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

NCT ID: NCT00106223

Last Updated: 2012-01-05

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 36 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2004-04-30
• Study Completion Date: 2008-12-31

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.

Conditions

Body Dysmorphic Disorder; Somatoform Disorders

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

1

Group receiving immediate treatment with cognitive behavioral therapy

Group Type: EXPERIMENTAL

Cognitive behavioral therapy (CBT)

Intervention Type: BEHAVIORAL

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.

2

Waitlist control group to begin CBT 3 months after other CBT group begins treatment

Group Type: ACTIVE_COMPARATOR

Cognitive behavioral therapy (CBT)

Intervention Type: BEHAVIORAL

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.

Interventions

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.

Intervention Type: BEHAVIORAL

Other Intervention Names

CBT

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

National Institute of Mental Health (NIMH)

NIH

Sponsor Role: collaborator

Massachusetts General Hospital

OTHER

Sponsor Role: lead

Responsible Party

Sabine Wilhelm

PhD

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Sabine Wilhelm, PhD

Role: PRINCIPAL_INVESTIGATOR

BDD Clinic Director, Massachusetts General Hospital

Locations

BDD Clinic, Massachusetts General Hospital

Charlestown, Massachusetts, United States

Body Image Program, Butler Hospital

Providence, Rhode Island, United States

Countries

United States

References

Fang A, Steketee G, Keshaviah A, Didie E, Phillips KA, Wilhelm S. Mechanisms of Change in Cognitive Behavioral Therapy for Body Dysmorphic Disorder. Cognit Ther Res. 2020 Jun;44(3):596-610. doi: 10.1007/s10608-020-10080-w. Epub 2020 Feb 4.

Reference Type: DERIVED

PMID: 38031584 (View on PubMed)

Related Links

http://www.massgeneral.org/bdd

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

Other Identifiers

R34MH070490

Identifier Type: NIH

Identifier Source: secondary_id

View Link

2004-P-000478/7

Identifier Type: -

Identifier Source: secondary_id

DATR A2-AIR

Identifier Type: -

Identifier Source: secondary_id

R34MH070490

Identifier Type: NIH

Identifier Source: org_study_id

View Link