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Completed

NCT Number: NCT05120310

Effects of Health and Wellness App on Employee Productivity

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.

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Key information

Conditions

Sleep Disturbance Mental Disorders Mental Health Wellness 1 Nervous System Diseases Parasomnias Sleep Wake Disorders

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Arizona State University

Phoenix, Arizona, 85004, United States

About this study

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

  • 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

  • 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

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

The Calm App

Behavioral

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). Participants will be asked to download the Calm app to their mobile phone. The Calm Coaching for sleep program is administered by Calm for six weeks. Participants are asked to complete weekly modules and interact with a coach to help them improve their sleep. Participants also complete a sleep diary throughout the program.

Primary outcomes

  1. Epworth Sleepiness Scale

    Time frame: 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

  2. Insomnia Severity Index

    Time frame: 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

Secondary outcomes

  1. Pittsburgh Sleep Diaries

    Time frame: Daily for 6 weeks

    Sleep diaries assessing sleep/wake time and sleep quality

  2. Productivity

    Time frame: Change from baseline to post-intervention (week 8)

    Productivity will be measured using the Work Productivity and Activity Impairment Questionnaire. Scores on the WPAI:GH are provided as a percentage with higher numbers indicating greater impairment and less productivity.

  3. Resilience

    Time frame: Change from baseline to post-intervention (week 8)

    Resilience will be measured using the Brief Resilience Scale, with scores ranging from 1-5, and a higher score indicates a better outcome.

  4. Depression, Anxiety, and Stress Scale

    Time frame: Change from baseline to post-intervention (week 8)

    Depression, Anxiety, and Stress Scale will be measured using the Depression, Anxiety, and Stress Scale (DASS-21) with lower scores in the three categories indicates a better outcome.

Sponsors and collaborators

Lead sponsor

Arizona State University

Other

Registry information

Official study title

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

Important dates

Study start
2021
Primary completion
2022
Study completion
2022
First posted
Nov 15, 2021
Registry last updated
Mar 26, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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