NCT03221738

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
10

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Jul 2017

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

July 12, 2017

Completed
7 days until next milestone

First Posted

Study publicly available on registry

July 19, 2017

Completed
5 days until next milestone

Study Start

First participant enrolled

July 24, 2017

Completed
1.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 18, 2019

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 18, 2019

Completed
5 months until next milestone

Results Posted

Study results publicly available

June 26, 2019

Completed
Last Updated

June 26, 2019

Status Verified

April 1, 2019

Enrollment Period

1.5 years

First QC Date

July 12, 2017

Results QC Date

March 28, 2019

Last Update Submit

April 2, 2019

Conditions

Body Dysmorphic Disorders

Keywords

BDD

Outcome Measures

Primary Outcomes (2)

  • Treatment Completion Rates

    Number of subjects who completed the app-based treatment to assess feasibility and acceptability

    Post treatment assessment (12 weeks)

  • 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.

    Post-treatment assessment (week 12)

Secondary Outcomes (1)

  • 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).

    Post-treatment assessment (week 12)

Study Arms (1)

App-Based Cognitive Behavioral Therapy

EXPERIMENTAL

12-week Smartphone-delivered CBT for BDD.

Behavioral: App-Based Cognitive Behavioral Therapy

Interventions

App-Based Cognitive Behavioral TherapyBEHAVIORAL

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.

App-Based Cognitive Behavioral Therapy

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Massachusetts General Hospital

Boston, Massachusetts, 02114, United States

Location

Related Publications (1)

  • 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.

    PMID: 32005333DERIVED

MeSH Terms

Conditions

Body Dysmorphic Disorders

Condition Hierarchy (Ancestors)

Somatoform DisordersMental Disorders

Results Point of Contact

Title
Anna Schwartzberg
Organization
Massachusetts General Hospital
aschwartzberg@mgh.harvard.edu
617-724-7161

Study Officials

  • Sabine Wilhelm, Ph.D.

    Massachusetts General Hospital

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
No
Restrictive Agreement
No

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Sabine Wilhelm, Ph.D., Chief of Psychology

Study Record Dates

First Submitted

July 12, 2017

First Posted

July 19, 2017

Study Start

July 24, 2017

Primary Completion

January 18, 2019

Study Completion

January 18, 2019

Last Updated

June 26, 2019

Results First Posted

June 26, 2019

Record last verified: 2019-04

Data Sharing

IPD Sharing
Will not share

Locations

US(1)