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

Northwell Health

Status and phase: Completed; Phase 2

Conditions: Sleep Insufficiency

Treatments: Behavioral: Personalized Trial ABCCBA; Behavioral: Personalized Trial CBAABC

Study type: Interventional

Funder types: Other; NIH

Identifiers

NCT05789212

P30AG063786-01 (U.S. NIH Grant/Contract)

22-0770

Details and patient eligibility

About

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.

Full 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.

Enrollment: 60 patients

Sex: Female

Ages: 40 to 60 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Health Services Research

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: None (Open label)

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60 participants in 2 patient groups

Personalized Trial ABCCBA

Experimental group

Description:

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.

Treatment:

Behavioral: Personalized Trial ABCCBA

Personalized Trial CBAABC

Experimental group

Description:

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.

Treatment:

Behavioral: Personalized Trial CBAABC