Project Women's Insomnia Sleep Health Equity Study (WISHES)
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Mindfulness-based therapy for insomnia (MBTI).
- Who it may be relevant to
- Registry conditions: Insomnia, Sleep Health, Cardiometabolic Health. Basic parameters: 18 years — 70 years · Female.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- United States
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
Official title
Implementing Mindfulness Practice to Advance Sleep Health Equity Among Black Women
Overview
The purpose of this study is to achieve health and healthcare equity by implementing an equity-focused, mindfulness-based sleep intervention to reduce stress and sleep deficiency-related cardiometabolic disease burden in Black women.
Detailed description
In phases 1 and 2, the investigator will identify multi-level barriers and facilitators to implementing the online mindfulness-based therapy for insomnia (MBTI) through an equity lens using community-engaged research with key stakeholders. The investigators will then develop and refine equity-focused implementation strategies with the community advisory board, comprised of community-based organization members, African Methodist Episcopal Zion Church networks, clinicians, and community health workers (CHWs). In phase 3, the investigators will use a Hybrid Type 1 effectiveness/implementation design with a pragmatic randomized controlled trial with MBTI and a waitlist control in Black women with insomnia. Specialists will assess and address social needs of Black women, and registered nurses will deliver the online MBTI intervention in the community settings. The focus of this registration is phase 3.
The study will contribute to equity-focused implementation science and policy decisions by providing multi-level implementation determinants, equity-relevant metrics, and contextual factors through community-engaged research and evaluation of the outcomes.
Interventions
- Behavioral Mindfulness-based therapy for insomnia (MBTI)
MBTI will be administered in 6 weekly sessions. Session 1 consists of introductions and an overview. Subsequent sessions consist of mindfulness concepts/practice and behavioral strategies for sleep. Each session will begin with guided formal meditation followed by discussion. Mindfulness practice (at home) expectations are 30-45 minutes of meditation/day at least 5 days during the period of the intervention, followed by 20 minutes/day until the final follow-up assessment (at 12 weeks). Mindfulne
Primary outcome measures
- Change in Insomnia Severity [Time frame: baseline, week 6 and week 12]
- Change in Perceived Stress [Time frame: baseline, week 6 and week 12]
- Acceptability of Intervention (AIM) [Time frame: week 6 and week 12]
- Feasibility of Intervention (FIM) [Time frame: week 6 and week 12]
- Treatment Fidelity [Time frame: Weeks 1-6 intervention training sessions]
Eligibility 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.
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Quadruple blind
- Primary purpose
- Supportive care
Study locations
United States · 2 centers
- Yale School of Nursing — New Haven
- Yale School of Nursing Biobehavioral Lab — West Haven
Publications
- Nam S, Tong G, Iennaco J, Humphries D, Ordway M, Lee M, Thompson S, Seguinot M, Morales F, Harriot K, Paris N, Bryant KA, Weidner K, Edwards T, Whittemore R. Protocol for a hybrid type 1 effectiveness-implementation study of mindfulness-based therapy for insomnia in Black women. Contemp Clin Trials. 2026 Jan;160:108166. doi: 10.1016/j.cct.2025.108166. Epub 2025 Nov 25. PMID 41308952
Identifiers
NCT: NCT06348082 · 2000036068 · 1R18HS029812-01