Healthy Mind Healthy You: A Study of Mindfulness
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 4,412
- 试验地点
- 2
- 主要终点
- Estimated Weekly Change on World Health Organization-5 (WHO-5)
研究概览
简要总结
Most people experience stress at some point in their lives. Stress, especially when severe, can not only make you feel bad, it can also worsen existing health problems like heart disease, type 2 diabetes, obesity, high blood pressure, depression, and even cancer. Healthy Mind, Healthy You is a new study about how mindfulness can help people cope with stress. Funded by the Patient Centered Outcome Research Institute (PCORI) and involving 19 Patient Powered Research Networks (PPRNs), Healthy Mind Healthy You will be able to study the effects of mindfulness on a wide variety of populations and conditions.
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
- 是
入选标准
- •Must be a member (patient/member of special population or caregiver) of one of the 19 PCORI Patient-Powered Research Networks (PPRN)
- •Must be age 18 or older
排除标准
- •Under the age of 18 years
- •Unable to read, understand, and/or participate in mindfulness exercises
结局指标
主要结局
Estimated Weekly Change on World Health Organization-5 (WHO-5)
时间窗: Baseline to 8 Weeks, Baseline to 20 Weeks
The WHO-5 is a 5-item questionnaire that assesses well-being over the prior two weeks. Scores range 0-100 with higher scores reflecting greater well-being. We used linear mixed effects models to examine the effect of the interventions on weekly WHO-5 scores. Change = estimated average weekly change during time frame.
次要结局
- Estimated Weekly Change on Perceived Stress Scale (PSS)(Baseline to 8 Weeks, Baseline to 20 Weeks)
- Estimated Weekly Change on Patient Reported Outcomes Measurement Information System (PROMIS): Ability to Participate in Social Roles and Activities Short Form(Baseline to 8 Weeks, Baseline to 20 Weeks)
- Estimated Weekly Change on Five Facet Mindfulness Questionnaire (FFMQ) Abbreviated(Baseline to 8 Weeks, Baseline to 20 Weeks)
- Estimated Weekly Change on Patient Reported Outcomes Measurement Information System (PROMIS): Emotional Distress-Depression Short Form(Baseline to 8 Weeks, Baseline to 20 Weeks)
- Estimated Weekly Change on Patient Reported Outcomes Measurement Information System (PROMIS): Emotional Distress-Anxiety Short Form(Baseline to 8 Weeks, Baseline to 20 Weeks)
研究者
Andrew A. Nierenberg, MD
Director, Dauten Family Center for Bipolar Treatment Innovation
Massachusetts General Hospital