Technology Enabled Services to Enhance Depression Care
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 130
- 试验地点
- 2
- 主要终点
- Patient Health Questionaire-9 (PHQ-9)
研究概览
简要总结
This study will compare two digital mental health interventions (DMHIs). One DMHI will use an app called Vira (which is a product developed and managed by Ksana Health), along with low intensity coaching provided via phone and both SMS text and in-app messaging. The other DMHI will provide a broad range of information on how to manage symptoms of depression, anxiety, and stress. The DMHI will be evaluated with patients receiving care from Rush University Medical Center's primary care and family medicine clinics, which serve racially, ethnically, and economically diverse communities; evaluations may also be extended beyond Rush patients.
详细描述
Depression and anxiety are common and impose a tremendous societal burden in terms of cost, morbidity, quality of life, and mortality. Yet, few people are able to obtain adequate or appropriate treatment.
This trial will compare the ability of two digital mental health interventions (DMHIs) to reduce depression and anxiety. One DMHI, called Mood Education App, provides information on depression and a broad range of strategies that are effective in improving symptoms. The other app, called VIRA, uses smartphone sensors to identify a few behavioral markers, including mobility patterns, physical activity, and sleep. The results of these sensed behavioral markers are used to give the participant behavior change recommendations through the Vira app that are expected to result in symptom improvement. The DMHI will include low intensity coaching, which includes one or more brief phone calls and communication via SMS text and in-app messaging. Both treatments are 8-weeks long.
The trial will be conducted within Rush University Medical Center's primary care and family medicine clinics, although recruitment be expanded beyond these clinics.
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
- 13 Years 至 —（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •US Citizen/ Resident
- •13 years or older
- •English Speaking
- •Owns an Android or iPhone smartphone with an up-to-date operating system
- •Has used a smartphone in the last 7 days
- •PHQ-8 greater than or equal to 10 and/or GAD-7 greater than or equal to 10
排除标准
- •Children under the age of 13
- •Severe suicidality (as defined by presence of a plan + intent to act on that plan)
研究组 & 干预措施
Sensor-enabled digital mental health intervention (DMHI)
Patients randomized to sensor-enabled DMHI condition will use Ksana Health's "Vira" mobile therapy platform with support from a study coach
干预措施: VIRA App (Other)
Experimental: Control Treatment (CT)
Participants randomized to the CT condition will use a Mood Education App designed by researchers at the University of Virginia to deliver psychoeducational content to help people self-manage symptoms of depression, anxiety, and stress.
干预措施: Mood Education App (Other)
结局指标
主要结局
Patient Health Questionaire-9 (PHQ-9)
时间窗: 12 weeks
The PHQ-9 measures depression symptom severity on a scale of 0-27, with higher scores indicating greater symptom severity.
Generalized Anxiety Disorder-7 (GAD-7)
时间窗: 12 weeks
The GAD-7 measures anxiety symptom severity on a scale of 0-21, with higher scores indicating greater symptoms severity
次要结局
未报告次要终点
研究者
David Mohr
Principal Investigator
Northwestern University