Smartphone-Administered App Treatment for Adults With Body Dysmorphic Disorder

Body Dysmorphic Disorders Clinical Trial

Official title:

Development of a Cognitive Behavioral Mobile App for Body Dysmorphic Disorder, and Tests of Feasibility, Acceptability, and Preliminary Efficacy

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03221738
• Other study ID #: 2017P000293_A
• Status: Completed
• Phase: N/A
• Start date: July 24, 2017
• Est. completion date: January 18, 2019

Study information

• Verified date: April 2019
• Source: Massachusetts General Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 10
• Est. completion date: January 18, 2019
• Est. primary completion date: January 18, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Body Dysmorphic Disorders
• Disease

Intervention

Behavioral:
• App-Based Cognitive Behavioral Therapy
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.

Locations

Country	Name	City	State
United States	Massachusetts General Hospital	Boston	Massachusetts

Sponsors (2)

Lead Sponsor	Collaborator
Massachusetts General Hospital	Telefónica S.A.

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Treatment Completion Rates	Number of subjects who completed the app-based treatment to assess feasibility and acceptability	Post treatment assessment (12 weeks)
Primary	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	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.	Post-treatment assessment (week 12)