The Calm App for Insomnia

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

No Placebo-Only Group

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

Insomnia
Mental Health Wellness

Timeline

Screening ~ 3 weeks3 visits

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.

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

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

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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