involvement
► 1 hour of pharmacological treatment planning with a

psychiatrist
► 2.5 hours coordination with social services, relapse

prevention and follow- up meetings.
Not all of this is necessary for every patient, but every

patient can receive every part of the package, should they
want to. The treatment in the present study must live up
to the standards of the national guidelines. Patients are
not allowed to be in any other form of psychotherapeutic
treatment.

The therapeutic intervention is manual- based cognitive-
behavioural CBT group adapted from the approach of
Turk et al53 and Graske and Barlow54 with worksheets

Figure 1 Overview of data collection. CBT, cognitive behavioural therapy.

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from Rosenberg et al55 and inspiration from Bouchard
et al.56 The treatment will consist of 14 weekly 2- hour
group sessions following the manual to ensure equal
and uniform treatment for every patient throughout the
study. The manual allows flexibility to ensure clinically
representative conditions.49 For example, it is allowed to
change the order of the sessions if it is considered bene-
ficial for the group and multiple exercises are optional.
However, the time dedicated to exposure is fixed in both
groups. Concurrent psychopharmacological treatment is
allowed in both intervention arms.

Groups will consist of 8–9 patients with social anxiety
disorder and/or agoraphobia as their primary diagnosis,
and every session will be led by two trained clinicians (ie,
psychologists, psychiatrists or psychotherapists) with prac-
tical experience in CBT and in vivo exposure. Throughout
the course of the study, the clinicians involved will treat
both CBT- in vivo and CBT- in virtuo groups. Medical
consultation, acute individual sessions, supplementary
social counselling and physical therapy are possible in
both intervention arms. In both intervention arms, the
sessions dedicated to exposure are scheduled from the
fifth to the eleventh session with approximately 45 min
of exposure in each session. From the fifth session and
onwards, all patients in both interventions will have
in- vivo exposure as homework. The cognitive therapy
strategies used in the non- exposure sessions (first four
and last two therapy sessions) are as follows: (1) intro-
duction to CBT; (2) psychoeducation about anxiety and
cognitive restructuring of dysfunctional assumptions and
beliefs; (3) shifting self- focused attention and modifying

cognitive distortions; (4) developing an understanding
of safety behaviour and the rationale of exposure; (5)
evaluation, discussion and feedback on the use of patient-
acquired techniques; and (6) relapse prevention. In
both conditions, the exposure exercises aim to develop
adaptive responses to anxiety- provoking situations, rein-
force cognitive restructuring by framing exercises as
behavioural experiments (though these were limited by
the non- interactive medium), train attention exercises,
train general cognitive strategies (eg, identifying negative
automatic thoughts) and train social skills. See tables 1
and 2 for an overview of the content of the CBT sessions
for both conditions.

In the in virtuo condition, exposure will take place
during 8 out of the 14 group sessions, as in the CBT- in
vivo condition. Patients will be exposed to VR situations,

Figure 2 Flow diagram of the SoREAL trial. CBT, cognitive
behavioural therapy.

Table 1 Group cognitive behavioural therapy manual
session overview for social anxiety disorder and
agoraphobia

Session Content

Individual
session

Case conceptualisation, psychoeducation on
CBT, treatment goal, introduction to treatment
setting.

1 Psychoeducation about anxiety, CBT anxiety
model.

2 Psychoeducation about anxiety, registration of
thoughts, feelings, behaviour and introduction to
cognitive restructuring.

3 Psychoeducation and exercise:
cognitive bias, attention and self- focus, repetition
about cognitive restructuring, attention exercises.

4 Psychoeducation about exposure therapy,
optionally, an introductory exposure exercise.

5 Exposure therapy.

6 Behavioural experiments in exposure exercises.

7 Repetition of the methods presented so far,
additional attention/mindfulness exercise linked
to exposure.

8 Conversational skills and small- talk exposure
exercises.

9 Introduction to core beliefs, additional exposure
exercises.

10 Repetition of core beliefs, resources and skills,
additional exposure exercises.

11 Exposure therapy, out of the clinic.

12 Repetition and evaluation of methods learnt/used
so far, revising problem–goal list.

13 Evaluation, discussion and feedback on the
different methods used by each patient.

14 Maintenance and relapse prevention, review of
skills, review of progress and future goals, plan
for continued exposures, relapse prevention
strategies.

CBT, cognitive behavioural therapy.

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which are relevant to them, and which they are motivated
to engage in. Patients in CBT- in virtuo condition will be
assigned in vivo exposure homework between sessions in
the same way as the CBT- in vivo group.

Fidelity to the treatment manual
The intervention is manual- based, which improves the
standardisation of the treatment. Fidelity to the treat-
ment manual will be assessed through a self- report ques-
tionnaire answered by the clinicians at five different
time points throughout each group treatment. The
questionnaire (and the timepoints when it is delivered)
are designed to correspond to the treatment manual.
This type of fidelity measurement has proved useful and
adequate in trials where the effect of treatment is tested.57

The VR headsets will also record statistics of the use of
the 360o films. This data show which specific scenes were
watched and how much and can be matched to the indi-
vidual patient. This data will be used to keep track of the
VR usage throughout the study to see how well it matches
the treatment manual.

Treatment completion and discontinuation
Criteria for treatment completion, partial treatment and no
treatment were based on clinical guidelines for writing
epicrisis as well as discussions within the research group.

► The attendance of 0 or more group therapy sessions
will be coded as ‘treatment completion’.

► The attendance of between four to nine group therapy
sessions will be coded as ‘partial treatment’.

► The attendance of less than four group therapy
sessions will be coded as ‘no treatment’.

Treatment will be discontinued if participants do not
show up to treatment 3 weeks in a row and cannot be
contacted after multiple attempts by the therapists. Partic-
ipants who have their treatment discontinued will still be
included in the statistical analysis.

VR equipment
The patients receiving the in virtuo exposure will be
immersed using an Oculus Go head- mounted display,
enabling viewing of 360° spherically camera- recorded
VR environments. The VR scenarios will thus be high-
resolution 360° stereoscopic films, that are played around
the viewer. For audio, the patients will use high- quality
sound- blocking headphones. For ease of use, the indi-
vidual videos will be administered from an app that has
been designed to be as intuitive to operate as possible.
The patient will only have to put on the headset, adjust
the focus and choose the desired environment by looking
at it in the app. 360° video was chosen because it gives the
most photorealistic visuals, while also being the cheapest
to produce. The downside is that it does not allow direct
user interaction (eg, the viewer cannot affect the environ-
ment in any way). To circumvent this, there are multiple
junctions throughout the films where the actors will talk
directly and unsolicited to the viewer (eg, greetings,
common questions), while also allowing time for the
viewer to respond. The actors respond in a generic way to
the actions of the viewer. Unsolicited and direct referral
from a virtual environment seems to be an essential factor
in triggering realistic responses to it.58 Though the non-
interactability of the environment limits the flexibility of
behavioural experiments, it does not make them impos

Literature Review

1

Running head: LITERATURE REVIEW

6

LITERATURE REVIEW

Literature Review

Stratford University

Literature Review

This literature review will discuss and critique five articles addressing new graduate nurse retention, in relation to my research question of, “For new graduate nursing students hired into INOVA Fairfax ED, does the use of a buddy program for the first year of employment reduce the future risk of turnover compared with no post-orientation intervention?”.

Retention of new graduate nurses in all nursing specialties is imperative. Not only is it cost effective to increase the rate of retention of new graduates, the decrease in turnover will improve staffing ratios and patient outcomes. There is a need for research on post-orientation interventions such as a buddy program to decrease turnover of new graduate nurses. Building relationship between new and experienced staff members in crucial, because we are already experiencing a shortage of nurses. Therefore, we need to find a way to stop new nurses form leaving their positions within the first year, and further decrease the likelihood they will leave the profession altogether.

The first study reviewed was a phenomenological study seeking to understand the experiences of graduate nurses and their transition into professional practice (Kelly & McAllister, 2013). A two-year study in which fourteen out of sixty-five senior nursing students from an Australian university participated. The subjects varied in age and background. The preceptors had minimal training received by the hospital that would affect the reliability of this study. Data was collected through semi-structured interviews and journals kept by the participants. The data was collected and inputted into NVivo, an analysis tool, to generate themes throughout the data. There was consistency of data collection and the analysis tools used were appropriate for this study.

The size of this study was limited, which could affect generalizability of the findings. However, the details provided by the participants will aid in the understanding barriers and facilitators of quality learning through clinical preceptors (Kelly & McAllister, 2013). The information obtained through this study expresses a deep need for relationship building between the preceptor and the student to enhance the learning process and build confidence as a new nurse.

The second study, a phenomenological study, followed seven new graduate nurses. All of which varied in age, degrees (i.e. associates or bachelor’s), hospitals, and department. The inclusion criteria consisted of being a new graduate nurse and participation in a new grad residency program. Data collection was obtained through audio recorded interviews performed by the primary researcher. Each interview lasted forty-five to sixty minutes in a setting selected by the participant, which shows consistency in the collection of the data. Great consideration and rigor was taken into account concerning credibility, transferability, dependability, and confirmability of the data (Moore & Cagle, 2012). Two experienced researchers individually collectively analyzed this data to confirm emerging themes. Some limitations to this research was concerning the background and history of the participants had including prior patient care experience.

The third study reviewed was a convergent mixed methods study which was a part of a larger project. The larger project was evaluating the effectiveness of clinical supervision for new graduate nurses that were working in an acute care setting (Hussein, Everett, Ramjan, & Salamonson, 2017). The sample size was one hundred-forty new graduate nurses which were enrolled in a twelve-month long transition program at a Sydney hospital. The Manchester Clinical Supervision Scale (MCSS-26) was used to assess the new graduate nurse’s perception of the quality of clinical supervision. In addition, the Practice Environment Scale -Australia (PES-AUS) was used to assess satisfaction with the clinical environment. These tools allowed for consistency in the collection of the data. Other factors were also taken into consideration such as age, gender, and prior experience in the healthcare profession (Hussein, Everett, Ramjan, & Salamonson, 2017). The quantitative data was analyzed using a statistical software package (IBM SPSS Statistics Version 22), and “continuous variables were assessed for normality using the Kolmogorov-Smirnov test, and expressed as median and range” (Hussein, Everett, Ramjan, & Salamonson, 2017, p.4). This form of data collection and analysis was appropriate for this study, and tools have been proven to be reliable. Although there are limitations to this study, which include the study being conducted at only one facility. Additionally, the self-repot methods used for the qualitative portion of this survey were not very reliable.

The fourth study reviewed was a retrospective descriptive evaluative design, which looked at retention between two groups of graduate RNs in the critical care units of Cohen Children’s Medical Center (CCMC) before and after the initiation of the Pediatric Fellowship Program (PNFP) (Friedman, Delaney, Schmidt, Quinn, & Macyk, 2013). A nonprobability convenience sample was used for this study. The sample in this study consists of new graduate RNs hired to begin nursing orientation during March 2005 to August 2007, prior to the initiation of the PNFP, and September 2007 to March 2010, after the initiation of PNFP (Friedman, Delaney, Schmidt, Quinn, & Macyk, 2013). The collection of data regarding retention of both groups was retrieved through the CCMC’s HR department. The data for both groups was measured longitudinally at four different points after the commencement of the new graduate’s program. There was consistency in the collection of data, as well as reliability in the source of the data. The tool used to measure all data was made specifically for this study, appropriate for this data analysis. Limitations in this study are concerned with the retrospective design. Other variables that may have affected new graduate nurse retention are those that the researchers were unable to detect. There was a significant increase in the new graduate nurse retention once the PNFP was implemented (Friedman, Delaney, Schmidt, Quinn, & Macyk, 2013).

