A Feasibility Randomized Controlled Trial Evaluating the Effectiveness of a Digital Mental Health Intervention for Moderate/Severe Depression and Anxiety
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 86
- 主要终点
- Recruitment
研究概览
简要总结
A digital mental health intervention (BetterHelp, Mountain View, CA) provides users with access to online therapy care for treatment of depression and anxiety. This feasibility randomized controlled trial compares clinical outcomes of an intervention group, who will enroll in the digital mental health platform, to a control group.
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
- •Age 18 years or older
- •Has moderate or severe baseline anxiety or depression, as defined by GAD-7 ≥ 10 or PHQ-9 ≥ 10, respectively
- •Based in the US
- •Fluent in the English language
- •Has an email account to receive and complete online surveys
- •Has access to a smartphone, tablet or computer
- •Able to understand and provide informed consent
排除标准
- •Pregnant or plan on becoming pregnant in the next 6 months
- •Has no or mild baseline anxiety or depression, as defined by GAD-7 < 10 and PHQ-9 < 10, respectively
研究组 & 干预措施
Intervention
Participants enrolled in a digital mental health platform, which provided access to licensed therapists, group therapy sessions, and a library of educational articles.
干预措施: BetterHelp (Other)
Control
Participants were not enrolled in a digital mental health platform, but continued their standard routine or care as needed.
结局指标
主要结局
Recruitment
时间窗: 90 days
Recruitment rates for study participation
Adherence
时间窗: 90 days
Adherence rates to study procedures
次要结局
- GAD-7(Baseline, 45 days, 90 days)
- PHQ-9(Baseline, 45 days, 90 days)