A Personalized Mind-Body Intervention (MBI) for Improving Sleep Among Women Working in Healthcare

Completed · Phase 2

Conditions studied: Sleep Insufficiency

In brief

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.

Key facts

Study ID

NCT05789212

Run by

Northwell Health

People needed

60

Starts

2023-05-22

Expected to finish

2025-01-03

Last updated by the study team

2026-02-02

Who can join

Age: 40 and older, up to 60. Sex: female. Healthy volunteers: accepted.

You may qualify if…

• Women (biological sex at birth)
• Age 40-60 years old
• Northwell employee/affiliate
• Self-reported history of short sleep duration (<7h per 24-h period) for at least 3 months
• After 2-week run-in, Fitbit-verified short sleep duration and ≥80% adherence of Fitbit wear and survey submission
• Self-report of perceived stress ≥18 using the Perceived Stress Scale (PSS)
• Access to and capable of using a smartphone
• Can regularly wear a Fitbit device

You may not qualify if…

• Men (biological sex at birth)
• Age < 40 or >60 years old
• Women who are pregnant
• Not a Northwell employee/affiliate
• No history of short sleep duration or non-adherent to the Fitbit wear and survey submission
• Self-report of perceived stress <18 using the Perceived Stress Scale (PSS)
• Does not own or cannot regularly access a smartphone
• Cannot regularly wear a Fitbit device
• Unable to complete the study due to cognitive impairment, severe medical or mental illness, or active/prior substance abuse
• Planned surgeries 6 months from study start date
• Participants who have been previously told by a doctor/clinician they have mobility limiting health conditions and/or to not engage in walking 30 minutes, three times per week or yoga

Where it is running

• Institute of Health System Science — New York, New York, United States

Full record on ClinicalTrials.gov

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