The last study which I reviewed was a qualitative study aimed to reveal the experiences and perceptions of nurses regarding turnover to identify strategies to improve retention, job satisfaction, and performance (Dawson, Stasa, Roche, Homer, & Duffield, 2014). The sample consisted of three hundred and sixty-two nurses working on a medical and surgical unit from three of Australia’s states/territories. This study was part of a larger project which examined the relationship between turnover and patient, organizational, and staff outcomes. The study distributed a survey with an open-ended question at the end, which allowed the participants to elaborate on needs and concerns of turnover. Statements were then analyzed using NVivo a qualitative data analysis tool, and themes emerged from this analysis. There was consistency in the collection of the data, and reliability of the instruments used. Out of this data three themes emerged. One which relates to the given research question about the factors that directly affect turnover. Factors listed under this theme include limited career options, poor staff support, poor recognition, and poor staff attitudes, all of which contributes to turnover. This study showed the importance of the relationships between the staff members to reduce the rate of turnover. limitations to this study such as only twenty-two percent of the sample from the larger survey answered the open question. Due to the limited response this may potentially affect the data quality, because this may not be the typical nurse’s perspective.

After reviewing the research that could be found on new graduate nurse retention and mentoring programs I have found there is little research on programs after the orientation phase of the transition from student to being in the workforce. Throughout the research there is a trend of relationship building among staff, bridging the gap between new and experienced nurses. In many of the reviewed literature during interviews, new graduates consistently expressed a lack of support, especially after the orientation phase. Moving forward research needs to be addressed to evaluate if a buddy program for new nurses is effective in increasing retention and decreasing turnover.

References

Dawson, A. J., Stasa, H., Roche, M. A., Homer, C. S. E., & Duffield, C. (2014). Nursing churn and turnover in Australian hospitals: Nurses perceptions and suggestions for supportive strategies. BMC Nursing, 13, 11. doi:http://dx.doi.org.prx-stratford.lirn.net/10.1186/1472-6955-13-11

Friedman, M. I., Delaney, M. M., Schmidt, K., Quinn, C., & Macyk, I. (2013). Specialized new graduate RN pediatric orientation: A strategy for nursing retention and its financial impact. Nursing Economics, 31(4), 162.

Hussein, R., Everett, B., Ramjan, L. M., Hu, W., & Salamonson, Y. (2017). New graduate nurses’ experiences in a clinical specialty: a follow up study of newcomer perceptions of transitional support. BMC nursing, 16(1), 42.

Kelly, J., & McAllister, M. (2013). Lessons students and new graduates could teach: a phenomenological study that reveals insights on the essence of building a supportive learning culture through preceptorship. Contemporary nurse, 44(2), 170-177.

Moore, Penny, PhD, R.N., C.N.L., & Cagle, Carolyn Spence, PhD., R.N.C. (2012). The lived experience of new nurses: Importance of the clinical preceptor. The Journal of Continuing Education in Nursing, 43(12), 555-565. doi:http://dx.doi.org.prx-stratford.lirn.net/10.3928/00220124-20120904-29

Literature Review

a) You need to select a minimum of research reports from the literature search that was conducted to justify the PICOT question. One research report must be from a nursing peer-reviewed journal.

b) Next analyze all 5 or more articles.  You need to pay attention to how the research question, purpose, methodology, results, discussion, and conclusion of the paper and how these support the research question. Add your knowledge about research to it and how this affects nursing practice. Last, write a short paper (6-9 pages in total). Include a complete citation for each article you reviewed.

PICOT STATEMENT: For young adults living with schizophrenia, how effective is cognitive behavioral therapy at managing it?

Literature Review

1Arnfred B, et al. BMJ Open 2022;12:e051147. doi:10.1136/bmjopen-2021-051147

Open access

Group cognitive behavioural therapy
with virtual reality exposure versus
group cognitive behavioural therapy
with in vivo exposure for social anxiety
disorder and agoraphobia: a protocol for
a randomised clinical trial

Benjamin Arnfred ,1 Peter Bang,1,2 Carsten Hjorthøj ,1,3
Clas Winding Christensen,1 Kirsten Stengaard Moeller,1 Morten Hvenegaard,1
Lone Agerskov,1 Ulrik Krog Gausboel,1 Ditte Soe,1 Peter Wiborg,1
Christopher Ian Schøler Smith,1 Nicole Rosenberg,1 Merete Nordentoft1,4

To cite: Arnfred B, Bang P,
Hjorthøj C, et al. Group
cognitive behavioural therapy
with virtual reality exposure
versus group cognitive
behavioural therapy with in
vivo exposure for social anxiety
disorder and agoraphobia:
a protocol for a randomised
clinical trial. BMJ Open
2022;12:e051147. doi:10.1136/
bmjopen-2021-051147

► Prepublication history and
additional supplemental material
for this paper are available
online. To view these files,
please visit the journal online
(http://dx.doi.org/10.1136/
bmjopen-2021-051147).

Received 26 May 2021
Accepted 24 November 2021

For numbered affiliations see
end of article.

Correspondence to
Dr Benjamin Arnfred;
barn0006@ regionh. dk

Protocol

© Author(s) (or their
employer(s)) 2022. Re- use
permitted under CC BY- NC. No
commercial re- use. See rights
and permissions. Published by
BMJ.

ABSTRACT
Introduction Anxiety disorders have a high lifetime
prevalence, early- onset and long duration or chronicity.
Exposure therapy is considered one of the most effective
elements in cognitive behavioural therapy (CBT) for
anxiety, but in vivo exposure can be challenging to access
and control, and is sometimes rejected by patients
because they consider it too aversive. Virtual reality allows
flexible and controlled exposure to challenging situations
in an immersive and protected environment.
Aim The SoREAL- trial aims to investigate the effect of
group cognitive behavioural therapy (CBT- in vivo) versus
group CBT with virtual reality exposure (CBT- in virtuo) for
patients diagnosed with social anxiety disorder and/or
agoraphobia, in mixed groups.
Methods and analysis The design is an investigator-
initiated randomised, assessor- blinded, parallel- group
and superiority- designed clinical trial. Three hundred
two patients diagnosed with social anxiety disorder and/
or agoraphobia will be included from the regional mental
health centres of Copenhagen and North Sealand and
the Northern Region of Denmark. All patients will be
offered a manual- based 14- week cognitive behavioural
group treatment programme, including eight sessions
with exposure therapy. Therapy groups will be centrally
randomised with concealed allocation sequence to either
CBT- in virtuo or CBT- in vivo. Patients will be assessed
at baseline, post- treatment and 1- year follow- up by
treatment blinded researchers and research assistants.
The primary outcome will be diagnosis- specific symptoms
measured with the Liebowitz Social Anxiety Scale for
patients with social anxiety disorder and the Mobility
Inventory for Agoraphobia for patients with agoraphobia.
Secondary outcome measures will include depression
symptoms, social functioning and patient satisfaction.
Exploratory outcomes will be substance and alcohol use,
working alliance and quality of life.
Ethics and dissemination The trial has been approved by the
research ethics committee in the Capital Region of Denmark.

All results, positive, negative as well as inconclusive, will be
published as quickly as possible and still in concordance
with Danish law on the protection of confidentially and
personal information. Results will be presented at national
and international scientific conferences. The trial has obtained
approval by the Regional Ethics Committee of Zealand (H-
6- 2013- 015) and the Danish Data Protection Agency (RHP-
2014- 009- 02670). The trial is registered at ClinicalTrial. gov
as NCT03845101. The patients will receive information on
the trial both verbally and in written form. Written informed
consent will be obtained from each patient before inclusion in
the trial. The consent form will be scanned and stored in the
database system and the physical copy will be destroyed. It is
emphasised that participation in the trial is voluntary and that
the patient can withdraw his or her consent at any time without
consequences for further and continued treatment.
Trial registration number NCT03845101.

Strengths and limitations of this study

► The present study will be the first large randomised
clinical trial to investigate virtual reality exposure
therapy for social anxiety disorder and agoraphobia
in group therapy.

► The present study is very closely integrated with
clinical practice, making results highly transferable
to similar real- life settings.

► Mixing patients with social anxiety disorder and ag-
oraphobia in the same therapy groups have never
been investigated systematically, which may con-
found the interpretation of results.

► Because the study is embedded in an outpatient
hospital setting, the intervention was designed to
be flexible. This increases the ecological validity
but also the risk of systematic bias in treatment
administration.

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BACKGROUND
Social anxiety disorder is characterised by paying attention
to oneself in an exaggerated manner and having marked
fear of being negatively evaluated by other people.1 2
Agoraphobia is characterised by avoidance or enduring
with dread, situations in which escape is perceived diffi-
cult or where help might not be available in the event
of a panic attack, panic- like symptoms or incapacitating
symptoms such as loss of bladder and/or bowel control.1 3
Both social anxiety disorder and agoraphobia are associ-
ated with marked functional consequences.1 In Denmark,
anxiety disorders represent the costliest disease burden
in terms of lost production, due to their early onset, long
duration and high prevalence.4

The first- line treatment for social anxiety disorder and
agoraphobia is cognitive behavioural therapy (CBT) with
exposure therapy.5 6 Several meta- analyses have found
that patients with social anxiety disorder and agoraphobia
respond well to CBT with exposure therapy, provided in
individual as well as group format.7–10 Exposure therapy
aims to change expectations and emotional responses
associated with feared stimuli, by exposing the patient to
the stimuli and challenging the patients’ expectancies of
the likelihood and consequences of a feared outcome.11
However, in clinical practice, in- vivo exposure stimuli can
be difficult to access and control and patients or therapists
sometimes reject the treatment, because they consider it
too aversive or too logistically demanding.12–14

Virtual reality exposure therapy for social anxiety disorder and
agoraphobia
Virtual reality (VR) technology allows the user to experi-
ence virtually mediated environments that are perceived
as real or almost real, due to multisensory stimulation and
blocking of real- world sensory input. Numerous possibili-
ties for psychological intervention using VR are currently
being researched owing to its immersive quality.15 16 As a
therapy tool, VR is most widely used to perform Virtual
Reality Exposure Therapy (VRET),16 17 either as a stand-
alone treatment, for example,18 or integrated into a CBT
treatment, for example.19

The use of VR allows flexible and controlled exposure
to challenging situations in an immersive and safe envi-
ronment. Therefore, using VRET can mitigate the chal-
lenges of in- vivo exposure therapy by producing greater
user acceptance and access to situations that would other-
wise be too difficult to control, too resource- intensive to
find and/or have unacceptable confidentiality risks.15 19 20
Based on this, VRET may improve the efficacy and cost-
effectiveness of psychotherapeutic interventions for
anxiety disorders.

