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

NCT05789212 | Completed Phase 2 Results

• 2 other identifiers: 22-0770P30AG063786-01
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Sleep Insufficiency

Keywords

Sleep duration; Sleep quality; Anxiety; Depression

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (6)

• Mean Within-Subject Difference in Daily Sleep Latency

  13-16 weeks

• Mean Within-Subject Difference in Daily Sleep Efficiency

  13-16 weeks

• Mean Within-Subject Difference in Daily Resting Heart Rate

  13-16 weeks

Study Arms (2)

Personalized Trial ABCCBA

EXPERIMENTAL

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

Personalized Trial CBAABC

EXPERIMENTAL

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

Interventions

Personalized Trial ABCCBA BEHAVIORAL

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.

Personalized Trial ABCCBA

Personalized Trial CBAABC BEHAVIORAL

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.

Personalized Trial CBAABC

Eligibility Criteria

• Age: 40 Years - 60 Years
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

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

Sponsors & Collaborators

• National Institute on Aging (NIA): collaborator
• Northwell Health: lead

Study Sites (1)

Institute of Health System Science

New York, New York, 10022, United States

Location

MeSH Terms

Conditions

Sleep Deprivation; Sleep Initiation and Maintenance Disorders; Anxiety Disorders; Depression

Condition Hierarchy (Ancestors)

Dyssomnias; Sleep Wake Disorders; Nervous System Diseases; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Mental Disorders; Sleep Disorders, Intrinsic; Behavioral Symptoms; Behavior

Results Point of Contact

• Title: Dr. Codruta Chiuzan
• Organization: Northwell Health

cchiuzan@northwell.edu

646-766-7153

Study Officials

• Karina Davidson, PhD, MASc

  Northwell Health

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Mixed between and within (Crossover) participant assignment. The study uses a between participant randomization; each of the two arms have a multiple crossover design (with different intervention orders to the crossover).

Study Record Dates

• First Submitted: March 13, 2023
• First Posted: March 29, 2023
• Study Start: May 22, 2023
• Primary Completion: December 15, 2024
• Study Completion: January 3, 2025
• Last Updated: February 2, 2026
• Results First Posted: February 2, 2026

Record last verified: 2026-01

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP
• 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.
• Access Criteria: All data and supporting information will be stored on the Open Science Framework, a free web application with no access restrictions.

Locations

US (1)