An Open Trial of Cognitive-Behavioral Therapy (CBT) for Pediatric Body Dysmorphic Disorder (BDD)
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 13
- 试验地点
- 2
- 主要终点
- Yale-Brown Obsessive Compulsive Scale Modified for BDD (BDD-YBOCS)-Pediatric Version
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 10 Years 至 17 Years（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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
排除标准
- •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
结局指标
主要结局
Yale-Brown Obsessive Compulsive Scale Modified for BDD (BDD-YBOCS)-Pediatric Version
时间窗: Baseline, Monthly, Post-Treatment, 3-Month Follow-Up, 6-Month Follow-Up
次要结局
- Children's Depression Inventory (CDI)(Baseline, Weekly, Post-Treatment, 3-Month Follow-Up, 6-Month Follow-Up)
- Brown Assessment of Beliefs Scale (BABS)-Pediatric Version(Baseline, Monthly, Post-Treatment, 3-Month Follow-Up, 6-Month Follow-Up)
- Clinical Global Impression Scale (CGI)(Baseline, Monthly, Post-Treatment, 3-Month Follow-Up, 6-Month Follow-Up)
研究者
Sabine Wilhelm
Director, OCD and Related Disorders Program at Massachusetts General Hospital
Massachusetts General Hospital