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临床试验/NCT05120310
NCT05120310已完成不适用

Testing the Effects of the Calm App on Sleep, Mental Health, and Productivity Outcomes in Employees

Arizona State University1 个研究点 分布在 1 个国家目标入组 1,029 人开始时间: 2021年8月6日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
已完成
入组人数
1,029
试验地点
1
主要终点
Epworth Sleepiness Scale

研究概览

简要总结

The purpose of this study is to test the effects of using the Calm app + coaching concierge (one 20-min session) and/or Calm Coaching for sleep program on sleep, mental health, and work productivity outcomes in employees.

Employees (N=5,000) will be randomized into one of two groups for 8-weeks.

详细描述

Workplace stress is highly prevalent and is linked to poor health outcomes including depression and anxiety. Depression impacts a person's physical ability to complete job tasks about 20% of the time while reducing cognitive performance 35% of the time. Mental health issues are not often properly identified and less than half of people receive treatment.

The Calm app is a mindfulness meditation mobile app and has been evidenced to reduce stress, improve sleep, and reduce anxiety/depressive symptoms in a range of populations (e.g., college students, cancer patients, sleep-disturbed adults). The Calm app provides daily, 10-minute, guided meditations grounded in mindfulness-based stress reduction (MBSR) and Vipassana meditation. Uniquely, the Calm app also offers "Sleep Stories", narrated fictional tales that use mindfulness- inspired techniques to help users sleep. However, the effects of the Calm app in employees among worksites has not yet been explored.

The purpose of this study is to test the effects of using the Calm app + coaching concierge (one 20-min session) and/or Calm Coaching for sleep program on sleep, mental health, and work productivity outcomes in employees.

Employees (N=5,000) will be randomized into one of two groups for 8-weeks.

The research team will randomize the employee sites into one of two groups

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Sequential
主要目的
Supportive Care
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

  • •18 years or older
  • •Employee of company
  • •Only English speakers
  • •Willing to download the Calm app to their smartphone

排除标准

  • •Greater than 60 minutes/month of meditation for the past six months

研究组 & 干预措施

Intervention

Experimental

Participants will be asked to use the Calm app for at least 10 minutes per day for eight weeks. They will also be asked to schedule one live 20-minute coaching session with a Calm Coach within the first week of the eight-week intervention to help identify areas for health behavior improvements (i.e., Calm Concierge).

- Calm Coaching for sleep Subsample (N=100): A random subsample of eligible participants, based on their ISI scores, will be invited to use the Calm Coaching for Sleep Program (using Healthie platform).

干预措施: The Calm App (Behavioral)

Waitlist Control

Other

Participants will be instructed to not participate in any mindfulness meditation activities for eight weeks. The research team will send the participant study instructions. At the end of eight weeks participants will be given access to the Calm app and will be able to schedule one live 20-minute coaching session with a Calm Coach.

- Calm Coaching for sleep Subsample (N=100): A random subsample of eligible participants, based on their ISI scores, will be invited to use the Calm Coaching for sleep Program. The Calm Coaching for sleep program is administered by Calm for six weeks.

干预措施: The Calm App (Behavioral)

结局指标

主要结局

Epworth Sleepiness Scale

时间窗: Change from baseline daytime sleepiness at 8-weeks; 8-items; Scores range from 0-24 with higher scores indicating higher levels of daytime sleepiness.

Daytime sleepiness

Insomnia Severity Index

时间窗: Change from baseline symptoms of insomnia at 8-weeks; 7-items; Scores range from 0-28 with higher scores indicating greater symptoms of insomnia.

Symptoms of insomnia

次要结局

  • Productivity(Change from baseline to post-intervention (week 8))
  • Pittsburgh Sleep Diaries(Daily for 6 weeks)
  • Resilience(Change from baseline to post-intervention (week 8))
  • Depression, Anxiety, and Stress Scale(Change from baseline to post-intervention (week 8))

研究者

申办方类型
Other
责任方
Sponsor

研究点 (1)

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