Providing Mental Health Precision Treatment
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 2,118
- 试验地点
- 1
- 主要终点
- Change in Depression as Measured by the Patient Health Questionnaire 9 (PHQ-9)
研究概览
简要总结
This research study is being conducted to understand if patients benefit from mobile health interventions while waiting for in-clinic mental health treatments, and to understand which patients receive the most benefit.
详细描述
Initially, results-reporting was planned for 12-month data. However, following 6-week data collection, the participants received other care, so the decision was made to report on the 6-week data.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Health Services Research
- 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
- •Must have a scheduled mental health intake appointment at Michigan Medicine Outpatient Psychiatry or University Health Service at the University of Michigan
- •Must have daily access to a smartphone version that is compatible with study activity trackers.
- •Understands English to enable consent and use of the MyDataHelps app and app-based interventions
- •Provide complete, updated contact information upon enrollment to the study
- •Agree to be contacted by study staff during the study
- •Willingness to keep study setup (devices, apps, settings) in required configuration for the duration of the study, and following instructions by study staff if required to update or re-achieve required configuration if required configuration has been lost (e.g., change of phone, app deletion)
排除标准
- •Self-reported or medical record indication of a current eating disorder
- •Scheduled outpatient mental health appointment is a pediatric appointment (even if age 18+)
- •Wrist too large or too small to wear an Apple Watch or Fitbit comfortably (Note: bands that are shorter or longer than the standard will be made available to minimize this exclusion)
研究组 & 干预措施
Enhanced Feedback + Standard Feedback
Participants will receive enhanced feedback from the MyDataHelps study app in addition to standard feedback from the activity tracker.
干预措施: Enhanced Feedback + Standard Feedback (Behavioral)
Headspace app + Standard Feedback
Participants will receive an app-based intervention in addition to standard feedback from the activity tracker.
干预措施: Headspace app + Standard Feedback (Device)
Headspace app + Enhanced Feedback + Standard Feedback
Participants will receive an app-based intervention, enhanced feedback from the MyDataHelps study app, and standard feedback activity tracker.
干预措施: Headspace app + Enhanced Feedback + Standard Feedback (Device)
SilverCloud app + Standard Feedback
Participants will receive an app-based intervention in addition to standard feedback from the activity tracker.
干预措施: SilverCloud + Standard Feedback (Device)
SilverCloud app +Enhanced Feedback +Standard Feedback
Participants will receive an app-based intervention, enhanced feedback from the MyDataHelps study app, and standard feedback from the activity tracker.
干预措施: SilverCloud app +Enhanced Feedback +Standard Feedback (Device)
结局指标
主要结局
Change in Depression as Measured by the Patient Health Questionnaire 9 (PHQ-9)
时间窗: Up to 6 weeks
The PHQ-9 was a multipurpose instrument for screening, diagnosing, monitoring and measuring the severity of depression. The PHQ-9 incorporated self-report questions on 9 specific depression symptoms that align with the DSM-IV depression diagnostic criteria. PHQ-9 scores ranged from 0-27, with 0 indicating no depression and 27 indicating severe depression.
次要结局
- Mood as Measured by the Mental Health App Assessment(Daily up to 6 weeks)
- Change in Suicide Risk as Measured by the Positive and Negative Suicide Ideation Inventory - Positive Ideation (PANSI-PI)(Up to 6 weeks)
- Change in Suicide Risk as Measured by the Positive and Negative Suicide Ideation Inventory - Negative Suicide Ideation (PANSI-NSI)(Up to 6 weeks)
- Change in Anxiety as Measured Using the Generalized Anxiety Disorder 7-Item (GAD-7) Scale(Up to 6 weeks)
- Substance Use as Measured by the Alcohol, Smoking, and Substance Involvement Screening Test (ASSIST)(Up to 6 weeks)
研究者
Amy S.B. Bohnert
Professor
University of Michigan