CompletedPhase 2

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

United States60 participantsStarted 2023-05-22

Plain-language summary

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.

Who can participate

Age range40 Years – 60 Years

SexFEMALE

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion Criteria: * 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 Exclusion Criteria: * 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

What they're measuring

Mean Within-Subject Difference in Daily Sleep Duration

Timeframe: Baseline (2 weeks) and 2 weeks for each intervention period (4 weeks total for each intervention)

Trial details

NCT IDNCT05789212

SponsorNorthwell Health

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2024-12-15

Results submitted2025-12-17