Waitlist-Control Trial of Smartphone Cognitive Behavioral Therapy (CBT) for Body Dysmorphic Disorder (BDD)

Mass General Brigham

Status: Completed

Conditions: Body Dysmorphic Disorder

Treatments: Device: Smartphone-delivered cognitive behavioral therapy (CBT) for body dysmorphic disorder (BDD)

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT03673046

2017P000293_B

Details and patient eligibility

About

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).

Full 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).

Enrollment: 80 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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80 participants in 2 patient groups

Smartphone-delivered cognitive behavioral therapy (CBT) for body dysmorphic disorder (BDD)

Experimental group

Description:

12-week Smartphone-delivered CBT for BDD.

Treatment:

Device: Smartphone-delivered cognitive behavioral therapy (CBT) for body dysmorphic disorder (BDD)

12 Week Waitlist Control

Other group

Description:

12 week waitlist control. (Note: participants will be crossed over to 12-week Smartphone-delivered CBT for BDD following the 12-week waitlist control).

Treatment:

Device: Smartphone-delivered cognitive behavioral therapy (CBT) for body dysmorphic disorder (BDD)