Cognitive-Behavioral Therapy for Pediatric Body Dysmorphic Disorder

Body Dysmorphic Disorder Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01002326
• Other study ID #: 2008P002270
• Status: Completed
• Phase: N/A
• First received: October 26, 2009
• Last updated: March 15, 2016
• Start date: June 2009
• Est. completion date: August 2015

Study information

• Verified date: March 2016
• Source: Massachusetts General Hospital
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 13
• Est. completion date: August 2015
• Est. primary completion date: August 2015
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 10 Years to 17 Years

Eligibility

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 Design

Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Body Dysmorphic Disorder
• Body Dysmorphic Disorders

Intervention

Behavioral:
• Cognitive-Behavioral Therapy
20 sessions of Cognitive-Behavioral Therapy

Locations

Country	Name	City	State
United States	Massachusetts General Hospital	Boston	Massachusetts

Sponsors (1)

Lead Sponsor	Collaborator
Massachusetts General Hospital

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Yale-Brown Obsessive Compulsive Scale Modified for BDD (BDD-YBOCS)-Pediatric Version		Baseline, Monthly, Post-Treatment, 3-Month Follow-Up, 6-Month Follow-Up	No
Secondary	Brown Assessment of Beliefs Scale (BABS)-Pediatric Version		Baseline, Monthly, Post-Treatment, 3-Month Follow-Up, 6-Month Follow-Up	No
Secondary	Clinical Global Impression Scale (CGI)		Baseline, Monthly, Post-Treatment, 3-Month Follow-Up, 6-Month Follow-Up	No
Secondary	Children's Depression Inventory (CDI)		Baseline, Weekly, Post-Treatment, 3-Month Follow-Up, 6-Month Follow-Up	Yes