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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT05120310
Other study ID # STUDY00014072
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date August 6, 2021
Est. completion date August 31, 2022

Study information

Verified date March 2024
Source Arizona State University
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


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


Recruitment information / eligibility

Status Completed
Enrollment 1029
Est. completion date August 31, 2022
Est. primary completion date August 31, 2022
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 18 Years and older
Eligibility 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

Study Design


Intervention

Behavioral:
The Calm App
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.

Locations

Country Name City State
United States Arizona State University Phoenix Arizona

Sponsors (1)

Lead Sponsor Collaborator
Arizona State University

Country where clinical trial is conducted

United States, 

Outcome

Type Measure Description Time frame Safety issue
Primary Epworth Sleepiness Scale Daytime sleepiness Change from baseline daytime sleepiness at 8-weeks; 8-items; Scores range from 0-24 with higher scores indicating higher levels of daytime sleepiness.
Primary Insomnia Severity Index Symptoms of insomnia 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 Pittsburgh Sleep Diaries Sleep diaries assessing sleep/wake time and sleep quality Daily for 6 weeks
Secondary Productivity 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. Change from baseline to post-intervention (week 8)
Secondary Resilience Resilience will be measured using the Brief Resilience Scale, with scores ranging from 1-5, and a higher score indicates a better outcome. Change from baseline to post-intervention (week 8)
Secondary Depression, Anxiety, and Stress Scale 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. Change from baseline to post-intervention (week 8)
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