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

This study has been completed.
Sponsor:
Collaborator:
National Institute of Mental Health (NIMH)
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
History of Changes

March 21, 2005
January 3, 2012
April 2004
December 2008   (final data collection date for primary outcome measure)
Body dysmorphic disorder symptoms [ Time Frame: Measured at Months 6 and 9 ] [ Designated as safety issue: No ]
Body dysmorphic disorder symptoms
Complete list of historical versions of study NCT00106223 on ClinicalTrials.gov Archive Site
  • 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 ]
  • Functioning and life satisfaction
  • Depressive symptoms
  • Anxiety symptoms
 
 
 
Treatment Study Investigating New Cognitive Behavioral Therapy Treatment Manual for Body Dysmorphic Disorder
A Randomized Waitlist Controlled Treatment Trial Investigating CBT for Body Dysmorphic Disorder

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.

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.
Interventional
 
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
  • Body Dysmorphic Disorder
  • Somatoform Disorders
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
  • Experimental: 1
    Group receiving immediate treatment with cognitive behavioral therapy
    Intervention: Behavioral: Cognitive behavioral therapy (CBT)
  • Active Comparator: 2
    Waitlist control group to begin CBT 3 months after other CBT group begins treatment
    Intervention: Behavioral: Cognitive behavioral therapy (CBT)
 

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
36
December 2008
December 2008   (final data collection date for primary outcome measure)

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
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00106223
R34 MH070490, R34MH070490, 2004-P-000478/7, DATR A2-AIR
Yes
Sabine Wilhelm, Massachusetts General Hospital
Massachusetts General Hospital
National Institute of Mental Health (NIMH)
Principal Investigator: Sabine Wilhelm, PhD BDD Clinic Director, Massachusetts General Hospital
Massachusetts General Hospital
January 2012

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP