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

A Personalized (N-of-1) Trial for Testing the Effect of a Mind-Body Intervention (MBI) on Sleep Duration and Quality in Middle-Aged Women Working in Healthcare

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.

Study Overview

• Status: Completed
• Conditions: Sleep Insufficiency
• Intervention / Treatment: Behavioral: Personalized Trial ABCCBA; Behavioral: Personalized Trial CBAABC

Detailed Description

The goal of this pilot study is to determine if a personalized trial (N-of-1) employing a Mind-Body Intervention (MBI) can produce a meaningful increase in sleep duration among women 40-60 years of age working at Northwell Health. A total of 60 women with a history of short sleep duration (defined as an average <7h per 24-h period for at least three months) will be enrolled over a period of two years. Participants will complete a 2-week run-in period with no intervention, during which their baseline sleep duration and adherence to the Fitbit wear and survey submission will be assessed. Adherence to Fitbit wear will be defined as recorded activity of greater than 12 hours a day, and recorded sleeping activity greater than 180 minutes in total. Survey adherence will be defined as submission of a given survey. Participants who achieve at least 80% adherence of Fitbit wear and survey submission during baseline period will be randomized to Arm 1 (N=30) or Arm 2 (N=30). Each arm will receive a personalized intervention comprised of three components: mindfulness, yoga and guided walking assigned in 2-week block sequences for a total period of 12 weeks. During each 2-week block, participants will be prompted to complete 3 x 30-minute intervention sessions weekly. 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. Changes in average daily sleep duration will be calculated for each participant based on daily measurements between the run-in and each treatment period. The Fitbit devices will also record sleep quality components (sleep onset, sleep staging, and overall sleep score) and physiological factors (breathing/resting heart rate, heart rate variability (HRV) and activity). We will also examine the direct and indirect relationships between perceived stress, anxiety and depression, and sleep quality assessed pre, during (bi-weekly), and post MBI. Enrollment will continue until up to 60 participants have been randomized. Following the intervention, all participants will be assessed over a 2-week follow-up period to allow for a personalized report of their observed data to be generated.

• Study Type: Interventional
• Enrollment (Actual): 60
• Phase: Phase 2

Contacts and Locations

Study Locations

• United States
  • New York
    • New York, New York, United States, 10022
      • Institute of Health System Science

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 40 years to 60 years (Adult)
• Accepts Healthy Volunteers: Yes

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Health Services Research
• Allocation: Randomized
• Interventional Model: Crossover Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Personalized Trial ABCCBA; 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.	Behavioral: Personalized Trial ABCCBA; Participants will receive links for 30-minute videos for all three interventions, for 2 weeks each, 3 times per week, in a specified order (ABCCBA), where A-mindfulness, B-yoga, and C-guided walking.
Experimental: Personalized Trial CBAABC; 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.	Behavioral: Personalized Trial CBAABC; Participants will receive links for 30-minute videos for all three interventions, for 2 weeks each, 3 times per week, in a specified order (CBAABC), where A-mindfulness, B-yoga, and C-guided walking.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Mean Within-Subject Difference in Daily Sleep Duration	The effect of the personalized MBI intervention on individual's sleep duration will be assessed in each arm separately. Participants' daily sleep duration will be measured objectively using Fitbit devices and by self-reported questionnaires. Individual changes in the average daily sleep durations between the run-in and each treatment period will be reported using means and 95% CIs. Bland-Altman plots will be constructed to visualize agreement between Fitbit reported and self-reported sleep duration. The effects of treatment on sleep duration will be assessed using GEE with an unstructured variance-covariance matrix for measures on the same day to that night's sleep. This model accounts for possible autocorrelation and linear trends between sleep duration across time. A change between time points is reported (e.g., baseline (2 weeks) and 2 weeks for each intervention period (4 weeks per intervention)) as a value for each intervention period minus value at baseline.	Baseline (2 weeks) and 2 weeks for each intervention period (4 weeks total for each intervention)

