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Behavioral Intervention

The Calm App for Sleep Disorder

N/A
Waitlist Available
Research Sponsored by Arizona State University
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up change from baseline symptoms of insomnia at 8-weeks; 7-items; scores range from 0-28 with higher scores indicating greater symptoms of insomnia.
Awards & highlights

Summary

This trial tests the Calm app and a short coaching session to help employees with stress and sleep issues. Some will get extra sleep coaching. The app uses mindfulness techniques to improve relaxation and sleep. The Calm app is a commercially available mindfulness meditation mobile app that has been tested in various studies for its effectiveness in improving sleep and mental health.

Eligible Conditions
  • Sleep Disorder
  • Mental Health Wellness

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~change from baseline daytime sleepiness at 8-weeks; 8-items; scores range from 0-24 with higher scores indicating higher levels of daytime sleepiness.
This trial's timeline: 3 weeks for screening, Varies for treatment, and change from baseline daytime sleepiness at 8-weeks; 8-items; scores range from 0-24 with higher scores indicating higher levels of daytime sleepiness. for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Epworth Sleepiness Scale
Insomnia Severity Index
Secondary study objectives
Depression, Anxiety, and Stress Scale
Pittsburgh Sleep Diaries
Productivity
+1 more

Trial Design

2Treatment groups
Experimental Treatment
Group I: Waitlist ControlExperimental Treatment1 Intervention
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.
Group II: InterventionExperimental Treatment1 Intervention
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).
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
The Calm App
2021
N/A
~1030

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Who is running the clinical trial?

Arizona State UniversityLead Sponsor
294 Previous Clinical Trials
106,401 Total Patients Enrolled
~252 spots leftby Sep 2025
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