Skip to main content
OpenTrials
Completed

NCT Number: NCT01002326

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.

Completed

Looking for future studies?

Notify Me

Key information

Age range

10 year–17 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Massachusetts General Hospital

Boston, Massachusetts, 02114, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Cognitive-Behavioral Therapy

Behavioral

20 sessions of Cognitive-Behavioral Therapy

Primary outcomes

  1. 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 outcomes

  1. Brown Assessment of Beliefs Scale (BABS)-Pediatric Version

    Time frame: Baseline, Monthly, Post-Treatment, 3-Month Follow-Up, 6-Month Follow-Up

  2. Clinical Global Impression Scale (CGI)

    Time frame: Baseline, Monthly, Post-Treatment, 3-Month Follow-Up, 6-Month Follow-Up

  3. Children's Depression Inventory (CDI)

    Time frame: Baseline, Weekly, Post-Treatment, 3-Month Follow-Up, 6-Month Follow-Up

Sponsors and collaborators

Lead sponsor

Massachusetts General Hospital

Other

Registry information

Official study title

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

Important dates

Study start
2009
Primary completion
2015
Study completion
2015
First posted
Oct 27, 2009
Registry last updated
Mar 16, 2016

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.