Cognitive-Behavioral Therapy for Pediatric Body Dysmorphic Disorder
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 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)|
- 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 ]
- 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 ]
|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)|
|Experimental: Cognitive-Behavioral Therapy||
Behavioral: Cognitive-Behavioral Therapy
20 sessions of Cognitive-Behavioral Therapy
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.
|United States, Massachusetts|
|Massachusetts General Hospital|
|Boston, Massachusetts, United States, 02114|
|Principal Investigator:||Sabine Wilhelm, Ph.D.||Massachusetts General Hospital|
|Study Director:||Jennifer Greenberg, Psy.D.||Massachusetts General Hospital|