Smartphone Cognitive Behavioral Therapy for Social Anxiety Disorder: A Randomized, Waitlist-control Trial
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Social Anxiety Disorder
- Sponsor
- Massachusetts General Hospital
- Locations
- 1
- Primary Endpoint
- Difference in SAD severity (LSAS) at the end of treatment/waitlist period.
- Status
- Withdrawn
- Last Updated
- 11 months ago
Overview
Brief Summary
The investigators are testing the efficacy of Smartphone-delivered cognitive behavioral therapy (CBT) treatment for social anxiety disorder (SAD). The investigators hypothesize that participants receiving app-CBT will have greater reduction in LSAS scores than those in the waitlist condition at treatment endpoint (week 12).
Detailed Description
The primary aims of this study are to test the efficacy of a Smartphone-based CBT treatment for adults with SAD recruited nationally. Eligible subjects (N=80) will be randomly assigned to 12 weeks of Smartphone-delivered CBT for SAD either immediately, or after a 12-week long waiting period (50-50 chance). The investigators hypothesize that Smartphone-delivered CBT for SAD will be feasible and acceptable to individuals with SAD, and that it will lead to greater reductions in SAD symptom severity compared to the passage of time (waitlist control).
Investigators
Sabine Wilhelm, PhD
Chief of Phycology
Massachusetts General Hospital
Eligibility Criteria
Inclusion Criteria
- •At least 18 years of age
- •Current diagnosis of primary DSM-5 SAD, based on MINI
- •Currently living in the United States
Exclusion Criteria
- •Psychotropic medication changes within 2 months prior to enrollment i. Participants taking psychotropic medication must have been on a stable dose for at least 2 months prior to enrollment and not change medication during study period
- •Past participation in ≥ 4 sessions of CBT for SAD
- •Current severe substance use disorder
- •Lifetime bipolar disorder or psychosis
- •Current severe comorbid major depression, as indicated by clinical judgment and/or a QIDS-SR total score ≥ 21 \*\*\*EDIT\*\*\*
- •Acute, active suicidal ideation as indicated by clinical judgment and/or a score ≥ 2 on the suicidal ideation subscale of the C-SSRS
- •Concurrent psychological treatment
- •Does not own a supported mobile Smartphone with a data plan
- •Lack of technology literacy that would interfere with ability to engage with smartphone treatment
Outcomes
Primary Outcomes
Difference in SAD severity (LSAS) at the end of treatment/waitlist period.
Time Frame: Endpoint (week 12)
The Liebowitz Social Anxiety Scale (LSAS) is a clinician-administered measure of social anxiety symptom severity. It contains 24 social situations likely to elicit social anxiety, and items are scored on a Likert scale ranging from 0 to 3. Higher scores indicate more severe SAD symptoms. The LSAS will be used to assess change in social anxiety symptoms from baseline to endpoint.
Secondary Outcomes
- Difference in functional impairment as measured by change in The Work and Social Adjustment Scale (WSAS) total scores from baseline to week 12.(Endpoint (week 12))
- Difference in quality of life as assessed by change in The Quality of Life, Enjoyment, and Satisfaction Questionnaire-Short Form (QLESQ-SR) total scores from baseline to week 12.(Endpoint (week 12))
- Difference in depression severity as assessed by change in The Center for Epidemiologic Studies Depression Scale - Revised (CESD-R) total scores from baseline to week 12.(Endpoint (week 12))