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Self-help Books for Social Anxiety

Primary Purpose

Social Anxiety

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Mindfulness and Acceptance Workbook for Social Anxiety and Shyness
The Shyness and Social Anxiety Workbook
Sponsored by
Utah State University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Social Anxiety

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Age 18 or older
  • Enrolled at Utah State University
  • Have not participated in other self-help studies run by the USU CBS Lab
  • Interested in using self-help book for social anxiety
  • Scoring at least a 6 on the Mini Social Phobia Inventory (Mini-SPIN), a validated social anxiety screening measure

Exclusion Criteria:

  • Exclusion criteria mirror inclusion criteria: below the age of 18, not a student at Utah State University, have participated in previous self-help studies run by the CBS Lab, not interested in using a self-help book for social anxiety, or scoring a 5 or lower on the Mini-SPIN.

Sites / Locations

  • Utah State University

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

ACT self-help book condition

CBT self-help book condition

Arm Description

Participants in this condition will be assigned to read The Mindfulness and Acceptance Workbook for Social Anxiety and Shyness by Fleming and Kocovski (2013), a self-help book based on acceptance and commitment therapy.

Participants in this condition will be assigned to read The Shyness and Social Anxiety Workbook by Antony and Swinson (2008), a self-help book based on cognitive-behavioral therapy for social anxiety.

Outcomes

Primary Outcome Measures

Liebowitz Social Anxiety Scale - Self Report (Fresco et al., 2001)
A self-report measure of fear and avoidance of social situations.

Secondary Outcome Measures

General Health Questionnaire-12 (Banks et al., 1980; Goldberg, 1978)
A self-report measure of overall psychological distress.
Patient-Reported Outcomes Measurement Information System (PROMIS) Satisfaction with Social Roles And Activities Short Form 8 v2.0 (Hahn et al., 2014)
A self-report measure of social functioning
Valuing Questionnaire - Progress subscale (Smout, Davies, Burns, & Christie, 2014)
A self-report measure of progress toward personal values.

Full Information

First Posted
September 13, 2017
Last Updated
November 9, 2019
Sponsor
Utah State University
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1. Study Identification

Unique Protocol Identification Number
NCT03297619
Brief Title
Self-help Books for Social Anxiety
Official Title
A Randomized Controlled Trial (RCT) Comparing Acceptance and Commitment Therapy (ACT) and Cognitive Behavioral Therapy (CBT) Self-help Books for Social Anxiety
Study Type
Interventional

