Digital Health Interventions for Obsessive Compulsive Disorder: A Randomized Controlled Trial
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 120
- 试验地点
- 2
- 主要终点
- Difference in OCD Symptom Severity at the End of Week 12
研究概览
简要总结
The investigators are testing two digital health interventions for obsessive compulsive disorder (OCD). The investigators hope that these digital health programs will increase access to treatment for OCD.
详细描述
The primary aims of this study are to test the feasibility, acceptability, and efficacy of two digital health interventions for adults with OCD recruited nationally. Eligible subjects (N=120) will be randomly assigned (50/50 chance) to 12 weeks of app-based CBT on their personal Smartphone or 12 weeks of web-based health and well-being education in addition to completing clinical assessments and questionnaires from home. All participants will have access to a coach to help guide them through their assigned program. Total participation time for the study is approximately 6 months, and all study appointments (5 total) occur over secure phone or video conference call.
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 obsessive compulsive disorder (OCD), based on the Diagnostic and Statistical Manual of Mental Disorders, Fifth Edition (DSM-5), Mini International Neuropsychiatric Interview (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 cognitive behavioral therapy (CBT) for OCD
- •Past use of a CBT for OCD app
- •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 version (QIDS-SR), total score ≥ 21
- •Current post-traumatic stress disorder (PTSD)
- •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 Symptom Severity at the End of Week 12
时间窗: Baseline (week 0), mid-treatment (week 6), end-of-treatment (week 12)
Symptom severity for OCD was measured with the Yale-Brown Obsessive Compulsive Scale (Y-BOCS), 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 to 40). Higher scores indicate more severe OCD symptoms.
次要结局
- Difference in Depression at the End of Week 12(Baseline (week 0), mid-treatment (week 6), end-of-treatment (week 12))
- Difference in Functional Impairment at the End of Week 12(Week 0, Week 6, and Week 12)
- Difference in Quality of Life at the End of Week 12(Week 0, Week 6, and Week 12)
研究者
Sabine Wilhelm, PhD
Chief of Psychology
Massachusetts General Hospital