COMPASS: Comprehensive Mobile Precision Approach for Scalable Solutions in Mental Health Treatment
试验速览
- 阶段
- 不适用
- 状态
- Enrolling By Invitation
- 入组人数
- 4,400
- 试验地点
- 1
- 主要终点
- 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.
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
- •Seeking mental health services from Michigan Medicine, University Health Services, or collaborative clinics and services.
- •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
排除标准
- •Self-reported or medical record indication of a current eating disorder
- •Unable to provide informed consent (e.g., cognitive or guardianship restrictions)
- •Scheduled outpatient mental health appointment is a pediatric appointment (even if age 18+)
研究组 & 干预措施
Mindfulness with tailored messages
Participants will receive an app-based intervention, tailored messages from the MyDataHelps study app, and activity tracker.
干预措施: Mindfulness + Tailored Messages (Behavioral)
Mindfulness without tailored messages
Participants will receive an app-based intervention and standard feedback from activity tracker.
干预措施: Mindfulness without Tailored Messages (Behavioral)
Cognitive Behavioral Therapy (CBT) with tailored messages
Participants will receive an app-based intervention, tailored messages from the MyDataHelps study app, and activity tracker.
干预措施: Cognitive Behavioral Therapy (CBT) + Tailored Messages (Behavioral)
Cognitive Behavioral Therapy (CBT) without tailored messages
Participants will receive an app-based intervention and standard feedback from activity tracker.
干预措施: Cognitive Behavioral Therapy (CBT) without Tailored Messages (Behavioral)
结局指标
主要结局
Depression as measured by the Patient Health Questionnaire 9(PHQ-9)
时间窗: From enrollment to the 6-week assessment.
The PHQ-9 is an instrument for screening, diagnosing, monitoring and measuring the severity of depression: The PHQ-9 incorporates self-report questions on 9 specific depression symptoms that align with the DSM-IV depression diagnostic criteria. PHQ-9 scores range from 0-27 and 27 indicates severe depression.
Anxiety as measured using the Generalized Anxiety Disorder 7-Item (GAD-7) Scale
时间窗: From enrollment to the 6-week assessment.
GAD-7 consists total score for the seven items ranges from 0 to 21. Scores of 5, 10, and 15 represent cut points for mild, moderate, and severe anxiety, respectively.
次要结局
未报告次要终点
研究者
Amy S.B. Bohnert
Professor
University of Michigan