Smartphone Cognitive Behavioral Therapy for Body Dysmorphic Disorder: A Randomized, Waitlist-control Trial
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Enrollment
- 80
- Locations
- 2
- Primary Endpoint
- Difference in BDD Severity (BDD-YBOCS) at the End of Treatment/Waitlist Period.
Study Overview
Brief Summary
The investigators are testing the efficacy of Smartphone-delivered cognitive behavioral therapy (CBT) treatment for body dysmorphic disorder (BDD). The investigators hypothesize that participants receiving app-CBT will have greater improvement in body dysmorphic disorder symptom severity than those in the waitlist condition at treatment endpoint (week 12).
Detailed Description
The primary aim of this study is to test the efficacy of a Smartphone-based cognitive behavioral therapy (CBT) treatment for adults with body dysmorphic disorder (BDD) recruited nationally. In a prior study (Clinical Trials Identifier # NCT03221738), the investigators developed and pilot-tested the feasibility, acceptability, and preliminary efficacy of a CBT for BDD app in an open pilot trial. The investigators are now further testing these outcomes in a randomized controlled trial. Eligible subjects (N= 64) will be randomly assigned to 12-weeks of Smartphone-delivered CBT for BDD either immediately, or after a 12-week long waiting period (50/50 chance).
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- Single (Outcomes Assessor)
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •at least 18 years of age
- •current diagnosis of primary body dysmorphic disorder (BDD), based on a clinical structured diagnostic interview
- •currently living in the United States
Exclusion Criteria
- •Psychotropic medication changes within 2 months prior to enrollment (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 cognitive behavioral therapy (CBT) for body dysmorphic disorder (BDD)
- •Current severe substance use disorder
- •Lifetime bipolar disorder or psychosis
- •Acute, active suicidal ideation as indicated by clinical judgment and/or a score >2 on the suicidal ideation subscale of the Columbia-Suicide Severity Rating Scale (C-SSRS).
- •Current severe comorbid major depression, as indicated by clinical judgment and/or a Quick Inventory of Depressive Symptomatology- Self Report (QIDS-SR) total score ≥ 21
- •Concurrent psychological treatment
- •Does not own a supported Smartphone with a data plan
- •Lack of technology literacy that would interfere with ability to engage with smartphone treatment
Outcomes
Primary Outcomes
Difference in BDD Severity (BDD-YBOCS) at the End of Treatment/Waitlist Period.
Time Frame: Week 0, Week 6, and Week 12
The BDD Yale-Brown Obsessive Compulsive Scale (BDD-YBOCS) is the gold-standard, semi-structured clinician-administered assessment of BDD severity. It contains 12 items ranging from 0 to 4, which are summed to generate a total score (range = 0 to 48). Higher scores indicate more severe BDD symptoms. The BDD-YBOCS
Secondary Outcomes
- Difference in Delusionality at the End of Treatment/Waitlist Period(Week 0, Week 6, and Week 12)
- Difference in Depression at the End of Treatment/Waitlist Period(Week 0, Week 6, and Week 12)
- Difference in Functional Impairment at the End of Treatment/Waitlist Period(Week 0, Week 6, and Week 12)
- Difference in Quality of Life at the End of Treatment/Waitlist Period(Week 0, Week 6, and Week 12)
Investigators
Sabine Wilhelm, PhD
Chief of Psychology
Massachusetts General Hospital