Development of a Cognitive Behavioral Mobile App for Body Dysmorphic Disorder, and Tests of Feasibility, Acceptability, and Preliminary Efficacy
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 10
- 试验地点
- 2
- 主要终点
- Treatment Completion Rates
研究概览
简要总结
The investigators are developing and testing a Smartphone-based cognitive behavioral therapy (CBT) "app" for body dysmorphic disorder (BDD). The investigators hypothesize that app-based CBT for BDD will be feasible and acceptable to individuals with BDD, and will improve body image concerns and related outcomes.
详细描述
The primary aims of this study are to develop and test the feasibility, acceptability, and preliminary efficacy of a Smartphone-based CBT treatment for adults with BDD. This project aims to solve two healthcare problems: poor access to empirically-supportive treatment for BDD, and challenges of generalizing CBT skills outside therapy sessions. Inadequate treatment access is due to limited professionals offering this specialized treatment, economic barriers, and shame preventing sufferers from seeking in-person care. Mobile app-based CBT would solve this access gap by addressing each of these barriers. Among those who obtain CBT, practicing skills outside of therapy is critical for treatment effectiveness, as BDD symptoms occur around-the-clock and can be most impairing at home. However, BDD patients struggle to use skills without therapists' in-person support. App-based CBT that provides on-hand skills coaching addresses this treatment generalization challenge.
This study involves developing the app-based CBT for BDD treatment, and then investigating the initial feasibility, acceptability, and preliminary efficacy of the app-based treatment in an open pilot trial (N = 10), consisting of 12-weeks of active treatment plus a 6-month follow up period.
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
- 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
- •Outpatients
- •Meets current diagnosis of primary DSM-5 BDD
- •Has score on BDD-YBOCS of ≥ 20
- •Currently living in the United States
排除标准
- •Psychotropic medication changes within 2 months prior to enrollment
- •Participants taking psychotropic medication have to have been on a stable dose for at least 2 months prior to enrollment and not change medication during study period
- •Participated in CBT for BDD ever during lifetime
- •Current substance dependence
- •Lifetime bipolar disorder or psychosis
- •Acute, active suicidal ideation
- •Current severe comorbid major depression, defined by a PHQ-9 total score ≥ 20
- •Personality disorder that could jeopardize treatment participation (e.g., borderline personality disorder with self-harm)
- •Concurrent psychological treatment
- •Do not own a supported mobile Smart phone with a data plan (currently iPhone 5S or more recent, running iOS 9 or newer)
- •Intellectual disability or other cognitive impairment that would interfere with ability to engage in CBT
研究组 & 干预措施
App-Based Cognitive Behavioral Therapy
12-week Smartphone-delivered CBT for BDD.
干预措施: App-Based Cognitive Behavioral Therapy (Behavioral)
结局指标
主要结局
Treatment Completion Rates
时间窗: Post treatment assessment (12 weeks)
Number of subjects who completed the app-based treatment to assess feasibility and acceptability
Client Satisfaction Questionnaire (CSQ). This Measure Will be Used to Assess Change Over the Course of Treatment Twice Throughout the Study (Over Approximately 10 Months Total).
时间窗: Post-treatment assessment (week 12)
The Client Satisfaction Questionnaire (CSQ) is a 25-item self-report questionnaire which assesses the satisfaction with clinical services received. Total scores range from 8 to 32, with the higher number indicating greater satisfaction.
次要结局
- Yale Brown Obsessive Compulsive Scale Modified for BDD (BDD-YBOCS). This Measure Will be Used to Assess Change Over the Course of Treatment at Five Time Points Throughout the Study (Over Approximately 10 Months Total).(Post-treatment assessment (week 12))
研究者
Sabine Wilhelm, PhD
Sabine Wilhelm, Ph.D., Chief of Psychology
Massachusetts General Hospital