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Cognitive-Behavioral Therapy for Pediatric Body Dysmorphic Disorder

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
Sabine Wilhelm, Massachusetts General Hospital
ClinicalTrials.gov Identifier:
NCT01002326
First received: October 26, 2009
Last updated: April 9, 2014
Last verified: April 2014
  Purpose

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.


Condition Intervention
Body Dysmorphic Disorder
Behavioral: Cognitive-Behavioral Therapy

Study Type: Interventional
Study Design: Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: An Open Trial of Cognitive-Behavioral Therapy (CBT) for Pediatric Body Dysmorphic Disorder (BDD)

Further study details as provided by Massachusetts General Hospital:

Primary Outcome Measures:
  • Yale-Brown Obsessive Compulsive Scale Modified for BDD (BDD-YBOCS)-Pediatric Version [ Time Frame: Baseline, Monthly, Post-Treatment, 3-Month Follow-Up, 6-Month Follow-Up ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Brown Assessment of Beliefs Scale (BABS)-Pediatric Version [ Time Frame: Baseline, Monthly, Post-Treatment, 3-Month Follow-Up, 6-Month Follow-Up ] [ Designated as safety issue: No ]
  • Clinical Global Impression Scale (CGI) [ Time Frame: Baseline, Monthly, Post-Treatment, 3-Month Follow-Up, 6-Month Follow-Up ] [ Designated as safety issue: No ]
  • Children's Depression Inventory (CDI) [ Time Frame: Baseline, Weekly, Post-Treatment, 3-Month Follow-Up, 6-Month Follow-Up ] [ Designated as safety issue: Yes ]

Estimated Enrollment: 12
Study Start Date: June 2009
Estimated Study Completion Date: December 2014
Estimated Primary Completion Date: December 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Cognitive-Behavioral Therapy Behavioral: Cognitive-Behavioral Therapy
20 sessions of 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.

  Eligibility

Ages Eligible for Study:   10 Years to 17 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01002326

Locations
United States, Massachusetts
Massachusetts General Hospital
Boston, Massachusetts, United States, 02114
Sponsors and Collaborators
Massachusetts General Hospital
Investigators
Principal Investigator: Sabine Wilhelm, Ph.D. Massachusetts General Hospital
Study Director: Jennifer Greenberg, Psy.D. Massachusetts General Hospital
  More Information

No publications provided

Responsible Party: Sabine Wilhelm, Director, OCD and Related Disorders Program at Massachusetts General Hospital, Massachusetts General Hospital
ClinicalTrials.gov Identifier: NCT01002326     History of Changes
Other Study ID Numbers: 2008P002270
Study First Received: October 26, 2009
Last Updated: April 9, 2014
Health Authority: United States: Institutional Review Board

Keywords provided by Massachusetts General Hospital:
Pediatric
Body Dysmorphic Disorder
BDD
CBT
Cognitive-Behavioral Therapy

Additional relevant MeSH terms:
Body Dysmorphic Disorders
Disease
Mental Disorders
Pathologic Processes
Somatoform Disorders

ClinicalTrials.gov processed this record on November 25, 2014