Project Women's Insomnia Sleep Health Equity Study (WISHES)

Официальное название

Implementing Mindfulness Practice to Advance Sleep Health Equity Among Black Women

Обзор

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.

Подробное описание

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.

Вмешательства

• Поведенческое 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

Первичные конечные точки

• Change in Insomnia Severity [Срок оценки: baseline, week 6 and week 12]
• Change in Perceived Stress [Срок оценки: baseline, week 6 and week 12]
• Acceptability of Intervention (AIM) [Срок оценки: week 6 and week 12]
• Feasibility of Intervention (FIM) [Срок оценки: week 6 and week 12]
• Treatment Fidelity [Срок оценки: Weeks 1-6 intervention training sessions]

Критерии участия

Критерии включения

• 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.

Критерии исключения

• 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.

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Рандомизированное

Модель

Параллельные группы

Маскирование

Четверное слепое

Основная цель

Поддерживающая терапия

Центры проведения

США · 2 центра

• Yale School of Nursing — New Haven
• Yale School of Nursing Biobehavioral Lab — West Haven

Публикации

• 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

Идентификаторы

NCT: NCT06348082 · 2000036068 · 1R18HS029812-01

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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