Cognitive-Behavioral Therapy for Pediatric Body Dysmorphic Disorder

NCT01002326 | Completed

• 1 other identifier: 2008P002270
• Study Type: interventional
• Target: 13
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Body Dysmorphic Disorder

Keywords

Pediatric; Body Dysmorphic Disorder; BDD; CBT; Cognitive-Behavioral Therapy

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (3)

• 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

Study Arms (1)

Cognitive-Behavioral Therapy

EXPERIMENTAL

Behavioral: Cognitive-Behavioral Therapy

Interventions

Cognitive-Behavioral Therapy BEHAVIORAL

20 sessions of Cognitive-Behavioral Therapy

Cognitive-Behavioral Therapy

Eligibility Criteria

• Age: 10 Years - 17 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Massachusetts General Hospital: lead

Study Sites (1)

Massachusetts General Hospital

Boston, Massachusetts, 02114, United States

Location

MeSH Terms

Conditions

Body Dysmorphic Disorders

Interventions

Cognitive Behavioral Therapy

Condition Hierarchy (Ancestors)

Somatoform Disorders; Mental Disorders

Intervention Hierarchy (Ancestors)

Behavior Therapy; Psychotherapy; Behavioral Disciplines and Activities

Study Officials

• Sabine Wilhelm, Ph.D.

  Massachusetts General Hospital

  PRINCIPAL INVESTIGATOR

• Jennifer Greenberg, Psy.D.

  Massachusetts General Hospital

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Director, OCD and Related Disorders Program at Massachusetts General Hospital

Study Record Dates

• First Submitted: October 26, 2009
• First Posted: October 27, 2009
• Study Start: June 1, 2009
• Primary Completion: August 1, 2015
• Study Completion: August 1, 2015
• Last Updated: March 16, 2016

Record last verified: 2016-03

Locations

US (1)