Smartphone Cognitive Behavioral Therapy for Body Dysmorphic Disorder: A Randomized, Waitlist-control Trial
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 80
- 试验地点
- 2
- 主要终点
- Difference in BDD Severity (BDD-YBOCS) at the End of Treatment/Waitlist Period.
研究概览
简要总结
The investigators are testing the efficacy of Smartphone-delivered cognitive behavioral therapy (CBT) treatment for body dysmorphic disorder (BDD). The investigators hypothesize that participants receiving app-CBT will have greater improvement in body dysmorphic disorder symptom severity than those in the waitlist condition at treatment endpoint (week 12).
详细描述
The primary aim of this study is to test the efficacy of a Smartphone-based cognitive behavioral therapy (CBT) treatment for adults with body dysmorphic disorder (BDD) recruited nationally. In a prior study (Clinical Trials Identifier # NCT03221738), the investigators developed and pilot-tested the feasibility, acceptability, and preliminary efficacy of a CBT for BDD app in an open pilot trial. The investigators are now further testing these outcomes in a randomized controlled trial. Eligible subjects (N= 64) will be randomly assigned to 12-weeks of Smartphone-delivered CBT for BDD either immediately, or after a 12-week long waiting period (50/50 chance).
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Single (Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •at least 18 years of age
- •current diagnosis of primary body dysmorphic disorder (BDD), based on a clinical structured diagnostic interview
- •currently living in the United States
排除标准
- •Psychotropic medication changes within 2 months prior to enrollment (Participants taking psychotropic medication must have been on a stable dose for at least 2 months prior to enrollment and not change medication during study period)
- •Past participation in 4+ sessions of cognitive behavioral therapy (CBT) for body dysmorphic disorder (BDD)
- •Current severe substance use disorder
- •Lifetime bipolar disorder or psychosis
- •Acute, active suicidal ideation as indicated by clinical judgment and/or a score >2 on the suicidal ideation subscale of the Columbia-Suicide Severity Rating Scale (C-SSRS).
- •Current severe comorbid major depression, as indicated by clinical judgment and/or a Quick Inventory of Depressive Symptomatology- Self Report (QIDS-SR) total score ≥ 21
- •Concurrent psychological treatment
- •Does not own a supported Smartphone with a data plan
- •Lack of technology literacy that would interfere with ability to engage with smartphone treatment
结局指标
主要结局
Difference in BDD Severity (BDD-YBOCS) at the End of Treatment/Waitlist Period.
时间窗: Week 0, Week 6, and Week 12
The BDD Yale-Brown Obsessive Compulsive Scale (BDD-YBOCS) is the gold-standard, semi-structured clinician-administered assessment of BDD severity. It contains 12 items ranging from 0 to 4, which are summed to generate a total score (range = 0 to 48). Higher scores indicate more severe BDD symptoms. The BDD-YBOCS
次要结局
- Difference in Delusionality at the End of Treatment/Waitlist Period(Week 0, Week 6, and Week 12)
- Difference in Depression at the End of Treatment/Waitlist Period(Week 0, Week 6, and Week 12)
- Difference in Functional Impairment at the End of Treatment/Waitlist Period(Week 0, Week 6, and Week 12)
- Difference in Quality of Life at the End of Treatment/Waitlist Period(Week 0, Week 6, and Week 12)
研究者
Sabine Wilhelm, PhD
Chief of Psychology
Massachusetts General Hospital