Recent reviews and meta- analysis of VRET, either as a
standalone treatment or combined with cognitive inter-
ventions, conclude that VRET is more effective than wait-
list and placebo control and equally as effective as first- line
treatment controls for anxiety disorders.21–23 However, in
one meta- analysis, the authors find significantly worse
treatment effects of VRET for social anxiety disorder,

when compared with control groups that received equal
amounts of in- vivo exposure.24 It has been suggested that
it is more difficult to produce VRET environments for
social anxiety disorder, as compared with other phobic
disorders because human interaction is complex and
therefore difficult to realistically recreate25 which may
explain these results. Accordingly, the same meta- analysis
found no significant difference in treatment efficacy for
CBT with VRET versus CBT with in- vivo exposure for
agoraphobia and specific phobia.24

In general, there is a scarcity of high- quality randomised
clinical trials evaluating the use of VRET for social anxiety
disorder and agoraphobia.16 26 27 For social anxiety
disorder, there are five trials published, the largest having
97 participants.18 19 28–30 For agoraphobia, there are six
trials published, the largest having 80 participants.31–36 All
in all, the evidence base for using VRET compared with
in- vivo exposure for social anxiety disorder and agora-
phobia remain small. Therefore, larger studies that capi-
talise on the unique qualities of VRET are needed.

VR exposure in group therapy
VRET has never been investigated in a group format.
Group therapy for social anxiety disorder and agoraphobia
is popular in outpatient settings because it has similar
treatment efficacy37–39 and is proposed to have better cost
efficiency, compared with individual therapy.37 39 However,
the claim of cost efficiency for social anxiety disorder is
disputed, at least in a UK mental healthcare setting.40
Beyond that, therapeutic interpersonal processes such as
peer learning and modelling has been suggested to be
a distinct benefit of group therapy,41 42 though this has
never been systematically evaluated for mixed anxiety
groups. A suggested drawback of group CBT compared
with individual CBT is that in- vivo exposure in group
therapy is restrained by the logistics of managing several
patients simultaneously, leading to comparatively less
individualised exposure exercises.43 44

The use of VRET in group therapy may therefore be
especially beneficial, since it should allow for individual-
ised exposure, as well as a greater amount of exposure
therapy because less time will be spent on logistical issues
(transport, planning, waiting, and so on), while at the
same time retaining the proposed benefits of the thera-
peutic interpersonal processes and cost- efficiency.

Treatment of social anxiety disorder and agoraphobia in the
Danish mental health system
In the Danish mental health services, patients with social
anxiety disorder or agoraphobia as their primary diag-
nosis are generally offered group CBT. To reduce wait
time, patients with these diagnoses are treated in the
same therapy groups, generally referred to as ‘mixed
anxiety groups’ or ‘phobia groups’. These mixed anxiety
groups are considered to be as effective as diagnosis-
specific groups, due to the overlap in symptoms and diag-
nostic criteria,45 high degree of comorbidity,46 as well as

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recent evidence of the acceptable treatment efficacy of
CBT- based transdiagnostic therapies.47

However, it is worth noting that the pragmatic mixed
anxiety group format has never been systematically eval-
uated and that the official treatment recommendation
remains diagnoses- specific CBT delivered in group or
individually.48 To maximise the study’s clinical represen-
tativeness, as defined by Shadish et al,49 the treatment
structure in the present study, including the comperator,
will mimic the treatment offered by the Danish mental
health services.

Aim and objectives
In summary in- vivo exposure is considered effective,
but can be challenging to perform. VRET may alleviate
these challenges. However, the usefulness of VRET for
social anxiety disorder and agoraphobia remains unclear.
Larger studies that capitalise on the benefits of VRET are
needed. Group therapy may be one way to capitalise on
the benefits of VRET because it could allow for more indi-
vidualised exposure exercises. Mixed anxiety groups are
commonly used in Danish mental healthcare to reduce
wait time, but have not been systematically evaluated.
The treatment, inclusion and exclusion criteria described
in the present study match the eligibility criteria for
treatment and treatment format of the Danish mental
healthcare system to maximise transferability of results to
clinical practice.

Therefore, the SoREAL trial aims to evaluate the treat-
ment efficacy of VRET in mixed anxiety CBT groups
(CBT- in virtuo) compared with mixed anxiety CBT groups
where exposure therapy is performed in- vivo (CBT- in
vivo).

Thus, in the SoREAL trial, the following hypotheses’
will be tested:

Primary hypothesis
1. Post- treatment, patients treated with CBT- in virtuo will

have a lower level of anxiety symptoms compared with
patients treated with CBT- in vivo, measured as total
scores on the Liebowitz Social Anxiety Scale (LSAS)
for patients with social anxiety disorder and the
Mobility Inventory for Agoraphobia (MIA) for patients
with agoraphobia converted to the percentage of max-
imum possible (POMP) scores and averaged within
treatment arms.

Secondary hypotheses
1. One year after treatment, patients treated with CBT- in

virtuo will have lower levels of anxiety symptoms com-
pared with patients treated with CBT- in vivo.

2. Post- treatment and 1 year after treatment, patients
treated with CBT- in virtuo will have lower levels of fear
of negative evaluation compared with patients treated
with CBT- in vivo.

Overall, we believe that the SoREAL trial will contribute
with knowledge about the efficacy and feasibility of VRE
for treating social anxiety disorder and agoraphobia in

a clinical outpatient setting. The results of this trial may
guide future applications of VR in clinical settings across
a wide breadth of use cases.

METHODS AND DESIGN
This article was written in accordance with the Standard
Protocol Items: Recommendations for Interventional
Trials (SPIRIT) 2013 explanation and elaboration: guid-
ance for protocols of clinical trials.50 The SPIRIT Check-
list was followed and the SPIRIT flowchart was used (see
online supplemental file 1 and figure 1).

Recruitment
The SoREAL trial is embedded directly into five outpa-
tient clinics offering group CBT for social anxiety
disorder and agoraphobia. These clinics are part of the
Danish mental healthcare system. To be eligible for treat-
ment in these clinics, patients must be referred by their
primary care physicians to a Centre for Visitation and
Diagnosis in their area, where their symptomatology will
be assessed. At the Centre for Visitation and Diagnosis,
they must be referred to one of the five outpatient clinics
involved in the study. At the outpatient clinic, the patient
will again be clinically assessed, and a diagnosis and treat-
ment plan will be formulated. If social anxiety disorder
and/or agoraphobia is considered the primary diagnosis
for the patient, they will be asked if they are interested in
getting more information about the trial. If they consent
to it, their contact details will be given to a researcher,
who will invite them to an interview concerning the study.

Mini International Neuropsychiatric Interview (MINI),
V. 7.0 for DSM- 5 will be used to screen for diagnosis.
Psychometric analyses of the MINI have demonstrated
acceptable test–retest and inter- rater reliability.51 52 Diag-
nostic screening is sufficient due to the thorough assess-
ment from both Centre for Visitation and Diagnostics and
the outpatient clinics which must have confirmed social
anxiety disorder or agoraphobia as the primary diagnosis
of the patient, for the patient to be eligible for the study.
If eligibility is confirmed, informed consent is acquired
(see online supplemental file 2, for a model consent
form). Patients who cannot or will not participate in the
study will be offered treatment as usual, which is identical
to the control group treatment. Inclusion and exclusion
criteria were based on the eligibility criteria for receiving
the treatment package in Danish outpatient clinics.

Inclusion criteria
1. Fulfilling diagnostic criteria for social anxiety disorder

and/or agoraphobia.
2. Age 18–75 years.
3. Sufficient knowledge of the Danish language.
4. Informed consent

Exclusion criteria
1. Alcohol or drug dependence

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Feasibility
Five psychotherapeutic outpatient clinics are involved in
the study. All patients referred to these clinics with the
relevant diagnosis, who also agree to be contacted, will be
invited to an interview about their potential participation.
Each of the clinics provide treatment for approximately
30 patients with social anxiety disorder and/or agora-
phobia every year. Thus we anticipate that 450 patients
will be eligible for the trial during a 3- year recruitment
period. We expect a high eligibility rate, due to the previ-
ously mentioned assessment procedures the patients will
have completed. We also expect a high acceptance rate,
due to the novel use of VR technology and the use of a
control group that is identical to the treatment they would
be offered if they refused participation. See figure 2 for a
flow diagram of the SoREAL trial.

Treatment format
The treatment for social anxiety disorder and agora-
phobia offered at the outpatient clinics must follow the
national guidelines for the treatment of these disorders.
The guidelines are encapsulated in specified ‘treatment

packages’. For social anxiety disorder and agoraphobia,
this package contains:

► 1 hour of assessment.
► 1 hour of individual therapy in preparation for group

therapy
► 1 hour of psychometric testing.
► 14 sessions of 2 hours of group therapy
► 1.5 hours of next of kin involvement
► 1 hour of pharmacological treatment planning with a

psychiatrist
► 2.5 hours coordination with social services, relapse

prevention and follow- up meetings.
Not all of this is necessary for every patient, but every

patient can receive every part of the package, should they
want to. The treatment in the present study must live up
to the standards of the national guidelines. Patients are
not allowed to be in any other form of psychotherapeutic
treatment.

The therapeutic intervention is manual- based cognitive-
behavioural CBT group adapted from the approach of
Turk et al53 and Graske and Barlow54 with worksheets

Figure 1 Overview of data collection. CBT, cognitive behavioural therapy.

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from Rosenberg et al55 and inspiration from Bouchard
et al.56 The treatment will consist of 14 weekly 2- hour
group sessions following the manual to ensure equal
and uniform treatment for every patient throughout the
study. The manual allows flexibility to ensure clinically
representative conditions.49 For example, it is allowed to
change the order of the sessions if it is considered bene-
ficial for the group and multiple exercises are optional.
However, the time dedicated to exposure is fixed in both
groups. Concurrent psychopharmacological treatment is
allowed in both intervention arms.

Groups will consist of 8–9 patients with social anxiety
disorder and/or agoraphobia as their primary diagnosis,
and every session will be led by two trained clinicians (ie,
psychologists, psychiatrists or psychotherapists) with prac-
tical experience in CBT and in vivo exposure. Throughout
the course of the study, the clinicians involved will treat
both CBT- in vivo and CBT- in virtuo groups. Medical
consultation, acute individual sessions, supplementary
social counselling and physical therapy are possible in
both intervention arms. In both intervention arms, the
sessions dedicated to exposure are scheduled from the
fifth to the eleventh session with approximately 45 min
of exposure in each session. From the fifth session and
onwards, all patients in both interventions will have
in- vivo exposure as homework. The cognitive therapy
strategies used in the non- exposure sessions (first four
and last two therapy sessions) are as follows: (1) intro-
duction to CBT; (2) psychoeducation about anxiety and
cognitive restructuring of dysfunctional assumptions and
beliefs; (3) shifting self- focused attention and modifying

cognitive distortions; (4) developing an understanding
of safety behaviour and the rationale of exposure; (5)
evaluation, discussion and feedback on the use of patient-
acquired techniques; and (6) relapse prevention. In
both conditions, the exposure exercises aim to develop
adaptive responses to anxiety- provoking situations, rein-
force cognitive restructuring by framing exercises as
behavioural experiments (though these were limited by
the non- interactive medium), train attention exercises,
train general cognitive strategies (eg, identifying negative
automatic thoughts) and train social skills. See tables 1
and 2 for an overview of the content of the CBT sessions
for both conditions.

