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Waitlist-Control Trial of Smartphone Cognitive Behavioral Therapy (CBT) for Body Dysmorphic Disorder (BDD)

Primary Purpose

Body Dysmorphic Disorder

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Smartphone-delivered cognitive behavioral therapy (CBT) for body dysmorphic disorder (BDD)
Sponsored by
Massachusetts General Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Body Dysmorphic Disorder

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • at least 18 years of age
  • current diagnosis of primary body dysmorphic disorder (BDD), based on a clinical structured diagnostic interview
  • 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 cognitive behavioral therapy (CBT) for body dysmorphic disorder (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 Columbia-Suicide Severity Rating Scale (C-SSRS).
  • Current severe comorbid major depression, as indicated by clinical judgment and/or a Quick Inventory of Depressive Symptomatology- Self Report (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 cognitive behavioral therapy (CBT) for body dysmorphic disorder (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

Secondary Outcome Measures

Difference in Depression at the End of Treatment/Waitlist Period
The self-report Quick Inventory of Depressive Symptomatology (QIDS-SR) is a measure of depressive symptoms consisting of 16 scale items with responses ranging from 0 to 3, including one suicide item (item #12). Total scores have a range from 0 to 27 with higher scores indicating greater depression severity. The measure is a well-validated, sensitive measure of symptom severity in depression.
Difference in Delusionality at the End of Treatment/Waitlist Period
Delusionality was 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; the first six items 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
Functional impairment was measured using the Sheehan Disability Scale (SDS). The SDS is a self-rated, 3-item questionnaire that uses a Likert scale from 0 (not at all) to 10 (extremely) to assess impairment in occupational, social, and family domains. The 3 items are summed for a total score (range: 0-30), where higher scores indicate greater functional impairment.
Difference in Quality of Life at the End of Treatment/Waitlist Period
Quality of life was assessed using The Quality of Life, Enjoyment, and Satisfaction Questionnaire - Short Form (Q-LES-Q-SF). The Q-LES-Q-SF is a 16-item 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

First Posted
September 11, 2018
Last Updated
October 3, 2022
Sponsor
Massachusetts General Hospital
Collaborators
Koa Health B.V.
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1. Study Identification

Unique Protocol Identification Number
NCT03673046
Brief Title
Waitlist-Control Trial of Smartphone Cognitive Behavioral Therapy (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
October 2022
Overall Recruitment Status
Completed
Study Start Date
September 17, 2019 (Actual)
Primary Completion Date
June 17, 2021 (Actual)
Study Completion Date
October 3, 2022 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Massachusetts General Hospital
Collaborators
Koa Health B.V.

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 body dysmorphic disorder symptom severity 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 cognitive behavioral therapy (CBT) treatment for adults with body dysmorphic disorder (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 Disorder

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
80 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Smartphone-delivered cognitive behavioral therapy (CBT) for body dysmorphic disorder (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 cognitive behavioral therapy (CBT) for body dysmorphic disorder (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
Time Frame
Week 0, Week 6, and Week 12
Secondary Outcome Measure Information:
Title
Difference in Depression at the End of Treatment/Waitlist Period
Description
The self-report Quick Inventory of Depressive Symptomatology (QIDS-SR) is a measure of depressive symptoms consisting of 16 scale items with responses ranging from 0 to 3, including one suicide item (item #12). Total scores have a range from 0 to 27 with higher scores indicating greater depression severity. The measure is a well-validated, sensitive measure of symptom severity in depression.
Time Frame
Week 0, Week 6, and Week 12
Title
Difference in Delusionality at the End of Treatment/Waitlist Period
Description
Delusionality was 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; the first six items are summed to generate a total score (range: 0-24). Higher scores indicate greater delusionality.
Time Frame
Week 0, Week 6, and Week 12
Title
Difference in Functional Impairment at the End of Treatment/Waitlist Period
Description
Functional impairment was measured using the Sheehan Disability Scale (SDS). The SDS is a self-rated, 3-item questionnaire that uses a Likert scale from 0 (not at all) to 10 (extremely) to assess impairment in occupational, social, and family domains. The 3 items are summed for a total score (range: 0-30), where higher scores indicate greater functional impairment.
Time Frame
Week 0, Week 6, and Week 12
Title
Difference in Quality of Life at the End of Treatment/Waitlist Period
Description
Quality of life was assessed using The Quality of Life, Enjoyment, and Satisfaction Questionnaire - Short Form (Q-LES-Q-SF). The Q-LES-Q-SF is a 16-item 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
Week 0, Week 6, and 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 body dysmorphic disorder (BDD), based on a clinical structured diagnostic interview 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 cognitive behavioral therapy (CBT) for body dysmorphic disorder (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 Columbia-Suicide Severity Rating Scale (C-SSRS). Current severe comorbid major depression, as indicated by clinical judgment and/or a Quick Inventory of Depressive Symptomatology- Self Report (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 Cognitive Behavioral Therapy (CBT) for Body Dysmorphic Disorder (BDD)

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