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

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Mass General Brigham

Status

Completed

Conditions

Somatoform Disorders
Body Dysmorphic Disorder

Treatments

Behavioral: Cognitive behavioral therapy (CBT)

Study type

Interventional

Funder types

Other
NIH

Identifiers

NCT00106223
R34MH070490 (U.S. NIH Grant/Contract)
DATR A2-AIR
2004-P-000478/7

Details and patient eligibility

About

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.

Full 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.

Enrollment

36 patients

Sex

All

Ages

18+ years old

Volunteers

No 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

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

None (Open label)

36 participants in 2 patient groups

1
Experimental group
Description:
Group receiving immediate treatment with cognitive behavioral therapy
Treatment:
Behavioral: Cognitive behavioral therapy (CBT)
2
Active Comparator group
Description:
Waitlist control group to begin CBT 3 months after other CBT group begins treatment
Treatment:
Behavioral: Cognitive behavioral therapy (CBT)

Trial contacts and locations

2

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Data sourced from clinicaltrials.gov

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