Treatment Study Investigating New Cognitive Behavioral Therapy Treatment Manual for Body Dysmorphic Disorder
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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 |
- Body dysmorphic disorder symptoms [ Time Frame: Measured at Months 6 and 9 ] [ Designated as safety issue: No ]
- 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 |
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| 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 | |
| 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 Somatoform Disorders Mental Disorders |
ClinicalTrials.gov processed this record on May 19, 2013