Waitlist-Control Trial of Smartphone CBT for Body Dysmorphic Disorder (BDD)
Study Details
Study Description
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 BDD-YBOCS scores than those in the waitlist condition at treatment endpoint (week 12).
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
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N/A |
Detailed Description
The primary aim of this study is to test the efficacy of a Smartphone-based CBT treatment for adults with BDD recruited nationally. In a prior study (Clinical Trials Identifier # NCT03221738), the investigators developed and pilot-tested the feasibility, acceptability, and preliminary efficacy of a CBT for BDD app in an open pilot trial. The investigators are now further testing these outcomes in a randomized controlled trial. Eligible subjects (N= 64) will be randomly assigned to 12-weeks of Smartphone-delivered CBT for BDD either immediately, or after a 12-week long waiting period (50/50 chance).
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Experimental: Smartphone-delivered CBT for BDD 12-week Smartphone-delivered CBT for BDD. |
Device: Smartphone-delivered CBT for BDD
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.
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| Other: 12 Week Waitlist Control 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 CBT for BDD
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.
|
Outcome Measures
Primary Outcome Measures
- Difference in BDD severity (BDD-YBOCS) at the end of treatment/waitlist period. [Endpoint (week 12)]
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 will be used to assess change in BDD symptoms from baseline to endpoint.
Secondary Outcome Measures
- Difference in depression at the end of treatment/waitlist period [Endpoint (week 12)]
Participants who receive app-CBT will have greater improvement on depression (QIDS-SR). The QIDS-SR is a self-report measure of depressive symptoms consisting of 16 scale items with responses ranging from 0 to 3, including one suicide item (item #12). Higher scores correspond with greater depression severity, and the measure is a well-validated, sensitive measure of symptom severity in depression.
- Difference in delusionality at the end of treatment/waitlist period [Endpoint (week 12)]
Participants who receive app-CBT will have greater improvement on delusionality, assessed using the Brown Assessment of Beliefs Scale (BABS).The BABS is a semi-structured, clinician-administered interview that assesses delusional thinking related to one's appearance concerns. It contains 7 items ranging from 0-4, which are summed to generate a total score (range= 0-24). Higher scores indicate greater delusionality.
- Difference in functional impairment at the end of treatment/waitlist period [Endpoint (week 12)]
Participants who receive app-CBT will have greater improvement on functional impairment (SDS). The SDS uses a Likert scale from 0 (not at all) to 10 (extremely) to assess impairment in occupational, social, and family domains. Higher scores indicate greater impairment.
- Difference in quality of life at the end of treatment/waitlist period [Endpoint (week 12)]
Participants who receive app-CBT will have greater improvement on quality of life, assessed using The Quality of Life, Enjoyment, and Satisfaction Questionnaire - Short Form (Q-LES-Q). The Q-LES-Q-SF is a self-report measure of subjective quality of life, containing Likert items ranging from 1 (Very Poor) to 5 (Very Good). Total scores are presented as a percentage of the maximum value (i.e., ranging from 0 to 100, with higher scores indicating greater quality of life).
Eligibility Criteria
Criteria
Inclusion Criteria:
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at least 18 years of age
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current diagnosis of primary DSM-5 BDD, based on MINI
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currently living in the United States
Exclusion Criteria:
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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)
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Past participation in 4+ sessions of CBT for BDD
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Current severe substance use disorder
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Lifetime bipolar disorder or psychosis
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Acute, active suicidal ideation as indicated by clinical judgment and/or a score >2 on the suicidal ideation subscale of the C-SSRS.
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Current severe comorbid major depression, as indicated by clinical judgment and/or a QIDS-SR total score ≥ 21
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Concurrent psychological treatment
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Does not own a supported Smartphone with a data plan
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Lack of technology literacy that would interfere with ability to engage with smartphone treatment
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Massachusetts General Hospital | Boston | Massachusetts | United States | 02114 |
Sponsors and Collaborators
- Massachusetts General Hospital
- Telefónica S.A.
Investigators
- Principal Investigator: Sabine Wilhelm, PhD, Massachusetts General Hospital
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- 2017P000293_B