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

NCT03673046 | Completed Results DMC FDA Device

• 1 other identifier: 2017P000293_B
• Study Type: interventional
• Target: 80
• Locations: 1 country
• Sites: 1

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).

Conditions

Body Dysmorphic Disorder

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (4)

• Difference in Depression at the End of Treatment/Waitlist Period

  Week 0, Week 6, and Week 12

• Difference in Delusionality at the End of Treatment/Waitlist Period

  Week 0, Week 6, and Week 12

• Difference in Functional Impairment at the End of Treatment/Waitlist Period

  Week 0, Week 6, and Week 12

• Difference in Quality of Life at the End of Treatment/Waitlist Period

  Week 0, Week 6, and Week 12

Study Arms (2)

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

EXPERIMENTAL

12-week Smartphone-delivered CBT for BDD.

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

12 Week Waitlist Control

OTHER

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)

Interventions

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

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.

12 Week Waitlist Control; Smartphone-delivered cognitive behavioral therapy (CBT) for body dysmorphic disorder (BDD)

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Massachusetts General Hospital: lead
• Koa Health B.V.: collaborator

Study Sites (1)

Massachusetts General Hospital

Boston, Massachusetts, 02114, United States

Location

Related Publications (1)

• Weingarden H, Garriga Calleja R, Greenberg JL, Snorrason I, Matic A, Quist R, Harrison O, Hoeppner SS, Wilhelm S. Characterizing observed and effective behavioral engagement with smartphone cognitive behavioral therapy for body dysmorphic disorder: A methods roadmap and use case. Internet Interv. 2023 Mar 16;32:100615. doi: 10.1016/j.invent.2023.100615. eCollection 2023 Apr.

  PMID: 36969390 DERIVED

MeSH Terms

Conditions

Body Dysmorphic Disorders

Condition Hierarchy (Ancestors)

Somatoform Disorders; Mental Disorders

Results Point of Contact

• Title: Director, Center for OCD and Related Disorders
• Organization: Massachusetts General Hospital, Department of Psychiatry

swilhelm@mgh.harvard.edu

617-724-6146

Study Officials

• Sabine Wilhelm, PhD

  Massachusetts General Hospital

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Chief of Psychology

Study Record Dates

• First Submitted: September 11, 2018
• First Posted: September 17, 2018
• Study Start: September 17, 2019
• Primary Completion: June 17, 2021
• Study Completion: October 3, 2022
• Last Updated: October 7, 2022
• Results First Posted: September 14, 2022

Record last verified: 2022-10

Locations

US (1)