Protocol for a hybrid type 1 effectiveness-implementation study of mindfulness-based therapy for insomnia in Black women.
Soohyun Nam, Guangyu Tong, Joanne Iennaco...
https://pubmed.ncbi.nlm.nih.gov/41308952Actively Recruiting
Phase Not Applicable
Age: 18Years - 70Years
FEMALE
ID06348082
Implementing Mindfulness Practice to Advance Sleep Health Equity Among Black Women
Led by Yale University · Updated on 2026-02-19
340
Participants Needed
2
Research Sites
8 weeks
Total Duration
On this page
Sponsors
Y
Yale University
Lead Sponsor
D
Department of Health and Human Services
Collaborating Sponsor
AI-Summary
What this Trial Is About
This research aims to promote health and healthcare equity by testing an online mindfulness-based therapy designed to reduce stress and sleep problems linked to heart and metabolic diseases in Black women. The study focuses on understanding barriers and supports for this therapy through community involvement and aims to provide insights for better health policies and practices. The study includes two groups: one receives the mindfulness-based therapy for insomnia (MBTI) in six weekly online sessions led by registered nurses, while the other is a waitlist control group. The MBTI sessions cover mindfulness concepts and practices to improve sleep, with daily meditation expected at home during and after the intervention. Social needs assessments are also part of the program. Participants will be evaluated at the start, week 6, and week 12 for changes in insomnia severity, stress levels, and how acceptable and feasible the intervention is. Treatment sessions will be monitored for fidelity. The total study period includes the intervention and follow-up assessments, with data collection on sleep, stress, and participant feedback to understand the therapy's impact and implementation.
CONDITIONS
Brief Title
Project Women's Insomnia Sleep Health Equity Study (WISHES)
Who Can Participate
Age: 18Years - 70Years
FEMALE
Eligibility Criteria
You may qualify if you...
- Self-identified Black women
- English speaking
- Meet ICSD3 diagnostic criteria for insomnia disorders with difficulty initiating or maintaining sleep despite adequate opportunity, plus at least one daytime impairment
- Insomnia severity index (ISI) score greater than 7
- Sleep onset latency or wake time after sleep onset of 31 minutes or more
- Sleep difficulties occurring 3 or more nights per week
- Sleep problems lasting 3 months or more
You will not qualify if you...
- 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 more than 15 minutes per day
- Diagnosed obstructive sleep apnea, restless legs syndrome, or circadian rhythm disorders (including shift work or medication affecting circadian rhythm)
- Active or terminal cancer
AI-Screening
AI-Powered Screening
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2
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Your Study Journey
Screening
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Treatment
Duration - 6 weeks
Participants randomized to the Mindfulness-based therapy for insomnia (MBTI) group attend 6 weekly online sessions focused on mindfulness concepts and behavioral strategies for sleep. They are expected to practice mindfulness meditation at home daily during this period.
6 weekly sessions (online)
Follow-up
Duration - 6 weeks
Participants continue mindfulness practice at home with reduced daily meditation until the final assessment at 12 weeks.
Assessments at week 12 (online or in-person)
Trial Site Locations
Total: 2 locations
1
Yale School of Nursing
New Haven, Connecticut, United States, 06477
Actively Recruiting
2
Yale School of Nursing Biobehavioral Lab
West Haven, Connecticut, United States, 06516
Actively Recruiting
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Research Team
S
Siobhan Thompson, MPH
S
Soohyun Nam, phD
How is the study designed?
Study Type
INTERVENTIONAL
Masking
QUADRUPLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
SUPPORTIVE_CARE
Number of Arms
2
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