Smartphone-Administered App Treatment for Adults With Body Dysmorphic Disorder
Primary Purpose
Body Dysmorphic Disorders
Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
App-Based Cognitive Behavioral Therapy
Sponsored by
About this trial
This is an interventional treatment trial for Body Dysmorphic Disorders focused on measuring BDD
Eligibility Criteria
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
Sites / Locations
- Massachusetts General Hospital
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
App-Based Cognitive Behavioral Therapy
Arm Description
12-week Smartphone-delivered CBT for BDD.
Outcomes
Primary Outcome Measures
Treatment Completion Rates
Number of subjects who completed the app-based treatment to assess feasibility and acceptability
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.
Secondary Outcome Measures
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.
Full Information
NCT ID
NCT03221738
First Posted
July 12, 2017
Last Updated
April 2, 2019
Sponsor
Massachusetts General Hospital
Collaborators
Telefónica S.A.
1. Study Identification
Unique Protocol Identification Number
NCT03221738
Brief Title
Smartphone-Administered App Treatment for Adults With Body Dysmorphic Disorder
Official Title
Development of a Cognitive Behavioral Mobile App for Body Dysmorphic Disorder, and Tests of Feasibility, Acceptability, and Preliminary Efficacy
Study Type
Interventional
2. Study Status
Record Verification Date
April 2019
Overall Recruitment Status
Completed
Study Start Date
July 24, 2017 (Actual)
Primary Completion Date
January 18, 2019 (Actual)
Study Completion Date
January 18, 2019 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Massachusetts General Hospital
Collaborators
Telefónica S.A.
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes
5. Study Description
Brief Summary
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
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Body Dysmorphic Disorders
Keywords
BDD
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
10 (Actual)
8. Arms, Groups, and Interventions
Arm Title
App-Based Cognitive Behavioral Therapy
Arm Type
Experimental
Arm Description
12-week Smartphone-delivered CBT for BDD.
Intervention Type
Behavioral
Intervention Name(s)
App-Based Cognitive Behavioral Therapy
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
Treatment Completion Rates
Description
Number of subjects who completed the app-based treatment to assess feasibility and acceptability
Time Frame
Post treatment assessment (12 weeks)
Title
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).
Description
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.
Time Frame
Post-treatment assessment (week 12)
Secondary Outcome Measure Information:
Title
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).
Description
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.
Time Frame
Post-treatment assessment (week 12)
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Sabine Wilhelm, Ph.D.
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
Plan to Share IPD
No
Citations:
PubMed Identifier
32005333
Citation
Wilhelm S, Weingarden H, Greenberg JL, McCoy TH, Ladis I, Summers BJ, Matic A, Harrison O. Development and Pilot Testing of a Cognitive-Behavioral Therapy Digital Service for Body Dysmorphic Disorder. Behav Ther. 2020 Jan;51(1):15-26. doi: 10.1016/j.beth.2019.03.007. Epub 2019 Aug 7.
Results Reference
derived
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Smartphone-Administered App Treatment for Adults With Body Dysmorphic Disorder
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