Smartphone Cognitive Behavioral Therapy for Major Depressive Disorder: A Randomized, Waitlist-control Trial
试验速览
- 阶段
- 不适用
- 状态
- 撤回
- 入组人数
- 112
- 试验地点
- 2
- 主要终点
- Difference in MDD severity (SIGH-D) 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 major depressive disorder (MDD). The investigators hypothesize that participants receiving app-CBT will have greater improvement in SIGH-D scores than those in the waitlist condition at treatment endpoint (week 8).
详细描述
The primary aims of this study are to test the efficacy of a Smartphone-based CBT treatment for adults with MDD recruited nationally. Eligible subjects (N=112) will be randomly assigned to 8 weeks of Smartphone-delivered CBT for MDD either immediately, or after a 8-week long waiting period (50-50 chance). The investigators hypothesize that Smartphone-delivered CBT for MDD will be feasible and acceptable to individuals with MDD, and that it will lead to greater reductions in MDD 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 MDD, 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 depression
- •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
- •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 MDD severity (SIGH-D) at the end of treatment/waitlist period.
时间窗: Endpoint (week 8)
The Structured Interview Guide for the Hamilton Depression Rating Scale (SIGH-D) is a clinician-administered interview that assesses depressive symptom severity in the past seven days. It contains 16 items ranging from 0-3, which are summed to generate a total score of depressive symptom severity (range=0-27). \*\*\*\* EDIT
次要结局
- Difference in quality of life at the end of treatment/waitlist period: Q-LES-Q-SF(Endpoint (week 8))
- Difference in functional impairment at the end of treatment/waitlist period(Endpoint (week 8))
研究者
Sabine Wilhelm, PhD
Chief of Phycology
Massachusetts General Hospital