Beyond the Clinic: Enhancing Depression Surveillance With a Digital Biomarker
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 320
- 试验地点
- 4
- 主要终点
- Monthly depression relapse
研究概览
简要总结
Researchers hope to see if the data smartphones collect continuously can be used to predict if patient's depression symptoms will return. They will do this by collecting data from patient's smartphones and comparing it to their depression symptoms. If this method is successful, researchers could develop a smartphone application to help healthcare providers better monitor patient's depression and intervene earlier if symptoms return.
详细描述
Study phase 1: The investigators expect that participants will be in this research study for six months. Participants will be asked to download an app on their smartphone. This app will collect data from the phone's sensors. Participants will also be asked to answer some questions about their mood each month.
Study phase 2: This phase of the study is randomized which means that in order to learn about the effect of the Smartphone App, half the people in this study will use it, and the other half will not. If participants decide to enroll into this research study, they will be assigned by chance to one of the following groups:
Group A: Participants will be asked to download a Smartphone App. This App will collect data from the phone's sensors.
Group B: Participants will have usual care. Both Groups: Participants will be asked to complete questionnaires about their mood each month.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 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
- •Adult patients (18 years or older)
- •Treated for depression within Dartmouth Health collaborative care model (CoCM) sites who are discharged from CoCM without depression (PHQ-9 < 10)
- •Have access to and ability to use a smartphone (Android version ≥ 6 or iOS version ≥ 11).
排除标准
- •Identified as high risk due to active suicidality, psychosis, or bipolar disorder - Discharged from CoCM with ongoing depressive symptoms (PhQ-9 > 10
研究组 & 干预措施
Phase 1: Sensing System Calibration (N = 120)
We expect that participants will be in this research study for six months. Participants will be asked to download an app on their smartphone. This app will collect data from the phone's sensors. Participants will also be asked to answer some questions about their mood each month.
干预措施: MoodTriggers Application (Other)
Phase 2: Early warning system (n = 100)
This study is randomized which means that in order to learn about the effect of the Smartphone App, half the people in this study will use it, and the other half will not. If participants decide to enroll into this research study, they may be assigned by chance to download a Smartphone App. This App will collect data from the phone's sensors. Participants will also be asked to complete questionnaires about their mood each month.
干预措施: MoodTriggers Application (Other)
Phase 2: Usual Care (n = 100)
This study is randomized which means that in order to learn about the effect of the Smartphone App, half the people in this study will use it, and the other half will not. If participants decide to enroll into this research study, they may be assigned by chance to have usual care. Participants will be asked to complete questionnaires about their mood each month.
结局指标
主要结局
Monthly depression relapse
时间窗: discharge, 6-months post-discharge
The 9-item Patient Health Questionnaire (PHQ-9), a validated self-reported depression questionnaire, will be used to detect monthly depression recurrence based on past-month MoodTriggers application data. The PHQ-9 scores range from 0-27, with higher scores reflecting higher depression symptom levels. The PHQ-9 will be used to detect monthly recurrence of Major Depressive Disorder (MDD; PHQ-9 scores ≥ 10) during Phase 1 in all 120 participants. For the randomized clinical trial in Phase 2, we will capture the PHQ-9 monthly in both arms (MoodTriggers app vs. no app) for 6-months following discharge.
次要结局
- Perceived benefits and barriers of depression monitoring using passive sensing data collected from mobile phones(0-6 months post-discharge)
研究者
Nicholas C. Jacobson
Principal Investigator
Dartmouth-Hitchcock Medical Center