Back to resultsCognitive-Behavioral Therapy for Pediatric Body Dysmorphic Disorder
Primary Purpose
Body Dysmorphic Disorder
Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Cognitive-Behavioral Therapy
Sponsored by
About this trial
This is an interventional treatment trial for Body Dysmorphic Disorder focused on measuring Pediatric, Body Dysmorphic Disorder, BDD, CBT, Cognitive-Behavioral Therapy
Eligibility 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
Sites / Locations
- Massachusetts General Hospital
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Cognitive-Behavioral Therapy
Arm Description
Outcomes
Primary Outcome Measures
Yale-Brown Obsessive Compulsive Scale Modified for BDD (BDD-YBOCS)-Pediatric Version
Secondary Outcome Measures
Brown Assessment of Beliefs Scale (BABS)-Pediatric Version
Clinical Global Impression Scale (CGI)
Children's Depression Inventory (CDI)
Full Information
NCT ID
NCT01002326
First Posted
October 26, 2009
Last Updated
March 15, 2016
Sponsor
Massachusetts General Hospital
1. Study Identification
Unique Protocol Identification Number
NCT01002326
Brief Title
Cognitive-Behavioral Therapy for Pediatric Body Dysmorphic Disorder
Official Title
An Open Trial of Cognitive-Behavioral Therapy (CBT) for Pediatric Body Dysmorphic Disorder (BDD)
Study Type
Interventional
2. Study Status
Record Verification Date
March 2016
Overall Recruitment Status
Completed
Study Start Date
June 2009 (undefined)
Primary Completion Date
August 2015 (Actual)
Study Completion Date
August 2015 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Massachusetts General Hospital
4. Oversight
Data Monitoring Committee
No
5. Study Description
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.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Body Dysmorphic Disorder
Keywords
Pediatric, Body Dysmorphic Disorder, BDD, CBT, Cognitive-Behavioral Therapy
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
13 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Cognitive-Behavioral Therapy
Arm Type
Experimental
Intervention Type
Behavioral
Intervention Name(s)
Cognitive-Behavioral Therapy
Intervention Description
20 sessions of Cognitive-Behavioral Therapy
Primary Outcome Measure Information:
Title
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
Secondary Outcome Measure Information:
Title
Brown Assessment of Beliefs Scale (BABS)-Pediatric Version
Time Frame
Baseline, Monthly, Post-Treatment, 3-Month Follow-Up, 6-Month Follow-Up
Title
Clinical Global Impression Scale (CGI)
Time Frame
Baseline, Monthly, Post-Treatment, 3-Month Follow-Up, 6-Month Follow-Up
Title
Children's Depression Inventory (CDI)
Time Frame
Baseline, Weekly, Post-Treatment, 3-Month Follow-Up, 6-Month Follow-Up
10. Eligibility
Sex
All
Minimum Age & Unit of Time
10 Years
Maximum Age & Unit of Time
17 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Sabine Wilhelm, Ph.D.
Organizational Affiliation
Massachusetts General Hospital
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Jennifer Greenberg, Psy.D.
Organizational Affiliation
Massachusetts General Hospital
Official's Role
Study Director
Facility Information:
Facility Name
Massachusetts General Hospital
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02114
Country
United States
12. IPD Sharing Statement
Learn more about this trial
Cognitive-Behavioral Therapy for Pediatric Body Dysmorphic Disorder
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