NCT05120310

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
1,029

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Aug 2021

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

August 6, 2021

Completed
3 months until next milestone

First Submitted

Initial submission to the registry

November 3, 2021

Completed
12 days until next milestone

First Posted

Study publicly available on registry

November 15, 2021

Completed
10 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 31, 2022

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

August 31, 2022

Completed
Last Updated

March 26, 2024

Status Verified

March 1, 2024

Enrollment Period

1.1 years

First QC Date

November 3, 2021

Last Update Submit

March 25, 2024

Conditions

Outcome Measures

Primary Outcomes (2)

  • 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.

  • 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 Outcomes (4)

  • Pittsburgh Sleep Diaries

    Daily for 6 weeks

  • Productivity

    Change from baseline to post-intervention (week 8)

  • Resilience

    Change from baseline to post-intervention (week 8)

  • Depression, Anxiety, and Stress Scale

    Change from baseline to post-intervention (week 8)

Study Arms (2)

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).

Behavioral: The Calm App

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.

Behavioral: The Calm App

Interventions

The Calm AppBEHAVIORAL

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.

InterventionWaitlist Control

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Arizona State University

Phoenix, Arizona, 85004, United States

Location

Related Publications (2)

  • 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.

  • 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.

MeSH Terms

Conditions

Parasomnias

Condition Hierarchy (Ancestors)

Sleep Wake DisordersNervous System DiseasesMental Disorders

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
SUPPORTIVE CARE
Intervention Model
SEQUENTIAL
Model Details: 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.
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

November 3, 2021

First Posted

November 15, 2021

Study Start

August 6, 2021

Primary Completion

August 31, 2022

Study Completion

August 31, 2022

Last Updated

March 26, 2024

Record last verified: 2024-03

Data Sharing

IPD Sharing
Will not share

Locations