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Treatment Study Investigating New Cognitive Behavioral Therapy Treatment Manual for Body Dysmorphic Disorder
This study has been completed.
First Received: March 21, 2005   Last Updated: March 19, 2009   History of Changes
Sponsor: National Institute of Mental Health (NIMH)
Information provided by: National Institute of Mental Health (NIMH)
ClinicalTrials.gov Identifier: NCT00106223
  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: Treatment, Randomized, Open Label, Uncontrolled, Parallel Assignment, Efficacy Study
Official Title: A Randomized Waitlist Controlled Treatment Trial Investigating CBT for Body Dysmorphic Disorder

Further study details as provided by National Institute of Mental Health (NIMH):

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
1: Experimental
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.
2: Active Comparator
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.

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
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
Investigators
Principal Investigator: Sabine Wilhelm, PhD BDD Clinic Director, Massachusetts General Hospital
  More Information

Additional Information:
No publications provided

Responsible Party: Massachusetts General Hospital/ Harvard Medical School ( Sabine Wilhelm PhD )
Study ID Numbers: R34 MH070490, 2004-P-000478/7, DATR A2-AIR
Study First Received: March 21, 2005
Last Updated: March 19, 2009
ClinicalTrials.gov Identifier: NCT00106223     History of Changes
Health Authority: United States: Federal Government

Keywords provided by National Institute of Mental Health (NIMH):
Cognitive Behavioral Therapy
CBT
BDD
Body dysmorphic disorder

Additional relevant MeSH terms:
Hypochondriasis
Pathologic Processes
Disease
Mental Disorders
Somatoform Disorders

ClinicalTrials.gov processed this record on February 08, 2010