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Effects of Health and Wellness App on Employee Productivity

Primary Purpose

Sleep Disturbance, Mental Health Wellness 1

Status
Active
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
The Calm App
Sponsored by
Arizona State University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional supportive care trial for Sleep Disturbance

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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

Sites / Locations

  • Arizona State University

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Other

Arm Label

Intervention

Waitlist Control

Arm Description

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).

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.

Outcomes

Primary Outcome Measures

Epworth Sleepiness Scale
Daytime sleepiness
Insomnia Severity Index
Symptoms of insomnia

Secondary Outcome Measures

Pittsburgh Sleep Diaries
Sleep diaries assessing sleep/wake time and sleep quality
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.
Resilience
Resilience will be measured using the Brief Resilience Scale, with scores ranging from 1-5, and a higher score indicates a better outcome.
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.

Full Information

First Posted
November 3, 2021
Last Updated
July 18, 2022
Sponsor
Arizona State University
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1. Study Identification

Unique Protocol Identification Number
NCT05120310
Brief Title
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

2. Study Status

Record Verification Date
July 2022
Overall Recruitment Status
Active, not recruiting
Study Start Date
August 6, 2021 (Actual)
Primary Completion Date
July 2022 (Anticipated)
Study Completion Date
September 2022 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Arizona State University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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 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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Sleep Disturbance, Mental Health Wellness 1

7. Study Design

Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Sequential Assignment
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.
Masking
None (Open Label)
Allocation
Randomized
Enrollment
1029 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Intervention
Arm Type
Experimental
Arm Description
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).
Arm Title
Waitlist Control
Arm Type
Other
Arm Description
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.
Intervention Type
Behavioral
Intervention Name(s)
The Calm App
Intervention Description
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 Outcome Measure Information:
Title
Epworth Sleepiness Scale
Description
Daytime sleepiness
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.
Title
Insomnia Severity Index
Description
Symptoms of insomnia
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.
Secondary Outcome Measure Information:
Title
Pittsburgh Sleep Diaries
Description
Sleep diaries assessing sleep/wake time and sleep quality
Time Frame
Daily for 6 weeks
Title
Productivity
Description
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.
Time Frame
Change from baseline to post-intervention (week 8)
Title
Resilience
Description
Resilience will be measured using the Brief Resilience Scale, with scores ranging from 1-5, and a higher score indicates a better outcome.
Time Frame
Change from baseline to post-intervention (week 8)
Title
Depression, Anxiety, and Stress Scale
Description
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.
Time Frame
Change from baseline to post-intervention (week 8)

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
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
Facility Information:
Facility Name
Arizona State University
City
Phoenix
State/Province
Arizona
ZIP/Postal Code
85004
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
36169994
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.
Results Reference
derived
PubMed Identifier
36169991
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.
Results Reference
derived

Learn more about this trial

Effects of Health and Wellness App on Employee Productivity

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