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

Study Overview
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Brief Summary
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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
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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.

Official Title
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A Randomized Waitlist Controlled Treatment Trial Investigating CBT for Body Dysmorphic Disorder

Conditions
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Body Dysmorphic Disorder, Somatoform Disorders

Intervention / Treatment
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* Behavioral: Cognitive behavioral therapy (CBT)


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: 1<br>Group receiving immediate treatment with cognitive behavioral therapy | Behavioral: Cognitive behavioral therapy (CBT)<br>* 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.<br>* Other names: CBT;|
| Active Comparator: 2<br>Waitlist control group to begin CBT 3 months after other CBT group begins treatment | Behavioral: Cognitive behavioral therapy (CBT)<br>* 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.<br>* Other names: CBT;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Body dysmorphic disorder symptoms |  | Measured at Months 6 and 9 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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CBT, Cognitive Behavioral Therapy, BDD, Body dysmorphic disorder