Waitlist-Control Trial of Smartphone Cognitive Behavioral Therapy (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 body dysmorphic disorder symptom severity than those in the waitlist condition at treatment endpoint (week 12).

Study Overview

• Status: Completed
• Conditions: Body Dysmorphic Disorder
• Intervention / Treatment: Device: Smartphone-delivered cognitive behavioral therapy (CBT) for body dysmorphic disorder (BDD)

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 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: 16 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 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

Study Plan

How is the study designed?

Design Details

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

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
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 cognitive behavioral therapy (CBT) for body dysmorphic disorder (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.
Experimental: Smartphone-delivered cognitive behavioral therapy (CBT) for body dysmorphic disorder (BDD); 12-week Smartphone-delivered CBT for BDD.	Device: Smartphone-delivered cognitive behavioral therapy (CBT) for body dysmorphic disorder (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	Week 0, Week 6, and Week 12

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Difference in Depression at the End of Treatment/Waitlist Period	The self-report Quick Inventory of Depressive Symptomatology (QIDS-SR) is a measure of depressive symptoms consisting of 16 scale items with responses ranging from 0 to 3, including one suicide item (item #12). Total scores have a range from 0 to 27 with higher scores indicating greater depression severity. The measure is a well-validated, sensitive measure of symptom severity in depression.	Week 0, Week 6, and Week 12
Difference in Delusionality at the End of Treatment/Waitlist Period	Delusionality was 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; the first six items are summed to generate a total score (range: 0-24). Higher scores indicate greater delusionality.	Week 0, Week 6, and Week 12
Difference in Functional Impairment at the End of Treatment/Waitlist Period	Functional impairment was measured using the Sheehan Disability Scale (SDS). The SDS is a self-rated, 3-item questionnaire that uses a Likert scale from 0 (not at all) to 10 (extremely) to assess impairment in occupational, social, and family domains. The 3 items are summed for a total score (range: 0-30), where higher scores indicate greater functional impairment.	Week 0, Week 6, and Week 12
Difference in Quality of Life at the End of Treatment/Waitlist Period	Quality of life was assessed using The Quality of Life, Enjoyment, and Satisfaction Questionnaire - Short Form (Q-LES-Q-SF). The Q-LES-Q-SF is a 16-item 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.	Week 0, Week 6, and Week 12

Collaborators and Investigators

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

Study record dates

Study Major Dates

• Study Start (Actual): September 17, 2019
• Primary Completion (Actual): June 17, 2021
• Study Completion (Actual): October 3, 2022

Study Registration Dates

• First Submitted: September 11, 2018
• First Submitted That Met QC Criteria: September 13, 2018
• First Posted (Actual): September 17, 2018

Study Record Updates

• Last Update Posted (Actual): October 7, 2022
• Last Update Submitted That Met QC Criteria: October 3, 2022
• Last Verified: October 1, 2022

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