2. Study Status

Record Verification Date
November 2019
Overall Recruitment Status
Completed
Study Start Date
September 16, 2017 (Actual)
Primary Completion Date
January 2, 2019 (Actual)
Study Completion Date
January 2, 2019 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Utah State University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief Summary
The goal of this study is to compare the efficacy and mechanisms of change of two self-help books for social anxiety in college students in a randomized controlled trial. One book is based on traditional cognitive behavioral therapy and one is based on acceptance and commitment therapy. This study will test the following hypotheses: Hypothesis 1: The CBT and ACT book conditions will both experience decreased social anxiety and distress. Life satisfaction and values progress will increase in both conditions. Hypothesis 2: The CBT condition will result in greater use of reappraisal, the ACT condition will not. Hypothesis 3: The ACT condition will result in greater use of defusion and decreased psychological inflexibility; the CBT condition will not. Hypothesis 4: Changes in experiential avoidance and defusion will predict changes in social anxiety and values progress in the ACT condition. Hypothesis 5: Changes in reappraisal will predict changes in social anxiety in the CBT condition. Change in values progress will be predicted by change in social anxiety in the CBT condition. Hypothesis 6: The association between social anxiety/negative affect and values progress will decrease or disappear in the ACT condition (i.e., decoupling), and remain the same in the CBT condition.
Detailed Description
The investigators aim to recruit 100 participants for this RCT (50 per treatment condition). This will provide adequate power (0.80) to detect differences between groups of medium effect size (d=0.50). Eligibility criteria will include being 18 years of age or older, being a current Utah State University (USU) student, not having participated in previous self-help studies conducted by the USU Contextual Behavioral Science (CBS) Lab, being interested in self-help for social anxiety, and scoring at least a 6 on the Mini-SPIN, a screener for social anxiety symptoms. Participants will be recruited via SONA, flyers, online postings, classroom announcements, and through a general online screener for various USU CBS Lab studies. Total study participation will occur over approximately 8 weeks. All study procedures will be completed online, on a computer/mobile phone. After completing informed consent, participants will complete a baseline survey. At the end of the baseline survey, participants will be randomly assigned to use a book based on CBT (The Shyness and Social Anxiety Workbook) or on ACT (The Mindfulness and Acceptance Workbook for Social Anxiety and Shyness). Note that participants will be asked not to access other self-help books during the study duration. Participants will be provided with an 8-week reading schedule and a link to the assigned book. Participants will be asked to complete a midtreatment survey 4 weeks after the beginning of treatment. The midtreatment survey will include questions about adherence. Participants will be asked to complete a posttreatment survey 8 weeks after the beginning of treatment. This survey will also ask about adherence (reading, use of strategies taught in the book, and exposures). Researcher contact will involve reminders to complete assessments, a basic email assistance in identifying and responding to any barriers to using the self-help book, and twice-weekly reminders of the suggested reading schedule. After completing the initial assessment participants will be sent a link to The Mindfulness and Acceptance Workbook for Social Anxiety and Shyness if they are assigned to the ACT condition, or a link to the Shyness and Social Anxiety Workbook if they are in the CBT condition. They will be able to access the book online at any time. Participants will be asked to read assigned chapters on an 8-week schedule. The primary treatment components in the Mindfulness and Acceptance Workbook for Social Anxiety and Shyness are psychoeducation, values and goals, mindfulness, acceptance, defusion, and committed action. The book uses writing exercises to identify patterns/values/goals/committed action, guided and unguided mindfulness meditations, and acceptance exercises. The primary treatment components in The Shyness and Social Anxiety Workbook are psychoeducation (introducing the cognitive behavioral model), self-assessment (e.g., anxiety hierarchy, identifying beliefs, identifying avoidance), cognitive restructuring, situational exposure, exposure to physical symptoms, and maintenance/consolidation. The book also includes a chapter on motivation and treatment options and a chapter on medication, but these were omitted in a previous trial of the book and will also be omitted in the present study. There is also a chapter on social skills, which will be omitted in order to keep dosage similar between the two books. The book briefly mentions acceptance in the context of exposure (e.g., fear will stick around longer after fighting it) but includes no major acceptance or mindfulness components.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Social Anxiety

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
Participants will be randomly assigned to one of two active self-help interventions for the duration of the study.
Masking
None (Open Label)
Allocation
Randomized
Enrollment
109 (Actual)

8. Arms, Groups, and Interventions

Arm Title
ACT self-help book condition
Arm Type
Experimental
Arm Description
Participants in this condition will be assigned to read The Mindfulness and Acceptance Workbook for Social Anxiety and Shyness by Fleming and Kocovski (2013), a self-help book based on acceptance and commitment therapy.
Arm Title
CBT self-help book condition
Arm Type
Active Comparator
Arm Description
Participants in this condition will be assigned to read The Shyness and Social Anxiety Workbook by Antony and Swinson (2008), a self-help book based on cognitive-behavioral therapy for social anxiety.
Intervention Type
Behavioral
Intervention Name(s)
Mindfulness and Acceptance Workbook for Social Anxiety and Shyness
Intervention Description
Participants assigned to this condition will be asked to read this self-help book over an 8-week period.
Intervention Type
Behavioral
Intervention Name(s)
The Shyness and Social Anxiety Workbook
Intervention Description
Participants assigned to this condition will be asked to read this self-help book over an 8-week period (with some chapters omitted).
Primary Outcome Measure Information:
Title
Liebowitz Social Anxiety Scale - Self Report (Fresco et al., 2001)
Description
A self-report measure of fear and avoidance of social situations.
Time Frame
Posttreatment (9 weeks after baseline)
Secondary Outcome Measure Information:
Title
General Health Questionnaire-12 (Banks et al., 1980; Goldberg, 1978)
Description
A self-report measure of overall psychological distress.
Time Frame
Baseline, midtreatment (5 weeks after baseline), and posttreatment (9 weeks after baseline)
Title
Patient-Reported Outcomes Measurement Information System (PROMIS) Satisfaction with Social Roles And Activities Short Form 8 v2.0 (Hahn et al., 2014)
Description
A self-report measure of social functioning
Time Frame
Baseline, midtreatment (5 weeks after baseline), and posttreatment (9 weeks after baseline)
Title
Valuing Questionnaire - Progress subscale (Smout, Davies, Burns, & Christie, 2014)
Description
A self-report measure of progress toward personal values.
Time Frame
Baseline, midtreatment (5 weeks after baseline), and posttreatment (9 weeks after baseline)
Other Pre-specified Outcome Measures:
Title
Believability of Anxious Feelings and Thoughts Questionnaire (Herzberg et al., 2012)
Description
A self-report measure of cognitive fusion as it relates to anxiety.
Time Frame
Baseline, midtreatment (5 weeks after baseline), and posttreatment (9 weeks after baseline)
Title
Cognitive Fusion Questionnaire (Gillanders et al., 2014)
Description
A self-report measure of overall cognitive fusion.
Time Frame
Baseline, midtreatment (5 weeks after baseline), and posttreatment (9 weeks after baseline)
Title
Appraisal of Social Concerns Scale (Telch et al., 2004)
Description
A self-report measure of concern regarding negative social outcomes.
Time Frame
Baseline, midtreatment (5 weeks after baseline), and posttreatment (9 weeks after baseline)
Title
Reappraisal and mindfulness items (Goldin, Morrison, Jazaieri, Heimberg, & Gross, 2017)
Description
These items will be used to measure use of cognitive reappraisal and mindful acceptance.
Time Frame
Baseline, midtreatment (5 weeks after baseline), and posttreatment (9 weeks after baseline)

