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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.


Clinical Trial 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. ;


Study Design


Related Conditions & MeSH terms


NCT number NCT03297619
Study type Interventional
Source Utah State University
Contact
Status Completed
Phase N/A
Start date September 16, 2017
Completion date January 2, 2019

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