In the in virtuo condition, exposure will take place
during 8 out of the 14 group sessions, as in the CBT- in
vivo condition. Patients will be exposed to VR situations,

Figure 2 Flow diagram of the SoREAL trial. CBT, cognitive
behavioural therapy.

Table 1 Group cognitive behavioural therapy manual
session overview for social anxiety disorder and
agoraphobia

Session Content

Individual
session

Case conceptualisation, psychoeducation on
CBT, treatment goal, introduction to treatment
setting.

1 Psychoeducation about anxiety, CBT anxiety
model.

2 Psychoeducation about anxiety, registration of
thoughts, feelings, behaviour and introduction to
cognitive restructuring.

3 Psychoeducation and exercise:
cognitive bias, attention and self- focus, repetition
about cognitive restructuring, attention exercises.

4 Psychoeducation about exposure therapy,
optionally, an introductory exposure exercise.

5 Exposure therapy.

6 Behavioural experiments in exposure exercises.

7 Repetition of the methods presented so far,
additional attention/mindfulness exercise linked
to exposure.

8 Conversational skills and small- talk exposure
exercises.

9 Introduction to core beliefs, additional exposure
exercises.

10 Repetition of core beliefs, resources and skills,
additional exposure exercises.

11 Exposure therapy, out of the clinic.

12 Repetition and evaluation of methods learnt/used
so far, revising problem–goal list.

13 Evaluation, discussion and feedback on the
different methods used by each patient.

14 Maintenance and relapse prevention, review of
skills, review of progress and future goals, plan
for continued exposures, relapse prevention
strategies.

CBT, cognitive behavioural therapy.

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which are relevant to them, and which they are motivated
to engage in. Patients in CBT- in virtuo condition will be
assigned in vivo exposure homework between sessions in
the same way as the CBT- in vivo group.

Fidelity to the treatment manual
The intervention is manual- based, which improves the
standardisation of the treatment. Fidelity to the treat-
ment manual will be assessed through a self- report ques-
tionnaire answered by the clinicians at five different
time points throughout each group treatment. The
questionnaire (and the timepoints when it is delivered)
are designed to correspond to the treatment manual.
This type of fidelity measurement has proved useful and
adequate in trials where the effect of treatment is tested.57

The VR headsets will also record statistics of the use of
the 360o films. This data show which specific scenes were
watched and how much and can be matched to the indi-
vidual patient. This data will be used to keep track of the
VR usage throughout the study to see how well it matches
the treatment manual.

Treatment completion and discontinuation
Criteria for treatment completion, partial treatment and no
treatment were based on clinical guidelines for writing
epicrisis as well as discussions within the research group.

► The attendance of 0 or more group therapy sessions
will be coded as ‘treatment completion’.

► The attendance of between four to nine group therapy
sessions will be coded as ‘partial treatment’.

► The attendance of less than four group therapy
sessions will be coded as ‘no treatment’.

Treatment will be discontinued if participants do not
show up to treatment 3 weeks in a row and cannot be
contacted after multiple attempts by the therapists. Partic-
ipants who have their treatment discontinued will still be
included in the statistical analysis.

VR equipment
The patients receiving the in virtuo exposure will be
immersed using an Oculus Go head- mounted display,
enabling viewing of 360° spherically camera- recorded
VR environments. The VR scenarios will thus be high-
resolution 360° stereoscopic films, that are played around
the viewer. For audio, the patients will use high- quality
sound- blocking headphones. For ease of use, the indi-
vidual videos will be administered from an app that has
been designed to be as intuitive to operate as possible.
The patient will only have to put on the headset, adjust
the focus and choose the desired environment by looking
at it in the app. 360° video was chosen because it gives the
most photorealistic visuals, while also being the cheapest
to produce. The downside is that it does not allow direct
user interaction (eg, the viewer cannot affect the environ-
ment in any way). To circumvent this, there are multiple
junctions throughout the films where the actors will talk
directly and unsolicited to the viewer (eg, greetings,
common questions), while also allowing time for the
viewer to respond. The actors respond in a generic way to
the actions of the viewer. Unsolicited and direct referral
from a virtual environment seems to be an essential factor
in triggering realistic responses to it.58 Though the non-
interactability of the environment limits the flexibility of
behavioural experiments, it does not make them impos

Literature Review

1

Title

[Insert your name]

School of Psychology, Capella University

PSY-FP5201: Integrative Project

Literature Review

[Insert your literature review. Make sure all revisions have been addressed. Use this space to introduce your research topic and describe the significance of your topic.]

Theoretical Orientation for the Research Concept

[This section identifies the theories or models that provide the foundation for the research. This section should present the theories or models and explain how the research problem under investigation relates to the theories or models. The theories or models guide the research questions and justify what is being measured (variables) as well as how those variables are related. Use models or theories from seminal sources that provide a reasonable conceptual framework or theoretical foundation to use in developing the research questions, identifying variables, and selecting data collection instruments.]

Review of the Literature

[The overall literature review reflects a foundational understanding of the theory or theories, literature, and research studies related to the topic. For this assignment, the literature review should reflect an effective understanding of the current state of research and literature on the topic. Discuss and synthesize studies related to the topic. Include studies describing and/or connecting the studies on related research such as factors associated with the themes; studies on the instruments used to collect data; studies on the broad population for the study; and/or studies similar to the proposed study. The themes presented and research studies discussed and synthesized in the review of literature demonstrate a working understanding of all aspects of the research topic.]

Synthesis of the Research Findings

[This section requires that you take the research findings discussed in the review of literature above and integrate the findings so that they overlap and create a new understanding of the issues that relate to your research topic.]


Critique of Previous Research Methods

[Synthesize and critique the various methodologies and designs that have been used in prior empirical research related to the study. Discuss why and how your research method and design is the most appropriate for addressing your research problem. You must include supporting examples with proper citation.]


Summary

[This section restates what was written above and provides supporting citations for key points. The summary section reflects that the learner has done due diligence to become well-read on the topic and can demonstrate that this research concept might add to the existing body of research and knowledge on the topic. It synthesizes the information from the chapter to define the gaps or identified research needs arising from the literature and the theories or models to provide the foundation for the study.]

Title

[Insert your title. Follow current edition guidance for creating a title. The title should be a statement and not a question. It should summarize the main idea of the paper. It should be concise and include the variables in the research and their relationship.]

 [Include an introduction before the background of the topic. Restate the topic and address the significance of the study from the literature review. Then, provide a road map covering the primary sections of the concept paper. This should be no longer than a paragraph (5–7 sentences). It does not need a heading.]

Background

[The background of your study is a modified version of your literature review. It reflects the most important points from the main ideas of the literature review. Provide a summary of those main points that highlight the gaps in the literature.]

 

Research Problem

[The research problem is an extension of the research background. This section should include an explicit statement of the research. It needs to address what the research literature states we know, what the literature indicates we know, and what we don’t know, based on the literature. This should be a succinct yet detailed paragraph of 5–7 sentences.]

Research Question

[Your research question should be stated as a question. It should address the research problem addressed in the previous section. State it as a question. Include the hypothesis, null hypothesis, and alternative hypothesis.]

 

Goals and Objectives

[State the goals of this study as if you were going to conduct it or pursue a research proposal. Think about the significance of conducting a study like this and the impact it could have. State the goals in a succinct paragraph of 4–6 sentences. List at least three objectives (what the purpose of the study would be) in numerical form. You may add more if needed.]

1. Goal one.

2. Goal two.

3. Goal three.

 

Population and Sample

[Discuss the setting, general population, target population, and study sample. The discussion of the sample includes the research terminology specific to the type of sampling for the study. When describing the general population consider this as an example:

· the general population (such as students with disabilities).

· target population (such as students with disabilities in one specific location).

· the study sample (students with disabilities in the district who will participate in the study—actual study sample).

When describing the sample size, provide evidence that the sample size is adequate for the research design. If you used the statistical flowchart from the media piece, you should have an appropriate statistical test. As a rule of thumb, consider the following:

· Absolute minimum: 50 cases or participants applicable to studies that use frequencies or descriptive statistics and parametric statistical tests (t-tests, ANOVA, correlation, regression analysis). Additional requirements related to the use of certain statistical analysis procedures may increase that number. Survey research = 10 subjects per survey question.

· An a-priori Power Analysis is required to justify the study sample size based on the anticipated effect size and selected design. Include this in addition to using the literature to support your choices.]

Methodology and Procedures

Quantitative Research

[Define and describe quantitative research. Identify, define, and describe the research design.]


Instruments.
[Provide a detailed discussion of the instrumentation and data collection that includes validity and reliability of the data. Describe the structure of each data collection instrument and data sources (tests, questionnaires, interviews, observations data bases, media, and so on). Specify the type and level of data collected with each instrument.]


Data Collection.
[Describe the procedures for the actual data collection that would allow replication of the study by another researcher, including how each instrument or data source would be used, how, and where data would be collected and recorded.]


Data Analysis.
[Address the what, why, and how of data analysis. Identify
what
statistical nonstatistical analysis would be used. Discuss
why
the statistical analysis is the best selection. Demonstrate
how
the statistical analysis selected aligns with the research question and design.]

 


References

 

Literature Review

ANNOTATED BIBLIOGRAPHY 2






Annotated Bibliography

Rebecca Faino

Capella University

Integrative Project Masters in Psy

Howard Fero

April 30, 2022


Mental illness is among healthcare issues that affect the well-being of individuals in the present society. Mental illness is common in all age groups and ethnic groupings. The effective management of mental illness requires both pharmacological and non-pharmacological interventions. The treatment approaches are targeted at reducing the symptoms and improvement on the behaviors of the affected individuals. Various medications such as antidepressants are used for the management of patients. Also, the psychotherapy interventions such as family therapy, group therapy, and cognitive-behavioral therapy (CBT) help address the issue. For this discussion, the focus is on the presentation of annotated bibliography on the role of cognitive-behavioral therapy in the management of mental illness.


Nakao, M., Shirotsuki, K., & Sugaya, N. (2021). Cognitive-behavioral therapy for the management of mental health and stress-related disorders: Recent advances in techniques and technologies. BioPsychoSocial medicine15(1), 1-4. Doi: 10.1186/s13030-021-00219-w

The authors of the article aimed at determining the effectiveness of the CBT in stressful situations among the clinical and the general population and identifying the advancement in the CBT-related methods. The authors of this article are qualified in the areas of study. They are employed in the department of Psychosomatic Medicine, graduate from the school of the human and social sciences, and a member of the unit of public health and preventive medicine. A literature review method was adopted to search for the studies that were performed from 1987 to 2021 and this led to the identification of the 345 articles that relates to biopsychosocial medicine. The problem of focus in this article is the mental health and stress-associated disorders. The results from this study show that CBT was suitable for various categories of mental problems. The study is, therefore, important for the selected issue of mental illness as it reveals the role of CBT in the successful management of mental and physical issues. The use of the online CBT and the self-help CBT through the use of the mobile applications. The article is relevant since it was recently published by qualified authors.