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Age 18 or older Enrolled at Utah State University Have not participated in other self-help studies run by the USU CBS Lab Interested in using self-help book for social anxiety Scoring at least a 6 on the Mini Social Phobia Inventory (Mini-SPIN), a validated social anxiety screening measure Exclusion Criteria: Exclusion criteria mirror inclusion criteria: below the age of 18, not a student at Utah State University, have participated in previous self-help studies run by the CBS Lab, not interested in using a self-help book for social anxiety, or scoring a 5 or lower on the Mini-SPIN.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Michael Levin, PhD
Organizational Affiliation
Utah State University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Utah State University
City
Logan
State/Province
Utah
ZIP/Postal Code
84322
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
Undecided
Citations:
PubMed Identifier
11668666
Citation
Connor KM, Kobak KA, Churchill LE, Katzelnick D, Davidson JR. Mini-SPIN: A brief screening assessment for generalized social anxiety disorder. Depress Anxiety. 2001;14(2):137-40. doi: 10.1002/da.1055.
Results Reference
background
Citation
Antony, M. M., & Swinson, R. P. (2008). The shyness and social anxiety workbook. Oakland, CA: New Harbinger Publications, Inc.
Results Reference
background
Citation
Fleming, J. E., & Kocovski, N. L. (2013). The mindfulness and acceptance workbook for social anxiety and shyness. Oakland, CA: New Harbinger Publications, Inc.
Results Reference
background
PubMed Identifier
18514614
Citation
Abramowitz JS, Moore EL, Braddock AE, Harrington DL. Self-help cognitive-behavioral therapy with minimal therapist contact for social phobia: a controlled trial. J Behav Ther Exp Psychiatry. 2009 Mar;40(1):98-105. doi: 10.1016/j.jbtep.2008.04.004. Epub 2008 Apr 26.
Results Reference
background
PubMed Identifier
11513370
Citation
Fresco DM, Coles ME, Heimberg RG, Liebowitz MR, Hami S, Stein MB, Goetz D. The Liebowitz Social Anxiety Scale: a comparison of the psychometric properties of self-report and clinician-administered formats. Psychol Med. 2001 Aug;31(6):1025-35. doi: 10.1017/s0033291701004056.
Results Reference
background
Citation
Banks, M. H., Clegg, C. W., Jackson, P. R., Kemp, N. J., Stafford, E. M., & Wall, T. D. (1980). The use of the General Health Questionnaire as an indicator of mental health in occupational studies. Journal of Occupational Psychology, 53, 187-194.
Results Reference
background
Citation
Goldberg, D. (1978). Manual of the GHQ. Windsor: NFER.
Results Reference
background
PubMed Identifier
24447188
Citation
Hahn EA, DeWalt DA, Bode RK, Garcia SF, DeVellis RF, Correia H, Cella D; PROMIS Cooperative Group. New English and Spanish social health measures will facilitate evaluating health determinants. Health Psychol. 2014 May;33(5):490-9. doi: 10.1037/hea0000055. Epub 2014 Jan 20.
Results Reference
background
Citation
Smout, M., Davies, M., Burns, N., & Christie, A. (2014). Development of the Valuing Questionnaire (VQ). Journal of Contextual Behavioral Science, 3, 164-172. http://doi.org/10.1016/j.jcbs.2014.06.001
Results Reference
background
PubMed Identifier
22486595
Citation
Herzberg KN, Sheppard SC, Forsyth JP, Crede M, Earleywine M, Eifert GH. The Believability of Anxious Feelings and Thoughts Questionnaire (BAFT): a psychometric evaluation of cognitive fusion in a nonclinical and highly anxious community sample. Psychol Assess. 2012 Dec;24(4):877-91. doi: 10.1037/a0027782. Epub 2012 Apr 9.
Results Reference
background
PubMed Identifier
24411117
Citation
Gillanders DT, Bolderston H, Bond FW, Dempster M, Flaxman PE, Campbell L, Kerr S, Tansey L, Noel P, Ferenbach C, Masley S, Roach L, Lloyd J, May L, Clarke S, Remington B. The development and initial validation of the cognitive fusion questionnaire. Behav Ther. 2014 Jan;45(1):83-101. doi: 10.1016/j.beth.2013.09.001. Epub 2013 Sep 18.
Results Reference
background
PubMed Identifier
17071216
Citation
Schultz LT, Heimberg RG, Rodebaugh TL, Schneier FR, Liebowitz MR, Telch MJ. The appraisal of social concerns scale: psychometric validation with a clinical sample of patients with social anxiety disorder. Behav Ther. 2006 Dec;37(4):392-405. doi: 10.1016/j.beth.2006.06.001. Epub 2006 Aug 4.
Results Reference
background
PubMed Identifier
15274170
Citation
Telch MJ, Lucas RA, Smits JA, Powers MB, Heimberg R, Hart T. Appraisal of social concerns: a cognitive assessment instrument for social phobia. Depress Anxiety. 2004;19(4):217-24. doi: 10.1002/da.20004.
Results Reference
background
PubMed Identifier
28654771
Citation
Goldin PR, Morrison AS, Jazaieri H, Heimberg RG, Gross JJ. Trajectories of social anxiety, cognitive reappraisal, and mindfulness during an RCT of CBGT versus MBSR for social anxiety disorder. Behav Res Ther. 2017 Oct;97:1-13. doi: 10.1016/j.brat.2017.06.001. Epub 2017 Jun 3.
Results Reference
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Self-help Books for Social Anxiety

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