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

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ClinicalTrials.gov Identifier: NCT00106223
Recruitment Status : Completed
First Posted : March 22, 2005
Last Update Posted : January 5, 2012
Sponsor:
Collaborator:
National Institute of Mental Health (NIMH)
Information provided by (Responsible Party):
Sabine Wilhelm, 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.

Condition or disease Intervention/treatment Phase
Body Dysmorphic Disorder Somatoform Disorders Behavioral: Cognitive behavioral therapy (CBT) Not Applicable

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 Type : Interventional  (Clinical Trial)
Actual Enrollment : 36 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Randomized Waitlist Controlled Treatment Trial Investigating CBT for Body Dysmorphic Disorder
Study Start Date : April 2004
Actual Primary Completion Date : December 2008
Actual Study Completion Date : December 2008

Arm Intervention/treatment
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



Primary Outcome Measures :
  1. Body dysmorphic disorder symptoms [ Time Frame: Measured at Months 6 and 9 ]

Secondary Outcome Measures :
  1. Functioning and life satisfaction [ Time Frame: Measured at Months 6 and 9 ]
  2. Depressive symptoms [ Time Frame: Measured at Months 6 and 9 ]
  3. Anxiety symptoms [ Time Frame: Measured at Months 6 and 9 ]


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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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
National Institute of Mental Health (NIMH)
Investigators
Principal Investigator: Sabine Wilhelm, PhD BDD Clinic Director, Massachusetts General Hospital

Additional Information:
Responsible Party: Sabine Wilhelm, PhD, Massachusetts General Hospital
ClinicalTrials.gov Identifier: NCT00106223     History of Changes
Other Study ID Numbers: R34MH070490 ( U.S. NIH Grant/Contract )
2004-P-000478/7
DATR A2-AIR
First Posted: March 22, 2005    Key Record Dates
Last Update Posted: January 5, 2012
Last Verified: January 2012

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

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