search
Back to results

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

Primary Purpose

Body Dysmorphic Disorder, Somatoform Disorders

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Cognitive behavioral therapy (CBT)
Sponsored by
Massachusetts General Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Body Dysmorphic Disorder focused on measuring Cognitive Behavioral Therapy, CBT, BDD, Body dysmorphic disorder

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • BDD Clinic, Massachusetts General Hospital
  • Body Image Program, Butler Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

1

2

Arm Description

Group receiving immediate treatment with cognitive behavioral therapy

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

Outcomes

Primary Outcome Measures

Body dysmorphic disorder symptoms

Secondary Outcome Measures

Functioning and life satisfaction
Depressive symptoms
Anxiety symptoms

Full Information

First Posted
March 21, 2005
Last Updated
January 3, 2012
Sponsor
Massachusetts General Hospital
Collaborators
National Institute of Mental Health (NIMH)
search

1. Study Identification

Unique Protocol Identification Number
NCT00106223
Brief Title
Treatment Study Investigating New Cognitive Behavioral Therapy Treatment Manual for Body Dysmorphic Disorder
Official Title
A Randomized Waitlist Controlled Treatment Trial Investigating CBT for Body Dysmorphic Disorder
Study Type
Interventional

2. Study Status

Record Verification Date
January 2012
Overall Recruitment Status
Completed
Study Start Date
April 2004 (undefined)
Primary Completion Date
December 2008 (Actual)
Study Completion Date
December 2008 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Massachusetts General Hospital
Collaborators
National Institute of Mental Health (NIMH)

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Body Dysmorphic Disorder, Somatoform Disorders
Keywords
Cognitive Behavioral Therapy, CBT, BDD, Body dysmorphic disorder

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
36 (Actual)

8. Arms, Groups, and Interventions

Arm Title
1
Arm Type
Experimental
Arm Description
Group receiving immediate treatment with cognitive behavioral therapy
Arm Title
2
Arm Type
Active Comparator
Arm Description
Waitlist control group to begin CBT 3 months after other CBT group begins treatment
Intervention Type
Behavioral
Intervention Name(s)
Cognitive behavioral therapy (CBT)
Other Intervention Name(s)
CBT
Intervention Description
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.
Primary Outcome Measure Information:
Title
Body dysmorphic disorder symptoms
Time Frame
Measured at Months 6 and 9
Secondary Outcome Measure Information:
Title
Functioning and life satisfaction
Time Frame
Measured at Months 6 and 9
Title
Depressive symptoms
Time Frame
Measured at Months 6 and 9
Title
Anxiety symptoms
Time Frame
Measured at Months 6 and 9

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Sabine Wilhelm, PhD
Organizational Affiliation
BDD Clinic Director, Massachusetts General Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
BDD Clinic, Massachusetts General Hospital
City
Charlestown
State/Province
Massachusetts
ZIP/Postal Code
02129
Country
United States
Facility Name
Body Image Program, Butler Hospital
City
Providence
State/Province
Rhode Island
ZIP/Postal Code
02906
Country
United States

12. IPD Sharing Statement

Links:
URL
http://www.massgeneral.org/bdd
Description
Click here for information on the Body Dysmorphic Disorder Clinic, Massachusetts General Hospital Web site

Learn more about this trial

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

We'll reach out to this number within 24 hrs