Cognitive-Behavioral Therapy for Pediatric Body Dysmorphic Disorder

An Open Trial of Cognitive-Behavioral Therapy (CBT) for Pediatric Body Dysmorphic Disorder (BDD)

The purpose of this study is to develop and test the effectiveness of Cognitive-Behavioral Therapy (CBT) for children and adolescents suffering from Body Dysmorphic Disorder.

Study Overview

• Status: Completed
• Conditions: Body Dysmorphic Disorder
• Intervention / Treatment: Behavioral: Cognitive-Behavioral Therapy

Detailed Description

The main purpose of this trial is to develop and investigate the effects of a CBT protocol for children and adolescents with BDD. It is important to investigate CBT in this population given the disorder's early onset and poor trajectory if left untreated.

In the first phase of this trial, we will develop the treatment manual, adapting the adult manual for use in a pediatric population. In the second phase of this trial we will test the effectiveness of the CBT treatment in 12 pediatric BDD patients. We intend to treat 12 children and adolescents with BDD. All patients will receive CBT. We will also examine treatment feasibility and acceptability (e.g., retention and reasons for treatment refusal and dropout, expectancy, and motivation), and we will explore predictors of outcome. Therapeutic progress will be broadly assessed with measures of beliefs, behaviors, mood, functioning, and quality of life before, during, and after treatment.

• Study Type: Interventional
• Enrollment (Actual): 13
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Massachusetts
    • Boston, Massachusetts, United States, 02114
      • Massachusetts General Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 10 years to 17 years (Child)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• Diagnosis of DSM-IV BDD or its delusional variant, which must be present currently and for at least 6 months prior to study entry
• Total score of at least 24 on the 12-item BDD-YBOCS, adolescent version, which includes a score of at least 2 on item 1 (1-3 hours/day of preoccupation with the perceived defect)
• Score of at least moderate on the Clinical Global Impressions of Severity (CGI-Severity)
• Score of < 60 on the Child Global Assessment Scale (C-GAS)
• Ability to communicate meaningfully with the investigators and competent to provide written assent; both parental informed consent and adolescent assent must be obtained

Exclusion Criteria:

• Alcohol or substance abuse or dependence within the past 3 months, bipolar disorder, psychosis, organic mental disorder, development disorder, body image concerns accounted for primarily by an eating disorder or weight concerns. If subjects have another comorbid diagnosis, the BDD has to be the primary concern.
• Recent (within the past 6 months) suicide attempt, or suicidal ideation as indicated by a K-SADS score of 4 or higher that is active or warrants consideration of hospitalization
• Need for inpatient or partial hospital treatment
• Current psychotherapy and failure to benefit from ten or more sessions of previous CBT treatment
• Participants can be receiving psychotropic medication, but they must be on a stable dose for 2 months prior to the study baseline assessment and maintain this dosage throughout the course of the study

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Cognitive-Behavioral Therapy	Behavioral: Cognitive-Behavioral Therapy; 20 sessions of Cognitive-Behavioral Therapy

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Yale-Brown Obsessive Compulsive Scale Modified for BDD (BDD-YBOCS)-Pediatric Version	Baseline, Monthly, Post-Treatment, 3-Month Follow-Up, 6-Month Follow-Up

Secondary Outcome Measures

Outcome Measure	Time Frame
Brown Assessment of Beliefs Scale (BABS)-Pediatric Version	Baseline, Monthly, Post-Treatment, 3-Month Follow-Up, 6-Month Follow-Up
Clinical Global Impression Scale (CGI)	Baseline, Monthly, Post-Treatment, 3-Month Follow-Up, 6-Month Follow-Up
Children's Depression Inventory (CDI)	Baseline, Weekly, Post-Treatment, 3-Month Follow-Up, 6-Month Follow-Up

Collaborators and Investigators

• Sponsor: Massachusetts General Hospital
• Investigators: Study Director: Jennifer Greenberg, Psy.D., Massachusetts General Hospital

Study record dates

Study Major Dates

• Study Start: June 1, 2009
• Primary Completion (Actual): August 1, 2015
• Study Completion (Actual): August 1, 2015

Study Registration Dates

• First Submitted: October 26, 2009
• First Submitted That Met QC Criteria: October 26, 2009
• First Posted (Estimate): October 27, 2009

Study Record Updates

• Last Update Posted (Estimate): March 16, 2016
• Last Update Submitted That Met QC Criteria: March 15, 2016
• Last Verified: March 1, 2016

More Information

Terms related to this study

• Keywords: Pediatric; CBT; Cognitive-Behavioral Therapy; Body Dysmorphic Disorder; BDD
• Additional Relevant MeSH Terms: Mental Disorders; Pathologic Processes; Somatoform Disorders; Disease; Body Dysmorphic Disorders
• Other Study ID Numbers: 2008P002270