Mental Health-App for Improving Depressive Symptoms
试验速览
- 阶段
- 不适用
- 状态
- 暂停
- 入组人数
- 300
- 试验地点
- 2
- 主要终点
- Patient Health Questionnaire 9 (PHQ-9)
研究概览
简要总结
The goal of this clinical trial is to learn if the Syrenity mental health app reduces depressive symptoms when compared to a control condition. Secondarily, the trial will provide data on the usability and acceptability of the Syrenity app. The main questions it aims to answer are:
Does Syrenity reduce self-reported depressive symptoms compared to a waiting list control? How usable is the Syrenity app?
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
- •PHQ-9 >= 10
- •Use an iPhone or Android
- •Residing in the United States
排除标准
- •PHQ-9 item 9 >= 2
研究组 & 干预措施
Syrenity App
The Syrenity App is a mental health app that has been designed to help improve mental health and well-being. The content on the app was created using cognitive-behavioral therapy principles. It uses both active and passive interventions. Active interventions are interventions where the user engages with the app in a back and forth dialogue (e.g., a conversation about restructuring unhelpful thoughts). Passive interventions meanwhile consist of text or videos that the user can read or watch and do not require dialogue with the app.
干预措施: Syrenity App (Other)
Waiting list control
Those assigned to the waiting list control condition will complete weekly surveys as those assigned to the intervention group but will not have access to the Syrenity platform until after the the 6-week trial period.
结局指标
主要结局
Patient Health Questionnaire 9 (PHQ-9)
时间窗: 6 weeks
Depression symptoms will be assessed with the PHQ-9. The PHQ-9 is a 9-item self-report measure that assesses the frequency of symptoms of major depressive disorder as outlined by the Diagnostic and Statistical Manual of Mental Disorders (DSM-5). Response options range from 0 ("not at all") to 3 (nearly every day). Total scores on the PHQ-9 range from 0-27 with greater scores indicating greater frequency of depressive symptoms. A score greater than or equal to 10 on the PHQ-9 has been identified as a positive screen for major depression (Kroenke \& Spitzer, 2002). PHQ-9 will be assessed at baseline, and each week of the intervention.
次要结局
- Systems Usability Scale (SUS)(6 weeks)
- Generalized Anxiety Disorder Scale-7 (GAD-7)(6 weeks)
研究者
Lorenzo Lorenzo-Luaces
Associate Professor
Indiana University