Smartphone-Administered App Treatment for Adults With Body Dysmorphic Disorder

Study Overview
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Brief Summary
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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
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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.

Official Title
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Development of a Cognitive Behavioral Mobile App for Body Dysmorphic Disorder, and Tests of Feasibility, Acceptability, and Preliminary Efficacy

Conditions
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Body Dysmorphic Disorders

Intervention / Treatment
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* Behavioral: App-Based Cognitive Behavioral Therapy


Participation Criteria
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Eligibility Criteria
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Phase 1B (open pilot trial): 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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: App-Based Cognitive Behavioral Therapy<br>12-week Smartphone-delivered CBT for BDD. | Behavioral: App-Based Cognitive Behavioral Therapy<br>* 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.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Treatment Completion Rates | Number of subjects who completed the app-based treatment to assess feasibility and acceptability | Post treatment assessment (12 weeks) | 
| 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). | 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. | Post-treatment assessment (week 12) | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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). | The 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. | Post-treatment assessment (week 12) | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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BDD