Clinical trial NCT03673046: Waitlist-Control Trial of Smartphone Cognitive Behavioral Therapy (CBT) for Body Dysmorphic Disorder (BDD)
Official title: Smartphone Cognitive Behavioral Therapy for Body Dysmorphic Disorder: A Randomized, Waitlist-control Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Body Dysmorphic Disorder
Lead sponsor: Massachusetts General Hospital
Sponsor class: OTHER
Collaborators: name: Koa Health B.V.
First posted: 2018-09-17
Enrollment: 80
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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).

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

Primary outcomes:
measure: Difference in BDD Severity (BDD-YBOCS) at the End of Treatment/Waitlist Period.
timeFrame: Week 0, Week 6, and Week 12
Secondary outcomes:
measure: Difference in Depression at the End of Treatment/Waitlist Period
timeFrame: Week 0, Week 6, and Week 12
measure: Difference in Delusionality at the End of Treatment/Waitlist Period
timeFrame: Week 0, Week 6, and Week 12
measure: Difference in Functional Impairment at the End of Treatment/Waitlist Period
timeFrame: Week 0, Week 6, and Week 12
measure: Difference in Quality of Life at the End of Treatment/Waitlist Period
timeFrame: Week 0, Week 6, and Week 12
Other outcomes:
Locations:
city: Boston
country: United States
facility: Massachusetts General Hospital
state: Massachusetts
Study officials:
affiliation: Massachusetts General Hospital
name: Sabine Wilhelm, PhD
role: PRINCIPAL_INVESTIGATOR
References: