Smartphone-Administered App Treatment for Adults With Body Dysmorphic Disorder

NCT ID: NCT03221738

Last Updated: 2019-06-26

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 10 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2017-07-24
• Study Completion Date: 2019-01-18

Brief Summary

The investigators are developing and testing a Smartphone-based cognitive behavioral therapy (CBT) "app" for body dysmorphic disorder (BDD). The investigators hypothesize that app-based CBT for BDD will be feasible and acceptable to individuals with BDD, and will improve body image concerns and related outcomes.

Detailed Description

The primary aims of this study are to develop and test the feasibility, acceptability, and preliminary efficacy of a Smartphone-based CBT treatment for adults with BDD. This project aims to solve two healthcare problems: poor access to empirically-supportive treatment for BDD, and challenges of generalizing CBT skills outside therapy sessions. Inadequate treatment access is due to limited professionals offering this specialized treatment, economic barriers, and shame preventing sufferers from seeking in-person care. Mobile app-based CBT would solve this access gap by addressing each of these barriers. Among those who obtain CBT, practicing skills outside of therapy is critical for treatment effectiveness, as BDD symptoms occur around-the-clock and can be most impairing at home. However, BDD patients struggle to use skills without therapists' in-person support. App-based CBT that provides on-hand skills coaching addresses this treatment generalization challenge.

This study involves developing the app-based CBT for BDD treatment, and then investigating the initial feasibility, acceptability, and preliminary efficacy of the app-based treatment in an open pilot trial (N = 10), consisting of 12-weeks of active treatment plus a 6-month follow up period.

Conditions

Body Dysmorphic Disorders

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

App-Based Cognitive Behavioral Therapy

12-week Smartphone-delivered CBT for BDD.

Group Type: EXPERIMENTAL

App-Based Cognitive Behavioral Therapy

Intervention Type: BEHAVIORAL

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.

Interventions

App-Based Cognitive Behavioral Therapy

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.

Intervention Type: BEHAVIORAL

Eligibility Criteria

Inclusion Criteria

• At least 18 years of age
• Outpatients
• Meets current diagnosis of primary DSM-5 BDD
• Has score on BDD-YBOCS of ≥ 20
• Currently living in the United States

Exclusion Criteria

• Psychotropic medication changes within 2 months prior to enrollment
• Participants taking psychotropic medication have to have been on a stable dose for at least 2 months prior to enrollment and not change medication during study period
• Participated in CBT for BDD ever during lifetime
• Current substance dependence
• Lifetime bipolar disorder or psychosis
• Acute, active suicidal ideation
• Current severe comorbid major depression, defined by a PHQ-9 total score ≥ 20
• Personality disorder that could jeopardize treatment participation (e.g., borderline personality disorder with self-harm)
• Concurrent psychological treatment
• Do not own a supported mobile Smart phone with a data plan (currently iPhone 5S or more recent, running iOS 9 or newer)
• Intellectual disability or other cognitive impairment that would interfere with ability to engage in CBT

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Telefónica S.A.

INDUSTRY

Sponsor Role: collaborator

Massachusetts General Hospital

OTHER

Sponsor Role: lead

Responsible Party

Sabine Wilhelm, PhD

Sabine Wilhelm, Ph.D., Chief of Psychology

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Sabine Wilhelm, Ph.D.

Role: PRINCIPAL_INVESTIGATOR

Massachusetts General Hospital

Locations

Massachusetts General Hospital

Boston, Massachusetts, United States

Countries

United States

References

Wilhelm S, Weingarden H, Greenberg JL, McCoy TH, Ladis I, Summers BJ, Matic A, Harrison O. Development and Pilot Testing of a Cognitive-Behavioral Therapy Digital Service for Body Dysmorphic Disorder. Behav Ther. 2020 Jan;51(1):15-26. doi: 10.1016/j.beth.2019.03.007. Epub 2019 Aug 7.

Reference Type: DERIVED

PMID: 32005333 (View on PubMed)

Provided Documents

Document Type: Study Protocol and Statistical Analysis Plan

View Document

Other Identifiers

2017P000293_A

Identifier Type: -

Identifier Source: org_study_id