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

This study has been completed.
Sponsor:
Collaborator:
Information provided by (Responsible Party):
Sabine Wilhelm, Massachusetts General Hospital
ClinicalTrials.gov Identifier:
NCT00106223
First received: March 21, 2005
Last updated: January 3, 2012
Last verified: January 2012
  Purpose

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.


Condition Intervention
Body Dysmorphic Disorder
Somatoform Disorders
Behavioral: Cognitive behavioral therapy (CBT)

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: A Randomized Waitlist Controlled Treatment Trial Investigating CBT for Body Dysmorphic Disorder

Further study details as provided by Massachusetts General Hospital:

Primary Outcome Measures:
  • Body dysmorphic disorder symptoms [ Time Frame: Measured at Months 6 and 9 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Functioning and life satisfaction [ Time Frame: Measured at Months 6 and 9 ] [ Designated as safety issue: No ]
  • Depressive symptoms [ Time Frame: Measured at Months 6 and 9 ] [ Designated as safety issue: Yes ]
  • Anxiety symptoms [ Time Frame: Measured at Months 6 and 9 ] [ Designated as safety issue: No ]

Enrollment: 36
Study Start Date: April 2004
Study Completion Date: December 2008
Primary Completion Date: December 2008 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 1
Group receiving immediate treatment with cognitive behavioral therapy
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.
Other Name: CBT
Active Comparator: 2
Waitlist control group to begin CBT 3 months after other CBT group begins treatment
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.
Other Name: CBT

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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00106223

Locations
United States, Massachusetts
BDD Clinic, Massachusetts General Hospital
Charlestown, Massachusetts, United States, 02129
United States, Rhode Island
Body Image Program, Butler Hospital
Providence, Rhode Island, United States, 02906
Sponsors and Collaborators
Massachusetts General Hospital
Investigators
Principal Investigator: Sabine Wilhelm, PhD BDD Clinic Director, Massachusetts General Hospital
  More Information

Additional Information:
No publications provided

Responsible Party: Sabine Wilhelm, PhD, Massachusetts General Hospital
ClinicalTrials.gov Identifier: NCT00106223     History of Changes
Other Study ID Numbers: R34 MH070490, R34MH070490, 2004-P-000478/7, DATR A2-AIR
Study First Received: March 21, 2005
Last Updated: January 3, 2012
Health Authority: United States: Federal Government

Keywords provided by Massachusetts General Hospital:
Cognitive Behavioral Therapy
CBT
BDD
Body dysmorphic disorder

Additional relevant MeSH terms:
Body Dysmorphic Disorders
Disease
Somatoform Disorders
Mental Disorders
Pathologic Processes

ClinicalTrials.gov processed this record on October 20, 2014