- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03221738
Smartphone-Administered App Treatment for Adults With Body Dysmorphic Disorder
Development of a Cognitive Behavioral Mobile App for Body Dysmorphic Disorder, and Tests of Feasibility, Acceptability, and Preliminary Efficacy
Study Overview
Status
Conditions
Intervention / Treatment
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.
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
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Massachusetts
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Boston, Massachusetts, United States, 02114
- Massachusetts General Hospital
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
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
Study Plan
How is the study designed?
Design Details
- Primary Purpose: TREATMENT
- Allocation: NA
- Interventional Model: SINGLE_GROUP
- Masking: NONE
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
EXPERIMENTAL: App-Based Cognitive Behavioral Therapy
12-week Smartphone-delivered CBT for BDD.
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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 |
---|---|---|
Treatment Completion Rates
Time Frame: Post treatment assessment (12 weeks)
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Number of subjects who completed the app-based treatment to assess feasibility and acceptability
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Post treatment assessment (12 weeks)
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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)
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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.
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Post-treatment assessment (week 12)
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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).
Time Frame: Post-treatment assessment (week 12)
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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.
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Post-treatment assessment (week 12)
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Collaborators and Investigators
Sponsor
Collaborators
Publications and helpful links
Study record dates
Study Major Dates
Study Start (ACTUAL)
Primary Completion (ACTUAL)
Study Completion (ACTUAL)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (ACTUAL)
Study Record Updates
Last Update Posted (ACTUAL)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- 2017P000293_A
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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