N/A
N=80
Waitlist-Control Trial of Smartphone Cognitive Behavioral Therapy (CBT) for Body Dysmorphic Disorder (BDD)
Body Dysmorphic Disorder
Bottom Line
View on ClinicalTrials.gov: NCT03673046 ↗Enrolled (actual)
80
Serious AEs
0.0%
Results posted
Sep 2022
Primary outcome: Primary: Difference in BDD Severity (BDD-YBOCS) at the End of Treatment/Waitlist Period. — 29.85; 30.85; 23.77; 27.13 score on a scale — p=<.0001
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- Smartphone-delivered cognitive behavioral therapy (CBT) for body dysmorphic disorder (BDD) (Device)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Massachusetts General Hospital
- Primary completion
- Jun 2021
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Difference in BDD Severity (BDD-YBOCS) at the End of Treatment/Waitlist Period. |
29.85; 30.85; 23.77; 27.13; 16.81; 26.70 | <.0001 sig |
| SECONDARY Difference in Depression at the End of Treatment/Waitlist Period |
11.13; 11.43; 10.15; 10.08; 7.11; 10.31 | 0.0023 sig |
| SECONDARY Difference in Delusionality at the End of Treatment/Waitlist Period |
15.10; 14.45; 12.26; 13.50; 8.30; 13.22 | <.0001 sig |
| SECONDARY Difference in Functional Impairment at the End of Treatment/Waitlist Period |
15.95; 17.08; 11.09; 13.22; 7.64; 13.49 | .0008 sig |
| SECONDARY Difference in Quality of Life at the End of Treatment/Waitlist Period |
52.72; 48.35; 53.99; 52.12; 66.45; 55.20 | .0011 sig |
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).
Eligibility Criteria
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
Data sourced from ClinicalTrials.gov (NCT03673046). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.