Mind-Body Intervention for Sleep Deprivation

Overseen By Joan Duer-Hefele, RN, MA

Age: 18 - 65

Sex: Female

Trial Phase: Phase 2

Sponsor: Northwell Health

Disqualifiers: Men, Age <40 or >60, Pregnancy, Cognitive impairment, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Prior Safety Data This treatment has passed at least one previous human trial

Compensation: Varies

Number of Visits: 4

Duration: 12 weeks

60 Participants Needed

Trial Summary

What is the purpose of this trial?

The goal of this pilot study is to determine if a personalized trial testing a Mind-Body Intervention (MBI) can produce a meaningful increase in the average daily sleep duration among women 40-60 years of age working in healthcare. A total of 60 eligible participants will be randomized to one of two possible orders of treatment exposure comprised of three components: mindfulness, yoga, and guided walking, each assigned in 2-week block sequences for a total period of 12 weeks. The study will include a 2-week baseline period during which their baseline sleep duration and adherence to the Fitbit wear and survey submission will be assessed. Following the 2-week run-in period, participants deemed eligible and achieved at least 80% adherence of Fitbit wear and survey submission will be randomized to one of the two intervention arms. Exploratory aims include assessments of sleep quality, physiological factors and their direct and indirect relationships with participants' perceived stress, anxiety, and depression.

Research Team

Karina Davidson, PhD, MASc

Principal Investigator

Northwell Health

Eligibility Criteria

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.

Inclusion Criteria

After a two-week trial period, you consistently have short sleep and wear the Fitbit regularly.

You usually sleep less than 7 hours per night for at least 3 months.

I am a woman aged between 40 and 60.

Exclusion Criteria

I cannot wear a Fitbit regularly.

I have no surgeries planned within 6 months from joining the study.

You have not consistently slept very little or forgotten to wear the Fitbit and submit the surveys.

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2 weeks

1 visit (virtual)

Baseline

Participants complete a 2-week run-in period with no intervention to assess baseline sleep duration and adherence to Fitbit wear and survey submission

2 weeks

Virtual monitoring

Treatment

Participants receive a personalized Mind-Body Intervention (MBI) consisting of mindfulness, yoga, and guided walking in 2-week block sequences for a total of 12 weeks

12 weeks

Virtual sessions, 3 times per week

Follow-up

Participants are monitored for changes in sleep duration and quality, and physiological factors over a 2-week period post-intervention

2 weeks

Virtual monitoring

Treatment Details

Interventions

• Personalized Mind-Body Intervention (MBI)

Trial Overview 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.

Participant Groups

Group I: Personalized Trial CBAABC Experimental Treatment 1 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 ABCCBA Experimental Treatment 1 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.

Who Is Running the Clinical Trial?

Northwell Health

Lead Sponsor

Trials

481

Recruited

470,000+

National Institute on Aging (NIA)

Collaborator

Trials

1,841

Recruited

28,150,000+