Clinical trial NCT00106223: 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
Overall status: COMPLETED
Phase: NA
Conditions: Body Dysmorphic Disorder
Somatoform Disorders
Keywords: Cognitive Behavioral Therapy
CBT
BDD
Body dysmorphic disorder
Lead sponsor: Massachusetts General Hospital
Sponsor class: OTHER
Collaborators: name: National Institute of Mental Health (NIMH)
First posted: 2005-03-22
Enrollment: 36
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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

Primary outcomes:
measure: Body dysmorphic disorder symptoms
timeFrame: Measured at Months 6 and 9
Secondary outcomes:
measure: Functioning and life satisfaction
timeFrame: Measured at Months 6 and 9
measure: Depressive symptoms
timeFrame: Measured at Months 6 and 9
measure: Anxiety symptoms
timeFrame: Measured at Months 6 and 9
Other outcomes:
Locations:
city: Charlestown
country: United States
facility: BDD Clinic, Massachusetts General Hospital
state: Massachusetts
city: Providence
country: United States
facility: Body Image Program, Butler Hospital
state: Rhode Island
Study officials:
affiliation: BDD Clinic Director, Massachusetts General Hospital
name: Sabine Wilhelm, PhD
role: PRINCIPAL_INVESTIGATOR
References: