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

Somatoform Disorders Clinical Trial

Official title:

A Randomized Waitlist Controlled Treatment Trial Investigating CBT for Body Dysmorphic Disorder

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00106223
• Other study ID #: R34MH070490
• Secondary ID: R34MH0704902004-
• Status: Completed
• Phase: N/A
• First received: March 21, 2005
• Last updated: January 3, 2012
• Start date: April 2004
• Est. completion date: December 2008

Study information

• Verified date: January 2012
• Source: Massachusetts General Hospital
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Federal Government
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 36
• Est. completion date: December 2008
• Est. primary completion date: December 2008
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Body Dysmorphic Disorder
• Body Dysmorphic Disorders
• Disease
• Somatoform Disorders

Intervention

Behavioral:
• Cognitive behavioral therapy (CBT)
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.

Locations

Country	Name	City	State
United States	BDD Clinic, Massachusetts General Hospital	Charlestown	Massachusetts
United States	Body Image Program, Butler Hospital	Providence	Rhode Island

Sponsors (2)

Lead Sponsor	Collaborator
Massachusetts General Hospital	National Institute of Mental Health (NIMH)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Body dysmorphic disorder symptoms		Measured at Months 6 and 9	No
Secondary	Functioning and life satisfaction		Measured at Months 6 and 9	No
Secondary	Depressive symptoms		Measured at Months 6 and 9	Yes
Secondary	Anxiety symptoms		Measured at Months 6 and 9	No

External Links

•   Click here for information on the Body Dysmorphic Disorder Clinic, Massachusetts General Hospital Web site
•   Click here for information on the Body Image Program, Butler Hospital Web site