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Mean Within-Subject Difference in Anxiety and Depression Scores	Participant's anxiety and depressive disorder scores will be assessed using the Patient Health Questionnaire (PHQ-4), a self-report version of the Primary Care Evaluation of Mental Disorders (PRIME-MD) on a scale of 0 to 3 for a total of four items. Total score will be determined by adding together the scores of each of the 4 items. Scores are rated as normal (0-2), mild (3-5), moderate (6-8), and severe (9-12). Total score ≥3 for first 2 questions suggests anxiety. Total score ≥3 for last 2 questions suggests depression. PHQ-4 will be evaluated pre-intervention (run-in), bi-weekly during the intervention, and post-intervention. Individual changes in the average PHQ-4 scores between the run-in and each treatment period will be reported using means (95% CIs). The role of anxiety and depression as a potential mediator (M) between perceived stress (X) and sleep score (Y), will be determined by mixed effects regression models.	13-16 weeks
Mean Within-Subject Difference in Daily Sleep Latency	Sleep latency is an important parameter in a sleep study. The duration of time between when the lights are turned off (lights out) as the patient attempts to sleep, until the time patient actually falls asleep will be reported as sleep latency and aggregated daily using Fitbit devices. The effect of the personalized MBI intervention on individual's sleep latency will be assessed in each arm separately. Individual changes in the average daily sleep latency between the run-in and each treatment period will be reported using means (95% CIs) and modeled using Generalized estimating equations (GEE).	13-16 weeks
Mean Within-Subject Difference in Daily Sleep Efficiency	Sleep efficiency (SE) is an indicator of sleep quality. SE is commonly defined as the ratio of total sleep time (TST) to time in bed (TIB). Values (as percentages) greater than or equal to 85% indicate good sleep quality (Ohayon et al., 2017 [PMID: 28346153]). SE will be recorded and aggregated daily using Fitbit devices. The effect of the personalized MBI intervention on individual's SE be assessed in each arm separately. Individual changes in the average daily sleep efficiency between the run-in and each treatment period will be reported using means (95% CIs) and modeled using Generalized estimating equations (GEE).	13-16 weeks
Mean Within-Subject Difference in Daily Resting Heart Rate	Fitbit calculates the resting heart rate by measuring the heart rate when it detects sleep, and by measuring it throughout the day while an individual is but inactive (no steps detected). Resting heart rate will be recorded and aggregated daily using Fitbit devices. The effect of the personalized MBI intervention on individual's resting heart rate will be assessed in each arm separately. Individual changes in the average resting heart rate between the run-in and each treatment period will be reported using means (95% CIs) and modeled using Generalized estimating equations (GEE).	13-16 weeks
Mean Within-Subject Difference in Daily Number of Steps	The number of steps per day (physical activity) will be recorded and aggregated daily using Fitbit devices. The effect of the personalized MBI intervention on individual's number of steps per day will be assessed in each arm separately. Individual changes in the daily average number of steps between the run-in and each treatment period will be reported using means (95% CIs) and modeled using Generalized estimating equations (GEE).	13-16 weeks
Mean Within-Subject Difference in Perceived Stress Score	Participant's perceived stress score will be measured using the Perceived Stress Scale (PSS) (scale 0 to 40) and the Ecological Momentary Assessment (EMA) Stress questionnaire (scale 0 to 10). PSS and EMA will be evaluated pre-intervention (run-in), bi-weekly during the intervention, and post-intervention. Individual changes in the average PSS and EMA scores between the run-in and each treatment period will be reported using means (95% CIs).	13-16 weeks

Collaborators and Investigators

• Sponsor: Northwell Health
• Collaborators: National Institute on Aging (NIA)
• Investigators: Principal Investigator: Karina Davidson, PhD, MASc, Northwell Health

Study record dates

Study Major Dates

• Study Start (Actual): May 22, 2023
• Primary Completion (Actual): December 15, 2024
• Study Completion (Actual): January 3, 2025

Study Registration Dates

• First Submitted: March 13, 2023
• First Submitted That Met QC Criteria: March 28, 2023
• First Posted (Actual): March 29, 2023

Study Record Updates

• Last Update Posted (Actual): February 2, 2026
• Last Update Submitted That Met QC Criteria: January 15, 2026
• Last Verified: January 1, 2026

More Information

Terms related to this study

• Keywords: Depression; Anxiety; Sleep quality; Sleep duration
• Additional Relevant MeSH Terms: Neurologic Manifestations; Nervous System Diseases; Mental Disorders; Behavioral Symptoms; Sleep Wake Disorders; Sleep Disorders, Intrinsic; Dyssomnias; Pathological Conditions, Signs and Symptoms; Behavior; Signs and Symptoms; Anxiety Disorders; Depression; Sleep Initiation and Maintenance Disorders; Sleep Deprivation
• Other Study ID Numbers: 22-0770; P30AG063786-01 (U.S. NIH Grant/Contract)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: All collected individual participant data (IPD) will be de-identified and pooled before sharing on the Open Science Framework, along with a data dictionary.
• IPD Sharing Time Frame: The study protocol, including the statistical analysis plan, will be made available in addition to the informed consent form following completion of recruitment but prior to publication of any data from the current study. De-identified, pooled individual participant data will be made available within a year of final participant data collection. We anticipate this data to be available on the Open Science Framework platform indefinitely.
• IPD Sharing Access Criteria: All data and supporting information will be stored on the Open Science Framework, a free web application with no access restrictions.
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL; SAP

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No