NCT00106223

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

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
36

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Apr 2004

Longer than P75 for not_applicable

Geographic Reach
1 country

2 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

April 1, 2004

Completed
12 months until next milestone

First Submitted

Initial submission to the registry

March 21, 2005

Completed
1 day until next milestone

First Posted

Study publicly available on registry

March 22, 2005

Completed
3.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2008

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2008

Completed
Last Updated

January 5, 2012

Status Verified

January 1, 2012

Enrollment Period

4.7 years

First QC Date

March 21, 2005

Last Update Submit

January 3, 2012

Conditions

Keywords

Cognitive Behavioral TherapyCBTBDDBody dysmorphic disorder

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

EXPERIMENTAL

Group receiving immediate treatment with cognitive behavioral therapy

Behavioral: Cognitive behavioral therapy (CBT)

2

ACTIVE COMPARATOR

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

Behavioral: Cognitive behavioral therapy (CBT)

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.

Also known as: CBT
12

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

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

Location

Body Image Program, Butler Hospital

Providence, Rhode Island, 02906, United States

Location

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.

Related Links

MeSH Terms

Conditions

Body Dysmorphic DisordersSomatoform Disorders

Interventions

Cognitive Behavioral Therapy

Condition Hierarchy (Ancestors)

Mental Disorders

Intervention Hierarchy (Ancestors)

Behavior TherapyPsychotherapyBehavioral Disciplines and Activities

Study Officials

  • Sabine Wilhelm, PhD

    BDD Clinic Director, Massachusetts General Hospital

    PRINCIPAL INVESTIGATOR

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

Locations