Back to resultsWaitlist-Control Trial of Smartphone CBT for Body Dysmorphic Disorder (BDD)
Primary Purpose
Body Dysmorphic Disorders
Status
Active
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Smartphone-delivered CBT for BDD
Sponsored by
About this trial
This is an interventional treatment trial for Body Dysmorphic Disorders
Eligibility Criteria
Inclusion Criteria:
- At least 18 years of age
- Current diagnosis of primary DSM-5 BDD, based on MINI
- Currently living in the United States
Exclusion Criteria:
- 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)
- Past participation in 4+ sessions of CBT for BDD
- Current severe substance use disorder
- Lifetime bipolar disorder or psychosis
- Acute, active suicidal ideation as indicated by clinical judgment and/or a score >2 on the suicidal ideation subscale of the C-SSRS.
- Current severe comorbid major depression, as indicated by clinical judgment and/or a QIDS-SR total score ≥ 21
- Concurrent psychological treatment
- Does not own a supported Smartphone with a data plan
- Lack of technology literacy that would interfere with ability to engage with smartphone treatment
Sites / Locations
- Massachusetts General Hospital
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Other
Arm Label
Smartphone-delivered CBT for BDD
12 Week Waitlist Control
Arm Description
12-week Smartphone-delivered CBT for BDD.
12 week waitlist control. (Note: participants will be crossed over to 12-week Smartphone-delivered CBT for BDD following the 12-week waitlist control).
Outcomes
Primary Outcome Measures
Difference in BDD severity (BDD-YBOCS) at the end of treatment/waitlist period.
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
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
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
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
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).
Full Information
NCT ID
NCT04034693
First Posted
July 24, 2019
Last Updated
April 26, 2021
Sponsor
Koa Health B.V.
Collaborators
Massachusetts General Hospital
1. Study Identification
Unique Protocol Identification Number
NCT04034693
Brief Title
Waitlist-Control Trial of Smartphone CBT for Body Dysmorphic Disorder (BDD)
Official Title
Smartphone Cognitive Behavioral Therapy for Body Dysmorphic Disorder: A Randomized, Waitlist-control Trial
Study Type
Interventional
2. Study Status
Record Verification Date
April 2021
Overall Recruitment Status
Active, not recruiting
Study Start Date
August 12, 2019 (Actual)
Primary Completion Date
January 15, 2022 (Anticipated)
Study Completion Date
January 15, 2022 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Koa Health B.V.
Collaborators
Massachusetts General Hospital
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
Yes
Device Product Not Approved or Cleared by U.S. FDA
Yes
Product Manufactured in and Exported from the U.S.
No
Data Monitoring Committee
Yes
5. 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).
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).
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Body Dysmorphic Disorders
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Crossover Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
80 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Smartphone-delivered CBT for BDD
Arm Type
Experimental
Arm Description
12-week Smartphone-delivered CBT for BDD.
Arm Title
12 Week Waitlist Control
Arm Type
Other
Arm Description
12 week waitlist control. (Note: participants will be crossed over to 12-week Smartphone-delivered CBT for BDD following the 12-week waitlist control).
Intervention Type
Device
Intervention Name(s)
Smartphone-delivered CBT for BDD
Intervention Description
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.
Primary Outcome Measure Information:
Title
Difference in BDD severity (BDD-YBOCS) at the end of treatment/waitlist period.
Description
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.
Time Frame
Endpoint (week 12)
Secondary Outcome Measure Information:
Title
Difference in depression at the end of treatment/waitlist period
Description
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.
Time Frame
Endpoint (week 12)
Title
Difference in delusionality at the end of treatment/waitlist period
Description
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.
Time Frame
Endpoint (week 12)
Title
Difference in functional impairment at the end of treatment/waitlist period
Description
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.
Time Frame
Endpoint (week 12)
Title
Difference in quality of life at the end of treatment/waitlist period
Description
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).
Time Frame
Endpoint (week 12)
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
At least 18 years of age
Current diagnosis of primary DSM-5 BDD, based on MINI
Currently living in the United States
Exclusion Criteria:
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)
Past participation in 4+ sessions of CBT for BDD
Current severe substance use disorder
Lifetime bipolar disorder or psychosis
Acute, active suicidal ideation as indicated by clinical judgment and/or a score >2 on the suicidal ideation subscale of the C-SSRS.
Current severe comorbid major depression, as indicated by clinical judgment and/or a QIDS-SR total score ≥ 21
Concurrent psychological treatment
Does not own a supported Smartphone with a data plan
Lack of technology literacy that would interfere with ability to engage with smartphone treatment
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Sabine Wilhelm, PhD
Organizational Affiliation
Massachusetts General Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Massachusetts General Hospital
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02114
Country
United States
12. IPD Sharing Statement
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Waitlist-Control Trial of Smartphone CBT for Body Dysmorphic Disorder (BDD)
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