Online mindfulness sleep program for Black women to improve sleep and cardiometabolic health
Implementing Mindfulness Practice to Advance Sleep Health Equity Among Black Women
This project will test whether an online mindfulness-based sleep program helps Black women with insomnia sleep better and reduce stress-related heart and metabolic risk.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 340 (estimated) |
| Ages | 18 Years to 70 Years |
| Sex | Female |
| Sponsor | Yale University Academic / other |
| Locations | 2 sites (New Haven, Connecticut and 1 other locations) |
| Trial ID | NCT06348082 on ClinicalTrials.gov |
What this trial studies
The research uses community-engaged methods to develop equity-focused strategies and then runs a pragmatic randomized controlled trial (Hybrid Type 1) comparing an online mindfulness-based therapy for insomnia (MBTI) delivered by registered nurses to a waitlist control. Phases 1–2 identify multi-level barriers and facilitators and refine implementation strategies with a community advisory board including community organizations, church networks, clinicians, and community health workers. In phase 3, specialists screen for social needs and RNs deliver the online MBTI in community settings, with outcomes tracking sleep, stress, and cardiometabolic health metrics. The study emphasizes equity-relevant metrics and implementation determinants to inform policy and broader dissemination.
Who should consider this trial
Good fit: Ideal candidates are English-speaking self-identified Black women with chronic insomnia meeting ICSD-3 criteria (ISI > 7, sleep latency or wake after sleep onset ≥ 31 minutes, occurring ≥ 3 nights/week for ≥ 3 months).
Not a fit: People with uncontrolled psychosis or significant unstable mental health or substance use under active care, those with substantial current meditation practice, or those with untreated obstructive sleep apnea, restless legs syndrome, or circadian rhythm disorders (including shift workers) are unlikely to benefit or be eligible.
Why it matters
Potential benefit: If successful, the program could improve sleep and reduce stress-related cardiometabolic risk for Black women while providing a scalable, equity-focused delivery model.
How similar studies have performed: Prior mindfulness-based insomnia programs have shown sleep improvements in other groups, but delivering an equity-focused online MBTI specifically for Black women in community settings is relatively novel.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * self-identified Black women * English speaking * meet ICSD3 diagnostic criteria for insomnia disorders, defined as difficulty initiating or maintaining sleep that occurs despite adequate opportunity to sleep with at least one associated daytime impairment symptom (ISI \> 7) * additional quantitative insomnia criteria based on research recommendations and the new ICSD3: (a) severity of sleep onset latency or wake time after sleep onset of ≥31 min, (b) occurring ≥3 nights a week, and (c) for ≥ 3 months. Exclusion Criteria: * Psychosis or unstable/significant depression, anxiety, or substance abuse under active care (more than 1 monthly mental healthcare visit or requiring more than 1 psychotropic medicine daily) * significant current practice of any form of meditation (\>15min per day) * obstructive sleep apnea (OSA), restless legs syndrome (RLS), or circadian rhythm related condition (shift worker, use of medication that influence circadian rhythm, e.g., Parkinson's disease) * active or terminal cancer.
Where this trial is running
New Haven, Connecticut and 1 other locations
- Yale School of Nursing — New Haven, Connecticut, United States (Recruiting)
- Yale School of Nursing Biobehavioral Lab — West Haven, Connecticut, United States (Recruiting)
Study contacts
- Principal investigator: Soohyun Nam, PhD, APRN, ANP-BC, FAHA, FAAN — Yale University School of Nursing
- Study coordinator: Siobhan Thompson, MPH
- Email: siobhan.thompson@yale.edu
- Phone: 203.645.7647
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.