Self-help Books for Social Anxiety

Social Anxiety Clinical Trial

Official title:

A Randomized Controlled Trial (RCT) Comparing Acceptance and Commitment Therapy (ACT) and Cognitive Behavioral Therapy (CBT) Self-help Books for Social Anxiety

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03297619
• Other study ID #: 8694
• Status: Completed
• Phase: N/A
• Start date: September 16, 2017
• Est. completion date: January 2, 2019

Study information

• Verified date: November 2019
• Source: Utah State University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 109
• Est. completion date: January 2, 2019
• Est. primary completion date: January 2, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Anxiety Disorders
• Social Anxiety

Intervention

Behavioral:
• Mindfulness and Acceptance Workbook for Social Anxiety and Shyness
Participants assigned to this condition will be asked to read this self-help book over an 8-week period.
• The Shyness and Social Anxiety Workbook
Participants assigned to this condition will be asked to read this self-help book over an 8-week period (with some chapters omitted).

Locations

Country	Name	City	State
United States	Utah State University	Logan	Utah

Sponsors (1)

Lead Sponsor	Collaborator
Utah State University

Country where clinical trial is conducted

United States, 

References & Publications (14)

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. — View Citation

Antony, M. M., & Swinson, R. P. (2008). The shyness and social anxiety workbook. Oakland, CA: New Harbinger Publications, Inc.

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.

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. — View Citation

Fleming, J. E., & Kocovski, N. L. (2013). The mindfulness and acceptance workbook for social anxiety and shyness. Oakland, CA: New Harbinger Publications, Inc.

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. — View 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. — View Citation

Goldberg, D. (1978). Manual of the GHQ. Windsor: NFER.

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. — View 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. — View Citation

Herzberg KN, Sheppard SC, Forsyth JP, Credé 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. — View 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. Epub 2006 Aug 4. — View 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

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. — View Citation

* Note: There are 14 references in all — Click here to view all references

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Believability of Anxious Feelings and Thoughts Questionnaire (Herzberg et al., 2012)	A self-report measure of cognitive fusion as it relates to anxiety.	Baseline, midtreatment (5 weeks after baseline), and posttreatment (9 weeks after baseline)
Other	Cognitive Fusion Questionnaire (Gillanders et al., 2014)	A self-report measure of overall cognitive fusion.	Baseline, midtreatment (5 weeks after baseline), and posttreatment (9 weeks after baseline)
Other	Appraisal of Social Concerns Scale (Telch et al., 2004)	A self-report measure of concern regarding negative social outcomes.	Baseline, midtreatment (5 weeks after baseline), and posttreatment (9 weeks after baseline)
Other	Reappraisal and mindfulness items (Goldin, Morrison, Jazaieri, Heimberg, & Gross, 2017)	These items will be used to measure use of cognitive reappraisal and mindful acceptance.	Baseline, midtreatment (5 weeks after baseline), and posttreatment (9 weeks after baseline)
Primary	Liebowitz Social Anxiety Scale - Self Report (Fresco et al., 2001)	A self-report measure of fear and avoidance of social situations.	Posttreatment (9 weeks after baseline)
Secondary	General Health Questionnaire-12 (Banks et al., 1980; Goldberg, 1978)	A self-report measure of overall psychological distress.	Baseline, midtreatment (5 weeks after baseline), and posttreatment (9 weeks after baseline)
Secondary	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	Baseline, midtreatment (5 weeks after baseline), and posttreatment (9 weeks after baseline)
Secondary	Valuing Questionnaire - Progress subscale (Smout, Davies, Burns, & Christie, 2014)	A self-report measure of progress toward personal values.	Baseline, midtreatment (5 weeks after baseline), and posttreatment (9 weeks after baseline)