David, D., Cristea, I., & Hofmann, S. G. (2018). Why cognitive behavioral therapy is the current gold standard of psychotherapy. Frontiers in psychiatry9, 4.  Doi: 10.3389/fpsyt.2018.00004

The authors aimed at looking at the reasons why CBT is considered the present gold standard of psychotherapy. The authors of the articles have qualifications for working in the department of clinical psychology and psychotherapy, the department of the health sciences and policy, and the department of the psychological and brain sciences. The authors failed to give a clear illustration of the method of the study. The findings of the study show that CBT is promoted as one of the effective approaches to dealing with mental illness. It is recognized by the international guideline for psychotherapy treatments and hence can be used as the first-line treatment approach. Even though the authors of the article are qualified in terms of their professionals, the study lacks a clear method of study thus making it hard t decide on using it to support the efforts towards dealing with mental issues.

Carpenter, J. K., Andrews, L. A., Witcraft, S. M., Powers, M. B., Smits, J. A., & Hofmann, S. G. (2018). Cognitive-behavioral therapy for anxiety and related disorders: A meta‐analysis of randomized placebo‐controlled trials. Depression and anxiety35(6), 502-514. DOI: 10.1002/da.22728

The authors focused on examining the effectiveness of CBT for anxiety-associated illness using randomized placebo-controlled trials. The study method involved a literature review using 41 studies with patients diagnosed with various disorders like obsessive-compulsive disorder and general anxiety disorder among others. The authors are employed in the department of

psychological and brain sciences, the department of psychology and institute for mental health research, and the department of psychology among others. The findings of the study show that CBT is a moderately effective in the treatment approach of anxiety disorders than placebo. Therefore, this study is relevant based on the method adopted and its recent publication. Therefore, the interventions such as CBT can be used to address mental illnesses like post-traumatic stress disorder and panic disorder.

He, H. L., Zhang, M., Gu, C. Z., Xue, R. R., Liu, H. X., Gao, C. F., & Duan, H. F. (2019). Effect of cognitive-behavioral therapy on improving the cognitive function in major and minor depression. The Journal of Nervous and Mental Disease, 207(4), 232-238. DOI: 10.1097/NMD.0000000000000954

The article was aimed at investigating the effectiveness of the CBT on the improvement of the cognitive functions in minor depression and major depression. The author adopted the placebo-controlled single blond parallel-group randomized controlled trial. Looking at the affiliation of the authors, they are employed in the psychiatric department and department of psychiatry rehabilitation. This shows that the authors have specific qualifications in the area. The findings of the study show that CBT helps in the alleviation of the depressive symptoms of minor depression and major depression. The article is relevant and important to deal with the issue of mental disorders. Therefore, it can be advocated for or promoted to help in dealing with minor depression and preventing it from occurring. CBT is helpful in the promotion of an increased level of cognitive function.

Gautam, M., Tripathi, A., Deshmukh, D., & Gaur, M. (2020). Cognitive-behavioral therapy for depression. Indian journal of psychiatry62(Suppl 2), S223. Doi: 10.4103/psychiatry.IndianJPsychiatry_772_19


The authors focused on the study of cognitive-behavioral therapy for depression. The article provided is not based on a specific method. The authors are employed as consultant psychiatrists, the department of Psychiatry, the Department of MDG medical college, and consultant psychologists. The evidence from the study shows that CBT helps in the reduction of depressive symptoms as an independent treatment or when combined with other medication, helps in the modification of the underlying schemas or beliefs that assist in the maintenance of the depression, and helping in addressing different psychosocial issues. The information presented in the article is helpful for the research, however, it can be questioned since the authors failed to give clear data about the method of study adopted.

von Brachel, R., Hirschfeld, G., Berner, A., Willutzki, U., Teismann, T., Cwik, J. C., … & Margraf, J. (2019). Long-term effectiveness of cognitive-behavioral therapy in routine outpatient care: a 5-to 20-year follow-up study. Psychotherapy and psychosomatics88(4), 225-235. DOI: 10.1159/000500188

The authors focused on the investigation of the psychological functioning of selected outpatients who were on CBT for various mental disorders. The authors are employed at the mental health research and treatment center, the faculty of business and health, the faculty of psychology and psychotherapy, and the mental health research and treatment center. Based on these qualifications, the authors had the knowledge and information related to the information presented in the article. The author adopted the pre and post-treatment and from the pre-treatment to follow-up evaluation. The study outcomes show the long-term effectiveness of the CBT approach in addressing various groups of mental illnesses like depression, anxiety, and treating disorders. The study is important and can be adopted to tackle the presented issue of mental illness as it shows the effectiveness of the CBT.


Wright, J. H., Owen, J. J., Richards, D., Eells, T. D., Richardson, T., Brown, G. K., … & Thase, M. E. (2019). Computer-assisted cognitive-behavior therapy for depression: a systematic review and meta-analysis. The Journal of clinical psychiatry80(2), 3573. DOI: 10.4088/JCP.18r12188

The authors focused on evaluating the effectiveness of the computer-assisted forms of CBT for the major depressive disorder (MDD) ad examining the role played by the clinical support. The authors derived the data from databases such as Scopus with a focus on the RCT of the computer-assisted CBT for depression and the RCT of the mobile applications for CBT of depression. The outcome of the study shows that computer-assisted CBT with some support from the provider is effective in depressive symptoms. The study is, therefore, important for the selected issues since it shows the computer-assisted CBT approach as one of the interventions that can be adopted.

Yang, Z., Oathes, D. J., Linn, K. A., Bruce, S. E., Satterthwaite, T. D., Cook, P. A., … & Sheline, Y. I. (2018). Cognitive-behavioral therapy is associated with enhanced cognitive control network activity in major depression and posttraumatic stress disorder. Biological psychiatry: cognitive neuroscience and neuroimaging3(4), 311-319. DOI: 
10.1016/j.bpsc.2017.12.006

The author adopted the experimental research to determine how the CBT is linked to the improved cognitive control network activity with the major depression and the PTSD. The authors are employed at the department of psychological sciences, the center of neuromodulation in depression, and the department of biostatics among others. This is an indication that research is based on the expertise and skills possessed by the authors. The study outcome shows the dimensional abnormal in the process of activating the cognitive control regions that were linked to the depressive signs. The activation of the cognitive control regions was the same for patients with Major depressive disorder and PTSD under CBT. The study is important since it shows the role the in the treatment of mental conditions like PTSD.

Salomonsson, S., Santoft, F., Lindsäter, E., Ejeby, K., Ingvar, M., Öst, L. G., … & Hedman-Lagerlöf, E. (2020). Predictors of outcome in guided self-help cognitive behavioral therapy for common mental disorders in primary care. Cognitive Behaviour Therapy49(6), 455-474. DOI: 10.1080/16506073.2019.1669701

The study was aimed at investigating the predictors of the outcome for the guided self-help CBT for the clients with widely recognized mental illnesses within the primary care. Experimental research work was adopted. The analyses were performed utilizing logical and linear regression. The study reveals that the variables such as patient adherence to the treatment plan and the patient clinician’s estimation of the treatment response affect the overall outcome. The study is important as it reveals that the rating of high quality of life leads to remission and drop in the depression and an increased level of reliance to change. The authors are employees at the department of the centers for psychiatry and the department of neurobiology and neuroradiology among others. This is an indication of the qualification of the researchers in this area hence confirming the importance of the article when used to perform further research on the field of mental illness.

Cervin, M., Storch, E. A., Piacentini, J., Birmaher, B., Compton, S. N., Albano, A. M., … & Kendall, P. C. (2020). Symptom‐specific effects of cognitive‐behavioral therapy, sertraline, and their combination in a large randomized controlled trial of pediatric anxiety disorders. Journal of Child Psychology and Psychiatry61(4), 492-502. DOI: 
10.1111/jcpp.13124

The article is based on the use of the network intervention analysis (NIA) to analyze data collected from the RCT of pediatric anxiety disorder. The study outcomes show that all active treatments lead the positive outcomes. The most pronounced effect ranged from avoidance and psychological distress. Therefore, the combination of the CBT and sertraline appear to be having mechanism of action on psychological distress. The study is important for use since it reveals the effectiveness of a combined CBT and medication process. The information presented in the article is reliable since the authors have qualifications and professionals in the departments of psychiatry, department of clinical sciences, and the department of psychiatry and behavioral sciences.

