Smartphone Cognitive Behavioral Therapy for Obsessive-Compulsive Disorder: A Randomized, Waitlist-control Trial
试验速览
- 阶段
- 不适用
- 状态
- 撤回
- 试验地点
- 2
- 主要终点
- Difference in OCD severity (Y-BOCS) 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 obsessive compulsive disorder (OCD). The investigators hypothesize that participants receiving app-CBT will have greater improvement in Y-BOCS scores than those in the waitlist condition at treatment endpoint (week 12).
详细描述
The primary aims of this study are to test the efficacy of a Smartphone-based CBT treatment for adults with OCD recruited nationally. Eligible subjects (N=58) will be randomly assigned to 12 weeks of Smartphone-delivered CBT for OCD either immediately, or after a 12-week long waiting period (50-50 chance). The investigators hypothesize that Smartphone-delivered CBT for OCD will be feasible and acceptable to individuals with OCD, and that it will lead to greater reductions in OCD symptom severity compared to the passage of time (waitlist control).
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
- 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
- •current diagnosis of primary DSM-5 OCD, based on MINI
- •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 CBT for OCD
- •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 C-SSRS
- •Current severe comorbid major depression, as indicated by clinical judgment and/or a QIDS-SR total score ≥ 21
- •Concurrent psychological treatment
- •Does not own a supported mobile 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 OCD severity (Y-BOCS) at the end of treatment/waitlist period.
时间窗: Endpoint (week 12)
The Yale-Brown Obsessive Compulsive Scale (Y-BOCS) is the gold-standard, semi-structured clinician-administered assessment of OCD severity. It contains 10 items ranging from 0 to 4, which are summed to generate a total score (range = 0-40). Higher scores indicate more severe OCD symptoms. The Y-BOCS will be used to assess change in OCD symptoms from baseline to endpoint.
次要结局
- Difference in functional impairment at the end of treatment/waitlist period(Endpoint (week 12))
- Difference in depression at the end of treatment/waitlist period(Endpoint (week 12))
- Difference in quality of life at the end of treatment/waitlist period(Endpoint (week 12))
研究者
Sabine Wilhelm, PhD
Chief of Psychology
Massachusetts General Hospital