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
3 other identifiers
interventional
36
1 country
2
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for not_applicable
Started Apr 2004
Longer than P75 for not_applicable
2 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
April 1, 2004
CompletedFirst Submitted
Initial submission to the registry
March 21, 2005
CompletedFirst Posted
Study publicly available on registry
March 22, 2005
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 1, 2008
CompletedStudy Completion
Last participant's last visit for all outcomes
December 1, 2008
CompletedJanuary 5, 2012
January 1, 2012
4.7 years
March 21, 2005
January 3, 2012
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Body dysmorphic disorder symptoms
Measured at Months 6 and 9
Secondary Outcomes (3)
Functioning and life satisfaction
Measured at Months 6 and 9
Depressive symptoms
Measured at Months 6 and 9
Anxiety symptoms
Measured at Months 6 and 9
Study Arms (2)
1
EXPERIMENTALGroup receiving immediate treatment with cognitive behavioral therapy
2
ACTIVE COMPARATORWaitlist control group to begin CBT 3 months after other CBT group begins treatment
Interventions
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.
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (2)
BDD Clinic, Massachusetts General Hospital
Charlestown, Massachusetts, 02129, United States
Body Image Program, Butler Hospital
Providence, Rhode Island, 02906, United States
Related Publications (1)
Fang A, Steketee G, Keshaviah A, Didie E, Phillips KA, Wilhelm S. Mechanisms of Change in Cognitive Behavioral Therapy for Body Dysmorphic Disorder. Cognit Ther Res. 2020 Jun;44(3):596-610. doi: 10.1007/s10608-020-10080-w. Epub 2020 Feb 4.
PMID: 38031584DERIVED
Related Links
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Sabine Wilhelm, PhD
BDD Clinic Director, Massachusetts General Hospital
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- PhD
Study Record Dates
First Submitted
March 21, 2005
First Posted
March 22, 2005
Study Start
April 1, 2004
Primary Completion
December 1, 2008
Study Completion
December 1, 2008
Last Updated
January 5, 2012
Record last verified: 2012-01