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Mind-Body Intervention for Sleep Deprivation

Phase 2

Waitlist Available

Led By Karina Davidson, PhD, MASc

Research Sponsored by Northwell Health

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Women (biological sex at birth) aged 40-60 years old

Access to and capable of using a smartphone

Must not have

Unable to complete the study due to cognitive impairment, severe medical or mental illness, or active/prior substance abuse

Men (biological sex at birth)

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 13-16 weeks

Awards & highlights

No Placebo-Only Group

Summary

This trial will test if a Mind-Body Intervention can help women 40-60 in healthcare sleep more. It'll include mindfulness, yoga, and walking over 12 weeks, plus assessments of sleep quality, stress, anxiety, and depression.

Who is the study for?

This trial is for women aged 40-60 working in healthcare with a self-reported history of sleeping less than 7 hours per night for at least three months. They must be experiencing stress and able to use a smartphone and Fitbit regularly. Exclusions include severe illness, substance abuse, inability to walk or do yoga as advised by a doctor, pregnancy, men, those outside the age range, and non-Northwell employees.

What is being tested?

The study tests if Mind-Body Interventions (MBI) like mindfulness, yoga, and guided walking can increase sleep duration over 12 weeks. Participants will first have their baseline sleep measured for two weeks using Fitbit; those adhering well are then randomly assigned one of two sequences of the MBI components.

What are the potential side effects?

Since this trial involves non-invasive practices such as mindfulness exercises, yoga sessions, and guided walks designed to improve sleep patterns among participants without using medication or medical procedures there are no significant side effects expected.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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I am a woman aged between 40 and 60.

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I can use a smartphone.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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I do not have severe mental illness, cognitive issues, or a history of substance abuse that would prevent me from completing the study.

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I am biologically male.

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I am younger than 40 or older than 60 years old.

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I am currently pregnant.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 13-16 weeks

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~13-16 weeks

This trial's timeline: 3 weeks for screening, Varies for treatment, and 13-16 weeks for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Mean Within-Subject Difference in Daily Sleep Duration

Other study objectives

Mean Within-Subject Difference in Anxiety and Depression Scores

Mean Within-Subject Difference in Daily Number of Steps

Mean Within-Subject Difference in Daily Resting Heart Rate

+3 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: Personalized Trial CBAABCExperimental Treatment1 Intervention

Participants in Arm 2 will receive a Personalized Trial comprised of three components delivered in a CBAABC sequence over a total period of 12 weeks, where A-mindfulness, B-yoga, and C-guided walking. Participants in this arm will be prompted to complete 3 x 30-minute intervention sessions weekly during applicable treatment weeks. Interventions will be delivered by a virtual link to online videos recorded by an experienced wellness provider. Participants will be limited to three views of the study-provided intervention content each week.

Group II: Personalized Trial ABCCBAExperimental Treatment1 Intervention

Participants in Arm 1 will receive a Personalized Trial comprised of three components delivered in a ABCCBA sequence over a total period of 12 weeks, where A-mindfulness, B-yoga, and C-guided walking. Participants in this arm will be prompted to complete 3 x 30-minute intervention sessions weekly during applicable treatment weeks. Interventions will be delivered by a virtual link to online videos recorded by an experienced wellness provider. Participants will be limited to three views of the study-provided intervention content each week.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Personalized Trial ABCCBA

2022

Completed Phase 2

~220

Personalized Trial CBAABC

2022

Completed Phase 2

~220