Scholarly Research Log

Scholarly Research Log Note: This is just one possible way to set up a research log. Feel free to adapt this in a way that works for you.
Article or Book citation DOI (if applicable) Hyperlink to Resource
(if applicable)
Peer Review? Theory/Model Method(s) Measurement or test used Research Variable 1 Research Variable 2 Research Variable 3 Major Findings Additional Findings Good Quotes Questions Other Notes
Cited, F. & Prototype, P. (2018). To plagiarize is to steal ideas: Students’ knowledge about citing. New Publisher Press. https://campus.capella.edu/academic-honesty-and-apa/avoiding-plagiarism No Kohlberg’s theory of moral development qualitative x x The majority of students agreed it was wrong to use someone else’s words without citing that person. P. 167 – “All but one of the twelve interviewed graduate students understood they were supposed to cite their sources….” Describes graduate students’ attitudes about plagiarism and the likelihood they have plagiarized others’ works themselves.
Nakao, M., Shirotsuki, K., & Sugaya, N. (2021). Cognitive-behavioral therapy for management of mental health and stress-related disorders: Recent advances in techniques and technologies. BioPsychoSocial medicine, 15(1), 1-4. Doi: 10.1186/s13030-021-00219-w Doi: 10.1186/s13030-021-00219-w https://wwhttps://bpsmedicine.biomedcentral.com/track/pdf/10.1186/s13030-021-00219-w.pdfw.ncbi.nlm.nih.gov/pmc/articles/PMC8489050/ Yes Learning theory principles, such as classical and operant conditioning, to clinical problems Quantitative None Cognitive-behavioral therapy mental health Stress related disorders CBT iss effective for a variety of mental problems Mental and physical problems can likely be managed effectively with online CBT or self-help CBT using a mobile app “CBT should be applied with care, considering their cost-effectiveness and applicability” Does CBT effective for other population with mental disorder and low income based on the cost and the applicability of the mobile application to promote CBT? The use of the CBT can be in the form of online platform or self-help CBT.
David, D., Cristea, I., & Hofmann, S. G. (2018). Why cognitive behavioral therapy is the current gold standard of psychotherapy. Frontiers in psychiatry, 9, 4. Doi: 10.3389/fpsyt.2018.00004 Doi: 10.3389/fpsyt.2018.00004 https://www.ncbi.nlm.nih.gov/pmc/articles/PMC5797481/ No. not specified Concerning theory/mechanisms of change Nnot mentnioned None Cognitive-behavioral therapy Gold stanard therapy N/A CBT is the gold standard in the psychotherapy field, being included in the major clinical guidelines based on its rigorous empirical basis CBT is an evolving psychotherapy based on research (i.e., a progressive research program Although CBT is efficacious/effective, there is still room for improvement Why Cognitive Behavioral Therapy Is the Current Gold Standard of Psychotherapy? CBT is gradually moving the field toward an integrative scientific psychotherapy.
Carpenter, J. K., Andrews, L. A., Witcraft, S. M., Powers, M. B., Smits, J. A., & Hofmann, S. G. (2018). Cognitive-behavioral therapy for anxiety and related disorders: A meta?analysis of randomized placebo?controlled trials. Depression and anxiety, 35(6), 502-514. DOI: 10.1002/da.22728 DOI: 10.1002/da.22728 http://europepmc.org/backend/ptpmcrender.fcgi?accid=PMC5992015&blobtype=pdf Yes Not mentioned A meta-analysis of randomized placebo-controlled trials Percentages and probability Cognitive-behavioral therapy Anxiety-associated disorders NA CBT is a moderately efficacious treatment for anxiety disorders when compared to placebo. Are required for the treatment of obsessive compulsive disorder (OCD), panic disorder (PD), posttraumatic stress disorder (PTSD), or social anxiety disorder (SAD) Interventions primarily using exposure strategies has larger effect sizes than those using cognitive or cognitive and behavioral techniques, Is CBT effective for the anxiety-associated disorders There is effictiveness of cognitive behavioral therapy (CBT) for anxiety-related disorders based
He, H. L., Zhang, M., Gu, C. Z., Xue, R. R., Liu, H. X., Gao, C. F., & Duan, H. F. (2019). Effect of cognitive behavioral therapy on improving the cognitive function in major and minor depression. The Journal of Nervous and Mental Disease, 207(4), 232-238. DOI: 10.1097/NMD.0000000000000954 DOI: 10.1097/NMD.0000000000000954 https://pubmed.ncbi.nlm.nih.gov/30865075/ none Placebo-controlled single-blind parallel-group randomized controlled trial Use of the percentges and the t-test for probability Cognitive-behavioral therapy Cognitive function in minor and major depression Depression CBT significantly alleviated depressive symptoms of MiD and MaD at 12 weeks CBT significantly promotes more cognitive function of MiD and partial cognitive function of MaD The effectiveness of CBT is different on improving the cognitive function in MiD and MaD. What is the effect of Cognitive Behavioral Therapy on Improving the Cognitive Function in Major and Minor Depression? The CBT plays a role in impacting on the cognitive role for individuals under minor and major depression treatment
Gautam, M., Tripathi, A., Deshmukh, D., & Gaur, M. (2020). Cognitive behavioral therapy for depression. Indian journal of psychiatry, 62(Suppl 2), S223. Doi: 10.4103/psychiatry.IndianJPsychiatry_772_19 doi: 10.4103/psychiatry.IndianJPsychiatry_772_19 https://www.ncbi.nlm.nih.gov/pmc/articles/PMC7001356/ No None None None Cognitive-behavioral therapy Depression NA CBT is used with other medications to help in the treatment of depression since its management is challenging. Severe depression associated with psychosis or suicidal thoughts are difficult to manage A combination of both psychotherapy and medication leads to successful treatment of depression What is the impact of CBT on depression? Depressive disorders is cmmon in people of all ages internationally.
von Brachel, R., Hirschfeld, G., Berner, A., Willutzki, U., Teismann, T., Cwik, J. C., … & Margraf, J. (2019). Long-term effectiveness of cognitive behavioral therapy in routine outpatient care: a 5-to 20-year follow-up study. Psychotherapy and psychosomatics, 88(4), 225-235. DOI: 10.1159/000500188 DOI: 10.1159/000500188 https://pubmed.ncbi.nlm.nih.gov/31121580/ Yes None Literature describes follow-up data of randomized-controlled trials Brief-Symptom Inventory (BSI) and the Beck Depression Inventory (BDI) and the t-test for probablity Long-term effectiveness of CBT Routine outpatient care NA The results point to the long-term effectiveness of CBT under routine conditions such as depression, anxiety-, eating- or somatoform disorders 29% (BDI) and 17% (BSI) experienced clinically significant change at posttreatment It is noteworthy that the results at follow-up were even better than at posttreatment, indicating further improvement. What is the long-term effectivness of the CBT in routine outpatient care. CBT helps in the management of various mental illnesses
Wright, J. H., Owen, J. J., Richards, D., Eells, T. D., Richardson, T., Brown, G. K., … & Thase, M. E. (2019). Computer-assisted cognitive-behavior therapy for depression: a systematic review and meta-analysis. The Journal of clinical psychiatry, 80(2), 3573. DOI: 10.4088/JCP.18r12188 DOI: 10.4088/JCP.18r12188 https://pubmed.ncbi.nlm.nih.gov/30900849/ Yes None Randomized, controlled trials of computer-assisted cognitive-behavior therapy for depression” and “randomized, controlled trials of mobile apps for cognitive-behavior therapy of depression.” Mean effect size Computer-Assisted Cognitive-Behavior Therapy Depresion NA Computer-assisted CBT with some support from the provider is effective on the depressive symptoms There was moderate large effect of the overall mean effect size of the computer associated CBT. Future research should focus on improving the implementation of Computer-assisted CBT What is the effect of the computer-assisted CBT for depression? The computer-assisted CBT can be used to support patientns overcome the symptoms of depression
Yang, Z., Oathes, D. J., Linn, K. A., Bruce, S. E., Satterthwaite, T. D., Cook, P. A., … & Sheline, Y. I. (2018). Cognitive behavioral therapy is associated with enhanced cognitive control network activity in major depression and posttraumatic stress disorder. Biological psychiatry: cognitive neuroscience and neuroimaging, 3(4), 311-319. DOI: 10.1016/j.bpsc.2017.12.006 DOI: 10.1016/j.bpsc.2017.12.006 https://www.nature.com/articles/s41380-018-0201-7.pdf No None Experimental work Montgomery-Åsberg Depression Rating Scale scores Cognitive Behavioral Therapy Cognitve Control Network activity Major depression and PTSD Dimensional abnormalities in the activation of cognitive control regions linked to symptoms of depression Treatment using CBT leads to the activation of cognitive control regions was similarly increased in both MDD and PTSD The study outomes accord with the Research Domain Criteria conceptualization of mental disorders What is the impact of CBT control network activity in MDD and PTSD. The study implicate improved cognitive control activation as a transdiagnostic mechanism for CBT treatment outcome.
Salomonsson, S., Santoft, F., Lindsäter, E., Ejeby, K., Ingvar, M., Öst, L. G., … & Hedman-Lagerlöf, E. (2020). Predictors of outcome in guided self-help cognitive behavioural therapy for common mental disorders in primary care. Cognitive Behaviour Therapy, 49(6), 455-474. DOI: 10.1080/16506073.2019.1669701 DOI: 10.1080/16506073.2019.1669701 No None Experimental work and Analyses were conducted using logistic and linear regression Analyses were conducted using logistic and linear regression Patient adherence to treatment Patients’ and clinicians’ estimation of treatment response, CBT Higher educational level predicted remission, higher quality of life ratings predicted remission and decreased depression, and higher age at onset predicted reliable change. Patient adherence to treatment and patients’ and clinicians’ estimation of treatment response, were all related to outcome More large-scale studies are needed, but the present study points at the importance of therapy-related variables such as m What are the predictors of the outcome in the presence of a guided self-help cognitive behaviroal therapy for mental disoders? More large-scale studies are needed, but the present study points at the importance of therapy-related variables such as monitoring and supporting treatment adherence for an increased chance of remissio
Cervin, M., Storch, E. A., Piacentini, J., Birmaher, B., Compton, S. N., Albano, A. M., … & Kendall, P. C. (2020). Symptom?specific effects of cognitive?behavioral therapy, sertraline, and their combination in a large randomized controlled trial of pediatric anxiety disorders. Journal of Child Psychology and Psychiatry, 61(4), 492-502. DOI: 10.1111/jcpp.13124 DOI: 10.1111/jcpp.13124 NO None The network intervention analysis (NIA) to amnalyze data from the largest randomized controlled treatment trial of pediatric anxiety disorder None Sysmptom-specific impacts of CBT Sertraline Pediatric anxety disorder All active treatments showed beneficial effects when compared to placebo, and NIA identified that these effects were exerted similarly across treatments and primarily through a reduction of psychological distress, family interference, and avoidance. CBT and sertraline may have differential mechanisms of action in relation to psychological distress Psychological distress and avoidance should remain key treatment focuses because of their central roles in the disorder network What is the effects of symptom-specific effects of CBT, sertraline, and their combinarion on RCT of pediatric anxiety disorder The findings inform and promote developing more effective interventions.

https://wwhttps/bpsmedicine.biomedcentral.com/track/pdf/10.1186/s13030-021-00219-w.pdfw.ncbi.nlm.nih.gov/pmc/articles/PMC8489050/
http://europepmc.org/backend/ptpmcrender.fcgi?accid=PMC5992015&blobtype=pdf
https://www.nature.com/articles/s41380-018-0201-7.pdf

Database Search Log

Database Search Log Instructions: Use this log to keep track of which databases and searches you have already tried.
Date Database Name Keywords Limiters/Filters Results Link to Search (if available) Notes
5/14/20 CINAHL Complete Line 1: chronic pain
Line 2: prevention or control or management
Line 3: older people or older adults or elderly
Removed check from Full Text box.
Limited to last 5 years.
Limited first 2 lines to AB Abstract.
287 results. Saved 17 to RefWorks http://library.capella.edu/login?url=http://search.ebscohost.com/login.aspx?direct=true&db=ccm&bquery=AB+chronic+pain+AND+AB+(+prevention+or+control+or+management+)+AND+(+older+people+or+older+adults+or+elderly+)&cli0=RV&clv0=Y&cli1=DT1&clv1=201601-202012&type=1&searchMode=Standard&site=ehost-live&scope=site (Example) Note: To get a persistent link to a search in Ebsco databases, click the Share link above the top result on the right side of the page. The persistent link to the search is the last thing in the dropdown menu.
5/15/20 ProQuest Central Line 1: online education OR online learning Line 2: “instructional design” Removed check from Full Text box.
Limited to last 5 years.
Limited both lines to Anywhere except full text–NOFT.
609 results. Saved 26 to RefWorks. https://capellauniversity.libguides.com/PQ_MedicalLibrary/CreateAccount (Example) Note: If you want a persistent link for a ProQuest database search, you have to create a “My

Literature Review

ANNOTATED BIBLIOGRAPHY 2






Annotated Bibliography

Rebecca Faino

Capella University

Integrative Project Masters in Psy

Howard Fero

April 30, 2022


Mental illness is among healthcare issues that affect the well-being of individuals in the present society. Mental illness is common in all age groups and ethnic groupings. The effective management of mental illness requires both pharmacological and non-pharmacological interventions. The treatment approaches are targeted at reducing the symptoms and improvement on the behaviors of the affected individuals. Various medications such as antidepressants are used for the management of patients. Also, the psychotherapy interventions such as family therapy, group therapy, and cognitive-behavioral therapy (CBT) help address the issue. For this discussion, the focus is on the presentation of annotated bibliography on the role of cognitive-behavioral therapy in the management of mental illness.


