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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
Study Summary
This study is evaluating whether a coaching program can improve sleep habits in people.
Eligible Conditions
- Sleep Disorder
- 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.
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Epworth Sleepiness Scale
Insomnia Severity Index
Secondary outcome measures
Depression, Anxiety, and Stress Scale
Pittsburgh Sleep Diaries
Productivity
+1 moreTrial 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
Find a Location
Who is running the clinical trial?
Arizona State UniversityLead Sponsor
283 Previous Clinical Trials
108,485 Total Patients Enrolled
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Who else is applying?
What state do they live in?
Kentucky
District of Columbia
Arizona
How old are they?
18 - 65
What site did they apply to?
Arizona State University
What portion of applicants met pre-screening criteria?
Did not meet criteria
Met criteria
How responsive is this trial?
Typically responds via
Email
Average response time
- < 2 Days
Most responsive sites:
- Arizona State University: < 48 hours
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