Evaluation of Meru Health Ascend Mobile Intervention for Depression in Middle Aged and Older Adults
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 70
- 试验地点
- 2
- 主要终点
- change in depressive symptoms
研究概览
简要总结
Using technology to deliver depression interventions is one way could alleviate the public health burden of depression. The study is testing a mobile app intervention program for depression that uses cognitive behavioral skills and mindfulness. This study seeks to obtain feedback on the intervention and refine the intervention and then test the intervention in a larger study. The mobile app intervention called the Meru Health Ascend program consists of the app and therapist support via messaging within the app.
详细描述
The Meru Health Ascend program is a guided self-management program that uses a mobile application to deliver content of the intervention. A licensed therapist (Meru Health employed) provides support to participants as needed and reviews practice logs within the app.The 8-week program teaches cognitive behavioral techniques and mindfulness skills with the aim of improving the user's mental health. The platform provides informational videos, skills practices, group discussion, and messaging with the therapist. The Meru Health program enrolls participants in treatment groups that work through the program at the same time and can provide support to on another on the discussion board within the app.
We are conducting two studies in middle aged and older adults with elevated depressive symptoms to evaluate the Meru Health Ascend program. In the first study (study 1), we will examine the feasibility of the intervention in individuals aged 40 years or older with elevated depression symptoms using an iterative case series. Specifically, we will examine the usability of app and materials, dropout and reasons for dropout, and user perceptions of the program.
We will then conduct a proof-of-concept study (study 2) using a nonrandomized pre-post design to examine whether individuals achieve clinically significant reductions in depressive symptoms.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 40 Years 至 120 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Owns a smart phone, resides in California, PHQ-9 score greater than or equal to 10, stable dose of medication (if taking psychotropic), able to read and understand English.
排除标准
- •Psychotic disorder, possible cognitive impairment, evidence of problematic drinking behavior, active suicide ideation with a plan, active psychological treatment, bipolar disorder (study 2 only)
结局指标
主要结局
change in depressive symptoms
时间窗: Change from baseline to 8 weeks/posttreatment for study 1; change from baseline to 12 weeks for study 2
The Patient Health Questionnaire 9-item (PHQ-9) is a measure that assesses 9 depressive symptoms with scores ranging from 0 to 27. Higher scores indicate more severe depressive symptomatology.
次要结局
- change in anxiety symptoms(Change from baseline to 8 weeks/posttreatment for study 1; change from baseline to 12 weeks for study 2)
研究者
Christine Gould
Principal Investigator
Palo Alto Veterans Institute for Research