Randomized Controlled Trial of the Meru Health Program Versus Waitlist Control for Adults With Depression
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 100
- 试验地点
- 2
- 主要终点
- Depression
研究概览
简要总结
This is a randomized controlled trial (RCT) of the Meru Health Program (MHP) versus a waitlist (WL) control group, which will be offered access to the MHP after the waitlist period (12 weeks) is over, for adults with depression. The Meru Health Program (MHP) is a 12-week mobile mental health intervention delivered via Smartphone app that includes components of several evidence-based treatments (Cognitive Behavioral Therapy, Behavioral Activation Therapy, Mindfulness Meditation) and also several promising therapies (heart rate variability-biofeedback [HRVB], nutritional psychiatry, sleep training) that is overseen by a licensed clinical therapist.
详细描述
Title: Randomized Controlled Trial of the Meru Health Program versus Waitlist Control for Adults with Depression
Study Description: This is a randomized controlled trial (RCT) of the Meru Health Program (MHP) versus a waitlist (WL) control group, which will be offered access to the MHP after the waitlist period (12 weeks) is over, for adults with depression.
Objectives*:
Primary Objective: To compare changes in depressive symptoms and reduction in clinically significant depression at the end of the program and compare between those in the MHP group versus WL group
Secondary Objectives: To compare changes in anxiety, worker productivity, burnout symptoms, resilience, insomnia, quality of life, days spent engaging with the program per week and hours spent in various program activities per week between those in the MHP group versus WL 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)
盲法说明
Data analyst will be blind to study group
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •18 years or older
- •Own a Smartphone
- •Lives in Colorado
排除标准
- •Screen positive for a psychotic disorder, bipolar disorder, alcohol or drug use disorder, or suicidal plans
结局指标
主要结局
Depression
时间窗: 12 weeks
Mean change in Patient Health Questionnaire-9 item depression scale during the program. Scores range from 0 to 27, with higher scores indicative of more depression.
次要结局
- Anxiety(12 weeks)
- Quality of life as measured by the EQ-5D(12 weeks)
- Resilience(12 weeks)
- Worker Productivity and Activity Impairment(12 weeks)
- Insomnia(12 weeks)
- Burnout(12 weeks)
- Patient-reported adverse events(during the 12-week intervention)