Project Movement/Daily Move Feasibility
Testing the Feasibility of Brief Daily App-Based Mindful Movements in US Adults
研究概览
详细说明
Generalized stress among adults is an increasingly problematic concern, particularly in recent years due to the COVID-19 pandemic. According to the Stress in America 2020 data, Americans are still struggling to cope with the disruptions that the pandemic has caused, and nearly 8 in 10 adults (78%) say that the COVID-19 pandemic is a significant source of stress in their life. This stress from the COVID-19 pandemic is in addition to previous sources of stress that impacted American adults, including things such as health care, mass shootings, global climate change, and more. Additionally, rising concerns over racism and racially-driven acts of violence has impacted racial-ethnic minorities and led to rising rates of stress over discrimination. In 2021, 44% of people of color said that discrimination was a significant source of stress in their life, compared with 38% back in 2019. The currently proposed study aims to include American adults with elevated levels of stress, with 60% of the recruited sample targeting racial-ethnic minorities.
The investigators have previously conducted multiple feasibility and pilot studies investigating the use of the mobile meditation app, Calm, on various mental health outcomes in a diverse range of adults (cancer patients, adults with sleep disturbances, etc.). The investigators have found the Calm meditation app to be both feasible and beneficial for adults on a range of mental health outcomes, including stress-related outcomes. Although there is a growing body of evidence to describe the benefits of short, daily meditations on stress and other mental health outcomes in adults, there are currently no investigations that have been done to examine the feasibility or impact of short, daily app-based mindful movement exercises on stress in adults. It is for these reasons that the primary purpose of this study is to test the feasibility of the Calm's "Daily Move" component on stressed adults.
研究类型
注册 (实际的)
阶段
- 不适用
联系人和位置
学习地点
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California
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San Francisco、California、美国、94105
- Calm, Inc.
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参与标准
资格标准
适合学习的年龄
接受健康志愿者
有资格学习的性别
描述
Inclusion Criteria:
- Aged 18 years or older
- Score of 6 or greater on the Perceived Stress Scale-4
Exclusion Criteria:
- Subscribe to Calm or use Calm
- Live outside of the United States of America
- Unable to read or understand English
学习计划
研究是如何设计的?
设计细节
- 主要用途:支持治疗
- 分配:随机化
- 介入模型:并行分配
- 屏蔽:双倍的
武器和干预
参与者组/臂 |
干预/治疗 |
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实验性的:Daily Move
Participants (n=107) will be provided free access to and asked to register for the consumer-based mobile meditation app, Calm, on their phone.
Participants will then receive an email containing one year of free access to Calm.
Participants will be asked to use the Daily Move component on the Calm app for ~10 minutes per day for 8 weeks.
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The Daily Move is a series of short, 5-min videos outlining mindful movement exercises.
The Daily Move is part of the Calm app's library of content.
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无干预:Usual Care
Participants (n=107) will be asked to continue with usual care/routine and complete survey measures at each time point.
Participants will be provided with access to the intervention after their study participation.
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研究衡量的是什么?
主要结果指标
结果测量 |
措施说明 |
大体时间 |
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Stress
大体时间:Changes in stress will be measured at baseline, week 2, week 4, week 6, and week 8 (post-intervention). The PSS includes 10 items with total scores ranging from 0-40.
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Stress will be measured using the Perceived Stress Scale (PSS).
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Changes in stress will be measured at baseline, week 2, week 4, week 6, and week 8 (post-intervention). The PSS includes 10 items with total scores ranging from 0-40.
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次要结果测量
结果测量 |
措施说明 |
大体时间 |
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Anxiety
大体时间:Changes in anxiety will be measured at baseline, week 4, and week 8 (post-intervention). The HADS includes seven items assessing anxiety symptoms with a total score range of 0-21.
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Anxiety will be measured using the Hospital Anxiety and Depression Scale (HADS).
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Changes in anxiety will be measured at baseline, week 4, and week 8 (post-intervention). The HADS includes seven items assessing anxiety symptoms with a total score range of 0-21.
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Depression
大体时间:Changes in depression will be measured at baseline, week 4, and week 8 (post-intervention). The HADS includes seven items assessing depressive symptoms with a total score range of 0-21.
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Depression will be measured using the Hospital Anxiety and Depression Scale (HADS).
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Changes in depression will be measured at baseline, week 4, and week 8 (post-intervention). The HADS includes seven items assessing depressive symptoms with a total score range of 0-21.
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Mindfulness
大体时间:Changes in mindfulness will be measured at baseline, week 4, and week 8 (post-intervention). The MAAS is a 15-item scale with total possible scores ranging from 15-90, with higher scores indicating greater mindfulness.
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Mindfulness will be measured using the Mindful Attention Awareness Scale (MAAS).
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Changes in mindfulness will be measured at baseline, week 4, and week 8 (post-intervention). The MAAS is a 15-item scale with total possible scores ranging from 15-90, with higher scores indicating greater mindfulness.
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Mood
大体时间:Changes in mood will be measured at baseline, week 4, and week 8 (post-intervention). The POMS is a 65-item scale with six sub scales. Each item is scored on a 0-4 scale, yielding a total possible score range of -24 to 177.
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Mood will be measured using the Profile of Mood States (POMS).
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Changes in mood will be measured at baseline, week 4, and week 8 (post-intervention). The POMS is a 65-item scale with six sub scales. Each item is scored on a 0-4 scale, yielding a total possible score range of -24 to 177.
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其他结果措施
结果测量 |
措施说明 |
大体时间 |
---|---|---|
Study Satisfaction
大体时间:Study satisfaction will be measured at week 8 (post-intervention).
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Study satisfaction will be measured using an investigator-developed satisfaction survey.
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Study satisfaction will be measured at week 8 (post-intervention).
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合作者和调查者
调查人员
- 研究主任:Calm、Calm.com, Inc.
研究记录日期
研究主要日期
学习开始 (实际的)
初级完成 (实际的)
研究完成 (实际的)
研究注册日期
首次提交
首先提交符合 QC 标准的
首次发布 (实际的)
研究记录更新
最后更新发布 (实际的)
上次提交的符合 QC 标准的更新
最后验证
更多信息
与本研究相关的术语
其他研究编号
- Calm2021-105
计划个人参与者数据 (IPD)
计划共享个人参与者数据 (IPD)?
药物和器械信息、研究文件
研究美国 FDA 监管的药品
研究美国 FDA 监管的设备产品
此信息直接从 clinicaltrials.gov 网站检索,没有任何更改。如果您有任何更改、删除或更新研究详细信息的请求,请联系 register@clinicaltrials.gov. clinicaltrials.gov 上实施更改,我们的网站上也会自动更新.
Calm Daily Move的临床试验
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VA Office of Research and Development完全的
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Birmingham Community Healthcare NHSNSA, LLC完全的
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Brandon HathornBaylor Heart and Vascular Institute Cardiovascular Research Review Committee完全的冠状动脉疾病 | 心脏瓣膜疾病
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Barron Associates, Inc.Duke University; University of Virginia招聘中