Clinical trial NCT05120310: Effects of Health and Wellness App on Employee Productivity
Official title: Testing the Effects of the Calm App on Sleep, Mental Health, and Productivity Outcomes in Employees
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Sleep Disturbance
Mental Health Wellness 1
Lead sponsor: Arizona State University
Sponsor class: OTHER
First posted: 2021-11-15
Enrollment: 1029
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: SEQUENTIAL
Intervention model description: There will be two groups: first is the intervention group and the other is a waitlist-control and will receive the intervention after the control portion of the study.
Primary purpose: SUPPORTIVE_CARE

Brief summary: 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.

Detailed description: 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

1. Intervention group (N=2,500): Calm app + concierge (one live 20-minute coaching session)

   a. Calm Coaching for sleep Subsample (N=100): Participants with elevated sleep disturbance (determined as a score of \>10 with the ISI) AND interest in Calm Coaching for sleep will be assigned to the Calm Coaching for sleep Program in addition to having the Calm app + concierge
2. Waitlist control group (N=2,500): Following 8-weeks from the study start date, employee receives access to the Calm app a. Calm Coaching for sleep Subsample (N=100): Participants with elevated sleep disturbance (determined as a score of \>10 with the ISI) AND interest in Calm Coaching for sleep will be assigned to the Calm Coaching for sleep Program in addition to having the Calm app + concierge

Eligibility criteria: Inclusion Criteria:

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

Exclusion Criteria:

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

Primary outcomes:
measure: Epworth Sleepiness Scale
timeFrame: Change from baseline daytime sleepiness at 8-weeks; 8-items; Scores range from 0-24 with higher scores indicating higher levels of daytime sleepiness.
measure: Insomnia Severity Index
timeFrame: Change from baseline symptoms of insomnia at 8-weeks; 7-items; Scores range from 0-28 with higher scores indicating greater symptoms of insomnia.
Secondary outcomes:
measure: Pittsburgh Sleep Diaries
timeFrame: Daily for 6 weeks
measure: Productivity
timeFrame: Change from baseline to post-intervention (week 8)
measure: Resilience
timeFrame: Change from baseline to post-intervention (week 8)
measure: Depression, Anxiety, and Stress Scale
timeFrame: Change from baseline to post-intervention (week 8)
Other outcomes:
Locations:
city: Phoenix
country: United States
facility: Arizona State University
state: Arizona
Study officials:
References:
citation: Espel-Huynh H, Baldwin M, Puzia M, Huberty J. The Indirect Effects of a Mindfulness Mobile App on Productivity Through Changes in Sleep Among Retail Employees: Secondary Analysis. JMIR Mhealth Uhealth. 2022 Sep 28;10(9):e40500. doi: 10.2196/40500.
citation: Huberty JL, Espel-Huynh HM, Neher TL, Puzia ME. Testing the Pragmatic Effectiveness of a Consumer-Based Mindfulness Mobile App in the Workplace: Randomized Controlled Trial. JMIR Mhealth Uhealth. 2022 Sep 28;10(9):e38903. doi: 10.2196/38903.