Treatment Study Investigating New Cognitive Behavioral Therapy Treatment Manual for Body Dysmorphic Disorder

Not Applicable

Completed

• Conditions: Body Dysmorphic Disorder; Somatoform Disorders
• Interventions: Behavioral: Cognitive behavioral therapy (CBT)

• Registration Number: NCT00106223
• Lead Sponsor: Massachusetts General Hospital

Brief Summary

In an earlier phase of this study, a cognitive behavioral therapy (CBT) manual to treat body dysmorphic disorder (BDD) symptoms was developed. We are currently implementing this manual-based treatment to validate its effectiveness in patients with BDD.

Detailed Description

BDD is a disease that involves preoccupation with imagined or minor physical flaws. The condition often begins in adolescence and, if left untreated, can cause significant social, emotional, and occupational distress. Within the last decade, BDD has received increased attention, and various modes of treatment have been utilized and evaluated. CBT has been found to be a more effective form of treatment than other types of psychotherapy. In this study, we have created a new CBT treatment manual and are currently implementing it to evaluate its effectiveness in patients with BDD. The utility of this manual for different populations will also be evaluated, and adherence and competence measures to assess CBT delivery will be developed.

This study will last 24 weeks. Participants will be randomly assigned (like the flip of a coin) to either start CBT treatment immediately or to a waitlist group, which would require a 3-month wait without treatment before beginning treatment for this study. Participants have a 50-50 chance of being in either group. Participants will receive a total of 22 sessions of individual, manual-based CBT. The CBT sessions will occur weekly during the course of the study. During the sessions, participants will receive education about BDD and CBT, engage in activities that help them confront their BDD, learn new ways of thinking about body image, and learn relapse prevention techniques. Self-report scales will be used to assess participants.

Study Timeline

• Study Start: 2004-04
• Study First Submitted: 2005-03-21
• Study First Submitted QC: 2005-03-21
• Study First Posted: 2005-03-22
• Primary Completion: 2008-12
• Study Completion: 2008-12
• Status Verified: 2012-01
• Last Update Submitted: 2012-01-03
• Last Update Posted: 2012-01-05

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 36

Inclusion Criteria

• DSM-IV diagnosis of BDD for at least 6 months prior to study entry
• Score higher than 23 on BDD Yale-Brown Obsessive Compulsive Scale
• Live within driving distance of Boston, MA or Providence, RI

Exclusion Criteria

• Any psychiatric diagnoses other than BDD
• Alcohol abuse or dependence within 3 months prior to study entry
• Suicidal or homicidal
• Psychotropic medication within 2 months prior to study entry

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
1	Cognitive behavioral therapy (CBT)	Group receiving immediate treatment with cognitive behavioral therapy
2	Cognitive behavioral therapy (CBT)	Waitlist control group to begin CBT 3 months after other CBT group begins treatment

Primary Outcome Measures

Name	Time	Method
Body dysmorphic disorder symptoms	Measured at Months 6 and 9

Secondary Outcome Measures

Name	Time	Method
Depressive symptoms	Measured at Months 6 and 9
Functioning and life satisfaction	Measured at Months 6 and 9
Anxiety symptoms	Measured at Months 6 and 9

Trial Locations

Locations (2)

Body Image Program, Butler Hospital; 🇺🇸 Providence, Rhode Island, United States

BDD Clinic, Massachusetts General Hospital; 🇺🇸 Charlestown, Massachusetts, United States