Clinical trial NCT03297619: 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
Overall status: COMPLETED
Phase: NA
Conditions: Social Anxiety
Lead sponsor: Utah State University
Sponsor class: OTHER
First posted: 2017-09-29
Enrollment: 109
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Participants will be randomly assigned to one of two active self-help interventions for the duration of the study.
Primary purpose: TREATMENT

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.

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.

Primary outcomes:
measure: Liebowitz Social Anxiety Scale - Self Report (Fresco et al., 2001)
timeFrame: Posttreatment (9 weeks after baseline)
Secondary outcomes:
measure: General Health Questionnaire-12 (Banks et al., 1980; Goldberg, 1978)
timeFrame: Baseline, midtreatment (5 weeks after baseline), and posttreatment (9 weeks after baseline)
measure: Patient-Reported Outcomes Measurement Information System (PROMIS) Satisfaction with Social Roles And Activities Short Form 8 v2.0 (Hahn et al., 2014)
timeFrame: Baseline, midtreatment (5 weeks after baseline), and posttreatment (9 weeks after baseline)
measure: Valuing Questionnaire - Progress subscale (Smout, Davies, Burns, & Christie, 2014)
timeFrame: Baseline, midtreatment (5 weeks after baseline), and posttreatment (9 weeks after baseline)
Other outcomes:
measure: Believability of Anxious Feelings and Thoughts Questionnaire (Herzberg et al., 2012)
timeFrame: Baseline, midtreatment (5 weeks after baseline), and posttreatment (9 weeks after baseline)
measure: Cognitive Fusion Questionnaire (Gillanders et al., 2014)
timeFrame: Baseline, midtreatment (5 weeks after baseline), and posttreatment (9 weeks after baseline)
measure: Appraisal of Social Concerns Scale (Telch et al., 2004)
timeFrame: Baseline, midtreatment (5 weeks after baseline), and posttreatment (9 weeks after baseline)
measure: Reappraisal and mindfulness items (Goldin, Morrison, Jazaieri, Heimberg, & Gross, 2017)
timeFrame: Baseline, midtreatment (5 weeks after baseline), and posttreatment (9 weeks after baseline)
Locations:
city: Logan
country: United States
facility: Utah State University
state: Utah
Study officials:
affiliation: Utah State University
name: Michael Levin, PhD
role: PRINCIPAL_INVESTIGATOR
References:
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.
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