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

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

View full results

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Clinical Phase

PHASE2

Total Enrollment

60 participants

Study Classification

INTERVENTIONAL

Study Start Date

2023-05-22

Study Completion Date

2025-01-03

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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.

Related Clinical Trials

Explore similar clinical trials based on study characteristics and research focus.

Mindfulness Meditation and Insomnia in Alzheimer Disease Caregivers

NCT03538574

Insomnia Chronic

COMPLETED NA

Mindfulness and RelaxationTraining for Insomnia (MRTI) on Postmenopausal Women: a Randomized Clinical Trial.

NCT01593436

Primary Insomnia

COMPLETED NA

Yoga as a Treatment for Insomnia

NCT00033865

Insomnia

COMPLETED PHASE2

Mindfulness-based Stress Reduction and Cognitive Function in Stress and Aging

NCT01693874

Anxiety Disorders Depression

COMPLETED PHASE1/PHASE2

Effect of Mindfulness Training on Sleep and Inflammation Among Older Adults With Sleep Problems

NCT01534338

Sleep Problems Inflammation

COMPLETED PHASE1/PHASE2

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

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.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Sleep Insufficiency

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

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).

Primary Study Purpose

HEALTH_SERVICES_RESEARCH

Blinding Strategy

NONE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

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.

Group Type EXPERIMENTAL

Personalized Trial ABCCBA

Intervention Type 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 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.

Group Type EXPERIMENTAL

Personalized Trial CBAABC

Intervention Type 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.

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

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.

Intervention Type 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.

Intervention Type BEHAVIORAL

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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

Minimum Eligible Age

40 Years

Maximum Eligible Age

60 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

Yes