Development of a Cognitive Behavioral Mobile App for Body Dysmorphic Disorder, and Tests of Feasibility, Acceptability, and Preliminary Efficacy
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Body Dysmorphic Disorders
- Sponsor
- Massachusetts General Hospital
- Enrollment
- 10
- Locations
- 1
- Primary Endpoint
- Treatment Completion Rates
- Status
- Completed
- Last Updated
- 6 years ago
Overview
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.
Investigators
Sabine Wilhelm, PhD
Sabine Wilhelm, Ph.D., Chief of Psychology
Massachusetts General Hospital
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)
Outcomes
Primary Outcomes
Treatment Completion Rates
Time Frame: Post treatment assessment (12 weeks)
Number of subjects who completed the app-based treatment to assess feasibility and acceptability
Client Satisfaction Questionnaire (CSQ). This Measure Will be Used to Assess Change Over the Course of Treatment Twice Throughout the Study (Over Approximately 10 Months Total).
Time Frame: Post-treatment assessment (week 12)
The Client Satisfaction Questionnaire (CSQ) is a 25-item self-report questionnaire which assesses the satisfaction with clinical services received. Total scores range from 8 to 32, with the higher number indicating greater satisfaction.
Secondary Outcomes
- Yale Brown Obsessive Compulsive Scale Modified for BDD (BDD-YBOCS). This Measure Will be Used to Assess Change Over the Course of Treatment at Five Time Points Throughout the Study (Over Approximately 10 Months Total).(Post-treatment assessment (week 12))