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

Smartphone Cognitive Behavioral Therapy for Body Dysmorphic Disorder: A Randomized, Waitlist-control Trial

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 BDD-YBOCS scores than those in the waitlist condition at treatment endpoint (week 12).

Study Overview

• Status: Active, not recruiting
• Conditions: Body Dysmorphic Disorders
• Intervention / Treatment: Device: Smartphone-delivered CBT for BDD

Detailed Description

The primary aim of this study is to test the efficacy of a Smartphone-based CBT treatment for adults with 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 Type: Interventional
• Enrollment (Actual): 80
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Massachusetts
    • Boston, Massachusetts, United States, 02114
      • Massachusetts General Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• At least 18 years of age
• Current diagnosis of primary DSM-5 BDD, based on MINI
• 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 CBT for 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 C-SSRS.
• Current severe comorbid major depression, as indicated by clinical judgment and/or a 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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Crossover Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Smartphone-delivered CBT for BDD; 12-week Smartphone-delivered CBT for BDD.	Device: Smartphone-delivered CBT for BDD; 12-week Smartphone-delivered CBT for BDD. In-person cognitive behavioral therapy (CBT) is an empirically supported treatment for BDD. The app-delivered CBT in this project includes modules such as cognitive skills (e.g., cognitive restructuring, core belief work), behavioral skills (e.g., exposure with ritual prevention), and perceptual retraining/mindfulness skills.
Other: 12 Week Waitlist Control; 12 week waitlist control. (Note: participants will be crossed over to 12-week Smartphone-delivered CBT for BDD following the 12-week waitlist control).	Device: Smartphone-delivered CBT for BDD; 12-week Smartphone-delivered CBT for BDD. In-person cognitive behavioral therapy (CBT) is an empirically supported treatment for BDD. The app-delivered CBT in this project includes modules such as cognitive skills (e.g., cognitive restructuring, core belief work), behavioral skills (e.g., exposure with ritual prevention), and perceptual retraining/mindfulness skills.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Difference in BDD severity (BDD-YBOCS) at the end of treatment/waitlist period.	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 will be used to assess change in BDD symptoms from baseline to endpoint.	Endpoint (week 12)

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Difference in depression at the end of treatment/waitlist period	Participants who receive app-CBT will have greater improvement on depression (QIDS-SR). The QIDS-SR is a self-report measure of depressive symptoms consisting of 16 scale items with responses ranging from 0 to 3, including one suicide item (item #12). Higher scores correspond with greater depression severity, and the measure is a well-validated, sensitive measure of symptom severity in depression.	Endpoint (week 12)
Difference in functional impairment at the end of treatment/waitlist period	Participants who receive app-CBT will have greater improvement on functional impairment (SDS). The SDS uses a Likert scale from 0 (not at all) to 10 (extremely) to assess impairment in occupational, social, and family domains. Higher scores indicate greater impairment.	Endpoint (week 12)
Difference in quality of life at the end of treatment/waitlist period	Participants who receive app-CBT will have greater improvement on quality of life, assessed using The Quality of Life, Enjoyment, and Satisfaction Questionnaire - Short Form (Q-LES-Q). The Q-LES-Q-SF is a self-report measure of subjective quality of life, containing Likert items ranging from 1 (Very Poor) to 5 (Very Good). Total scores are presented as a percentage of the maximum value (i.e., ranging from 0 to 100, with higher scores indicating greater quality of life).	Endpoint (week 12)
Difference in delusionality at the end of treatment/waitlist period	Participants who receive app-CBT will have greater improvement on delusionality, assessed using the Brown Assessment of Beliefs Scale (BABS).The BABS is a semi-structured, clinician-administered interview that assesses delusional thinking related to one's appearance concerns. It contains 7 items ranging from 0-4, which are summed to generate a total score (range= 0-24). Higher scores indicate greater delusionality.	Endpoint (week 12)

Collaborators and Investigators

• Sponsor: Koa Health B.V.
• Collaborators: Massachusetts General Hospital

Study record dates

Study Major Dates

• Study Start (Actual): August 12, 2019
• Primary Completion (Anticipated): January 15, 2022
• Study Completion (Anticipated): January 15, 2022

Study Registration Dates

• First Submitted: July 24, 2019
• First Submitted That Met QC Criteria: July 24, 2019
• First Posted (Actual): July 26, 2019

Study Record Updates

• Last Update Posted (Actual): April 28, 2021
• Last Update Submitted That Met QC Criteria: April 26, 2021
• Last Verified: April 1, 2021

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Mental Disorders; Somatoform Disorders; Body Dysmorphic Disorders
• Other Study ID Numbers: 2017P000293_B

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes
• product manufactured in and exported from the U.S.: No