Nakao, M., Shirotsuki, K., & Sugaya, N. (2021). Cognitive-behavioral therapy for the management of mental health and stress-related disorders: Recent advances in techniques and technologies. BioPsychoSocial medicine15(1), 1-4. Doi: 10.1186/s13030-021-00219-w

The authors of the article aimed at determining the effectiveness of the CBT in stressful situations among the clinical and the general population and identifying the advancement in the CBT-related methods. The authors of this article are qualified in the areas of study. They are employed in the department of Psychosomatic Medicine, graduate from the school of the human and social sciences, and a member of the unit of public health and preventive medicine. A literature review method was adopted to search for the studies that were performed from 1987 to 2021 and this led to the identification of the 345 articles that relates to biopsychosocial medicine. The problem of focus in this article is the mental health and stress-associated disorders. The results from this study show that CBT was suitable for various categories of mental problems. The study is, therefore, important for the selected issue of mental illness as it reveals the role of CBT in the successful management of mental and physical issues. The use of the online CBT and the self-help CBT through the use of the mobile applications. The article is relevant since it was recently published by qualified authors.


David, D., Cristea, I., & Hofmann, S. G. (2018). Why cognitive behavioral therapy is the current gold standard of psychotherapy. Frontiers in psychiatry9, 4.  Doi: 10.3389/fpsyt.2018.00004

The authors aimed at looking at the reasons why CBT is considered the present gold standard of psychotherapy. The authors of the articles have qualifications for working in the department of clinical psychology and psychotherapy, the department of the health sciences and policy, and the department of the psychological and brain sciences. The authors failed to give a clear illustration of the method of the study. The findings of the study show that CBT is promoted as one of the effective approaches to dealing with mental illness. It is recognized by the international guideline for psychotherapy treatments and hence can be used as the first-line treatment approach. Even though the authors of the article are qualified in terms of their professionals, the study lacks a clear method of study thus making it hard t decide on using it to support the efforts towards dealing with mental issues.

Carpenter, J. K., Andrews, L. A., Witcraft, S. M., Powers, M. B., Smits, J. A., & Hofmann, S. G. (2018). Cognitive-behavioral therapy for anxiety and related disorders: A meta‐analysis of randomized placebo‐controlled trials. Depression and anxiety35(6), 502-514. DOI: 10.1002/da.22728

The authors focused on examining the effectiveness of CBT for anxiety-associated illness using randomized placebo-controlled trials. The study method involved a literature review using 41 studies with patients diagnosed with various disorders like obsessive-compulsive disorder and general anxiety disorder among others. The authors are employed in the department of

psychological and brain sciences, the department of psychology and institute for mental health research, and the department of psychology among others. The findings of the study show that CBT is a moderately effective in the treatment approach of anxiety disorders than placebo. Therefore, this study is relevant based on the method adopted and its recent publication. Therefore, the interventions such as CBT can be used to address mental illnesses like post-traumatic stress disorder and panic disorder.

He, H. L., Zhang, M., Gu, C. Z., Xue, R. R., Liu, H. X., Gao, C. F., & Duan, H. F. (2019). Effect of cognitive-behavioral therapy on improving the cognitive function in major and minor depression. The Journal of Nervous and Mental Disease, 207(4), 232-238. DOI: 10.1097/NMD.0000000000000954

The article was aimed at investigating the effectiveness of the CBT on the improvement of the cognitive functions in minor depression and major depression. The author adopted the placebo-controlled single blond parallel-group randomized controlled trial. Looking at the affiliation of the authors, they are employed in the psychiatric department and department of psychiatry rehabilitation. This shows that the authors have specific qualifications in the area. The findings of the study show that CBT helps in the alleviation of the depressive symptoms of minor depression and major depression. The article is relevant and important to deal with the issue of mental disorders. Therefore, it can be advocated for or promoted to help in dealing with minor depression and preventing it from occurring. CBT is helpful in the promotion of an increased level of cognitive function.

Gautam, M., Tripathi, A., Deshmukh, D., & Gaur, M. (2020). Cognitive-behavioral therapy for depression. Indian journal of psychiatry62(Suppl 2), S223. Doi: 10.4103/psychiatry.IndianJPsychiatry_772_19


The authors focused on the study of cognitive-behavioral therapy for depression. The article provided is not based on a specific method. The authors are employed as consultant psychiatrists, the department of Psychiatry, the Department of MDG medical college, and consultant psychologists. The evidence from the study shows that CBT helps in the reduction of depressive symptoms as an independent treatment or when combined with other medication, helps in the modification of the underlying schemas or beliefs that assist in the maintenance of the depression, and helping in addressing different psychosocial issues. The information presented in the article is helpful for the research, however, it can be questioned since the authors failed to give clear data about the method of study adopted.

von Brachel, R., Hirschfeld, G., Berner, A., Willutzki, U., Teismann, T., Cwik, J. C., … & Margraf, J. (2019). Long-term effectiveness of cognitive-behavioral therapy in routine outpatient care: a 5-to 20-year follow-up study. Psychotherapy and psychosomatics88(4), 225-235. DOI: 10.1159/000500188

The authors focused on the investigation of the psychological functioning of selected outpatients who were on CBT for various mental disorders. The authors are employed at the mental health research and treatment center, the faculty of business and health, the faculty of psychology and psychotherapy, and the mental health research and treatment center. Based on these qualifications, the authors had the knowledge and information related to the information presented in the article. The author adopted the pre and post-treatment and from the pre-treatment to follow-up evaluation. The study outcomes show the long-term effectiveness of the CBT approach in addressing various groups of mental illnesses like depression, anxiety, and treating disorders. The study is important and can be adopted to tackle the presented issue of mental illness as it shows the effectiveness of the CBT.


Wright, J. H., Owen, J. J., Richards, D., Eells, T. D., Richardson, T., Brown, G. K., … & Thase, M. E. (2019). Computer-assisted cognitive-behavior therapy for depression: a systematic review and meta-analysis. The Journal of clinical psychiatry80(2), 3573. DOI: 10.4088/JCP.18r12188

The authors focused on evaluating the effectiveness of the computer-assisted forms of CBT for the major depressive disorder (MDD) ad examining the role played by the clinical support. The authors derived the data from databases such as Scopus with a focus on the RCT of the computer-assisted CBT for depression and the RCT of the mobile applications for CBT of depression. The outcome of the study shows that computer-assisted CBT with some support from the provider is effective in depressive symptoms. The study is, therefore, important for the selected issues since it shows the computer-assisted CBT approach as one of the interventions that can be adopted.

Yang, Z., Oathes, D. J., Linn, K. A., Bruce, S. E., Satterthwaite, T. D., Cook, P. A., … & Sheline, Y. I. (2018). Cognitive-behavioral therapy is associated with enhanced cognitive control network activity in major depression and posttraumatic stress disorder. Biological psychiatry: cognitive neuroscience and neuroimaging3(4), 311-319. DOI: 
10.1016/j.bpsc.2017.12.006

The author adopted the experimental research to determine how the CBT is linked to the improved cognitive control network activity with the major depression and the PTSD. The authors are employed at the department of psychological sciences, the center of neuromodulation in depression, and the department of biostatics among others. This is an indication that research is based on the expertise and skills possessed by the authors. The study outcome shows the dimensional abnormal in the process of activating the cognitive control regions that were linked to the depressive signs. The activation of the cognitive control regions was the same for patients with Major depressive disorder and PTSD under CBT. The study is important since it shows the role the in the treatment of mental conditions like PTSD.

Salomonsson, S., Santoft, F., Lindsäter, E., Ejeby, K., Ingvar, M., Öst, L. G., … & Hedman-Lagerlöf, E. (2020). Predictors of outcome in guided self-help cognitive behavioral therapy for common mental disorders in primary care. Cognitive Behaviour Therapy49(6), 455-474. DOI: 10.1080/16506073.2019.1669701

The study was aimed at investigating the predictors of the outcome for the guided self-help CBT for the clients with widely recognized mental illnesses within the primary care. Experimental research work was adopted. The analyses were performed utilizing logical and linear regression. The study reveals that the variables such as patient adherence to the treatment plan and the patient clinician’s estimation of the treatment response affect the overall outcome. The study is important as it reveals that the rating of high quality of life leads to remission and drop in the depression and an increased level of reliance to change. The authors are employees at the department of the centers for psychiatry and the department of neurobiology and neuroradiology among others. This is an indication of the qualification of the researchers in this area hence confirming the importance of the article when used to perform further research on the field of mental illness.

Cervin, M., Storch, E. A., Piacentini, J., Birmaher, B., Compton, S. N., Albano, A. M., … & Kendall, P. C. (2020). Symptom‐specific effects of cognitive‐behavioral therapy, sertraline, and their combination in a large randomized controlled trial of pediatric anxiety disorders. Journal of Child Psychology and Psychiatry61(4), 492-502. DOI: 
10.1111/jcpp.13124

The article is based on the use of the network intervention analysis (NIA) to analyze data collected from the RCT of pediatric anxiety disorder. The study outcomes show that all active treatments lead the positive outcomes. The most pronounced effect ranged from avoidance and psychological distress. Therefore, the combination of the CBT and sertraline appear to be having mechanism of action on psychological distress. The study is important for use since it reveals the effectiveness of a combined CBT and medication process. The information presented in the article is reliable since the authors have qualifications and professionals in the departments of psychiatry, department of clinical sciences, and the department of psychiatry and behavioral sciences.

Scholarly Research Log

Scholarly Research Log Note: This is just one possible way to set up a research log. Feel free to adapt this in a way that works for you.
Article or Book citation DOI (if applicable) Hyperlink to Resource
(if applicable)
Peer Review? Theory/Model Method(s) Measurement or test used Research Variable 1 Research Variable 2 Research Variable 3 Major Findings Additional Findings Good Quotes Questions Other Notes
Cited, F. & Prototype, P. (2018). To plagiarize is to steal ideas: Students’ knowledge about citing. New Publisher Press. https://campus.capella.edu/academic-honesty-and-apa/avoiding-plagiarism No Kohlberg’s theory of moral development qualitative x x The majority of students agreed it was wrong to use someone else’s words without citing that person. P. 167 – “All but one of the twelve interviewed graduate students understood they were supposed to cite their sources….” Describes graduate students’ attitudes about plagiarism and the likelihood they have plagiarized others’ works themselves.
Nakao, M., Shirotsuki, K., & Sugaya, N. (2021). Cognitive-behavioral therapy for management of mental health and stress-related disorders: Recent advances in techniques and technologies. BioPsychoSocial medicine, 15(1), 1-4. Doi: 10.1186/s13030-021-00219-w Doi: 10.1186/s13030-021-00219-w https://wwhttps://bpsmedicine.biomedcentral.com/track/pdf/10.1186/s13030-021-00219-w.pdfw.ncbi.nlm.nih.gov/pmc/articles/PMC8489050/ Yes Learning theory principles, such as classical and operant conditioning, to clinical problems Quantitative None Cognitive-behavioral therapy mental health Stress related disorders CBT iss effective for a variety of mental problems Mental and physical problems can likely be managed effectively with online CBT or self-help CBT using a mobile app “CBT should be applied with care, considering their cost-effectiveness and applicability” Does CBT effective for other population with mental disorder and low income based on the cost and the applicability of the mobile application to promote CBT? The use of the CBT can be in the form of online platform or self-help CBT.
David, D., Cristea, I., & Hofmann, S. G. (2018). Why cognitive behavioral therapy is the current gold standard of psychotherapy. Frontiers in psychiatry, 9, 4. Doi: 10.3389/fpsyt.2018.00004 Doi: 10.3389/fpsyt.2018.00004 https://www.ncbi.nlm.nih.gov/pmc/articles/PMC5797481/ No. not specified Concerning theory/mechanisms of change Nnot mentnioned None Cognitive-behavioral therapy Gold stanard therapy N/A CBT is the gold standard in the psychotherapy field, being included in the major clinical guidelines based on its rigorous empirical basis CBT is an evolving psychotherapy based on research (i.e., a progressive research program Although CBT is efficacious/effective, there is still room for improvement Why Cognitive Behavioral Therapy Is the Current Gold Standard of Psychotherapy? CBT is gradually moving the field toward an integrative scientific psychotherapy.
Carpenter, J. K., Andrews, L. A., Witcraft, S. M., Powers, M. B., Smits, J. A., & Hofmann, S. G. (2018). Cognitive-behavioral therapy for anxiety and related disorders: A meta?analysis of randomized placebo?controlled trials. Depression and anxiety, 35(6), 502-514. DOI: 10.1002/da.22728 DOI: 10.1002/da.22728 http://europepmc.org/backend/ptpmcrender.fcgi?accid=PMC5992015&blobtype=pdf Yes Not mentioned A meta-analysis of randomized placebo-controlled trials Percentages and probability Cognitive-behavioral therapy Anxiety-associated disorders NA CBT is a moderately efficacious treatment for anxiety disorders when compared to placebo. Are required for the treatment of obsessive compulsive disorder (OCD), panic disorder (PD), posttraumatic stress disorder (PTSD), or social anxiety disorder (SAD) Interventions primarily using exposure strategies has larger effect sizes than those using cognitive or cognitive and behavioral techniques, Is CBT effective for the anxiety-associated disorders There is effictiveness of cognitive behavioral therapy (CBT) for anxiety-related disorders based
He, H. L., Zhang, M., Gu, C. Z., Xue, R. R., Liu, H. X., Gao, C. F., & Duan, H. F. (2019). Effect of cognitive behavioral therapy on improving the cognitive function in major and minor depression. The Journal of Nervous and Mental Disease, 207(4), 232-238. DOI: 10.1097/NMD.0000000000000954 DOI: 10.1097/NMD.0000000000000954 https://pubmed.ncbi.nlm.nih.gov/30865075/ none Placebo-controlled single-blind parallel-group randomized controlled trial Use of the percentges and the t-test for probability Cognitive-behavioral therapy Cognitive function in minor and major depression Depression CBT significantly alleviated depressive symptoms of MiD and MaD at 12 weeks CBT significantly promotes more cognitive function of MiD and partial cognitive function of MaD The effectiveness of CBT is different on improving the cognitive function in MiD and MaD. What is the effect of Cognitive Behavioral Therapy on Improving the Cognitive Function in Major and Minor Depression? The CBT plays a role in impacting on the cognitive role for individuals under minor and major depression treatment
Gautam, M., Tripathi, A., Deshmukh, D., & Gaur, M. (2020). Cognitive behavioral therapy for depression. Indian journal of psychiatry, 62(Suppl 2), S223. Doi: 10.4103/psychiatry.IndianJPsychiatry_772_19 doi: 10.4103/psychiatry.IndianJPsychiatry_772_19 https://www.ncbi.nlm.nih.gov/pmc/articles/PMC7001356/ No None None None Cognitive-behavioral therapy Depression NA CBT is used with other medications to help in the treatment of depression since its management is challenging. Severe depression associated with psychosis or suicidal thoughts are difficult to manage A combination of both psychotherapy and medication leads to successful treatment of depression What is the impact of CBT on depression? Depressive disorders is cmmon in people of all ages internationally.
von Brachel, R., Hirschfeld, G., Berner, A., Willutzki, U., Teismann, T., Cwik, J. C., … & Margraf, J. (2019). Long-term effectiveness of cognitive behavioral therapy in routine outpatient care: a 5-to 20-year follow-up study. Psychotherapy and psychosomatics, 88(4), 225-235. DOI: 10.1159/000500188 DOI: 10.1159/000500188 https://pubmed.ncbi.nlm.nih.gov/31121580/ Yes None Literature describes follow-up data of randomized-controlled trials Brief-Symptom Inventory (BSI) and the Beck Depression Inventory (BDI) and the t-test for probablity Long-term effectiveness of CBT Routine outpatient care NA The results point to the long-term effectiveness of CBT under routine conditions such as depression, anxiety-, eating- or somatoform disorders 29% (BDI) and 17% (BSI) experienced clinically significant change at posttreatment It is noteworthy that the results at follow-up were even better than at posttreatment, indicating further improvement. What is the long-term effectivness of the CBT in routine outpatient care. CBT helps in the management of various mental illnesses
Wright, J. H., Owen, J. J., Richards, D., Eells, T. D., Richardson, T., Brown, G. K., … & Thase, M. E. (2019). Computer-assisted cognitive-behavior therapy for depression: a systematic review and meta-analysis. The Journal of clinical psychiatry, 80(2), 3573. DOI: 10.4088/JCP.18r12188 DOI: 10.4088/JCP.18r12188 https://pubmed.ncbi.nlm.nih.gov/30900849/ Yes None Randomized, controlled trials of computer-assisted cognitive-behavior therapy for depression” and “randomized, controlled trials of mobile apps for cognitive-behavior therapy of depression.” Mean effect size Computer-Assisted Cognitive-Behavior Therapy Depresion NA Computer-assisted CBT with some support from the provider is effective on the depressive symptoms There was moderate large effect of the overall mean effect size of the computer associated CBT. Future research should focus on improving the implementation of Computer-assisted CBT What is the effect of the computer-assisted CBT for depression? The computer-assisted CBT can be used to support patientns overcome the symptoms of depression
Yang, Z., Oathes, D. J., Linn, K. A., Bruce, S. E., Satterthwaite, T. D., Cook, P. A., … & Sheline, Y. I. (2018). Cognitive behavioral therapy is associated with enhanced cognitive control network activity in major depression and posttraumatic stress disorder. Biological psychiatry: cognitive neuroscience and neuroimaging, 3(4), 311-319. DOI: 10.1016/j.bpsc.2017.12.006 DOI: 10.1016/j.bpsc.2017.12.006 https://www.nature.com/articles/s41380-018-0201-7.pdf No None Experimental work Montgomery-Åsberg Depression Rating Scale scores Cognitive Behavioral Therapy Cognitve Control Network activity Major depression and PTSD Dimensional abnormalities in the activation of cognitive control regions linked to symptoms of depression Treatment using CBT leads to the activation of cognitive control regions was similarly increased in both MDD and PTSD The study outomes accord with the Research Domain Criteria conceptualization of mental disorders What is the impact of CBT control network activity in MDD and PTSD. The study implicate improved cognitive control activation as a transdiagnostic mechanism for CBT treatment outcome.
Salomonsson, S., Santoft, F., Lindsäter, E., Ejeby, K., Ingvar, M., Öst, L. G., … & Hedman-Lagerlöf, E. (2020). Predictors of outcome in guided self-help cognitive behavioural therapy for common mental disorders in primary care. Cognitive Behaviour Therapy, 49(6), 455-474. DOI: 10.1080/16506073.2019.1669701 DOI: 10.1080/16506073.2019.1669701 No None Experimental work and Analyses were conducted using logistic and linear regression Analyses were conducted using logistic and linear regression Patient adherence to treatment Patients’ and clinicians’ estimation of treatment response, CBT Higher educational level predicted remission, higher quality of life ratings predicted remission and decreased depression, and higher age at onset predicted reliable change. Patient adherence to treatment and patients’ and clinicians’ estimation of treatment response, were all related to outcome More large-scale studies are needed, but the present study points at the importance of therapy-related variables such as m What are the predictors of the outcome in the presence of a guided self-help cognitive behaviroal therapy for mental disoders? More large-scale studies are needed, but the present study points at the importance of therapy-related variables such as monitoring and supporting treatment adherence for an increased chance of remissio
Cervin, M., Storch, E. A., Piacentini, J., Birmaher, B., Compton, S. N., Albano, A. M., … & Kendall, P. C. (2020). Symptom?specific effects of cognitive?behavioral therapy, sertraline, and their combination in a large randomized controlled trial of pediatric anxiety disorders. Journal of Child Psychology and Psychiatry, 61(4), 492-502. DOI: 10.1111/jcpp.13124 DOI: 10.1111/jcpp.13124 NO None The network intervention analysis (NIA) to amnalyze data from the largest randomized controlled treatment trial of pediatric anxiety disorder None Sysmptom-specific impacts of CBT Sertraline Pediatric anxety disorder All active treatments showed beneficial effects when compared to placebo, and NIA identified that these effects were exerted similarly across treatments and primarily through a reduction of psychological distress, family interference, and avoidance. CBT and sertraline may have differential mechanisms of action in relation to psychological distress Psychological distress and avoidance should remain key treatment focuses because of their central roles in the disorder network What is the effects of symptom-specific effects of CBT, sertraline, and their combinarion on RCT of pediatric anxiety disorder The findings inform and promote developing more effective interventions.

https://wwhttps/bpsmedicine.biomedcentral.com/track/pdf/10.1186/s13030-021-00219-w.pdfw.ncbi.nlm.nih.gov/pmc/articles/PMC8489050/
http://europepmc.org/backend/ptpmcrender.fcgi?accid=PMC5992015&blobtype=pdf
https://www.nature.com/articles/s41380-018-0201-7.pdf

Database Search Log

Database Search Log Instructions: Use this log to keep track of which databases and searches you have already tried.
Date Database Name Keywords Limiters/Filters Results Link to Search (if available) Notes
5/14/20 CINAHL Complete Line 1: chronic pain
Line 2: prevention or control or management
Line 3: older people or older adults or elderly
Removed check from Full Text box.
Limited to last 5 years.
Limited first 2 lines to AB Abstract.
287 results. Saved 17 to RefWorks http://library.capella.edu/login?url=http://search.ebscohost.com/login.aspx?direct=true&db=ccm&bquery=AB+chronic+pain+AND+AB+(+prevention+or+control+or+management+)+AND+(+older+people+or+older+adults+or+elderly+)&cli0=RV&clv0=Y&cli1=DT1&clv1=201601-202012&type=1&searchMode=Standard&site=ehost-live&scope=site (Example) Note: To get a persistent link to a search in Ebsco databases, click the Share link above the top result on the right side of the page. The persistent link to the search is the last thing in the dropdown menu.
5/15/20 ProQuest Central Line 1: online education OR online learning Line 2: “instructional design” Removed check from Full Text box.
Limited to last 5 years.
Limited both lines to Anywhere except full text–NOFT.
609 results. Saved 26 to RefWorks. https://capellauniversity.libguides.com/PQ_MedicalLibrary/CreateAccount (Example) Note: If you want a persistent link for a ProQuest database search, you have to create a “My