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NCT06348082 | NOT YET RECRUITING | Insomnia

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

Yale University

Brief Summary:

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.

Condition or disease

Insomnia

Sleep Health

Cardiometabolic Health

Intervention/treatment

Mindfulness-based therapy for insomnia (MBTI)

Phase

NA

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.

Study Type : INTERVENTIONAL
Estimated Enrollment : 340 participants
Masking : QUADRUPLE
Primary Purpose : SUPPORTIVE_CARE
Official Title : Implementing Mindfulness Practice to Advance Sleep Health Equity Among Black Women
Actual Study Start Date : 2025-09
Estimated Primary Completion Date : 2028-07
Estimated Study Completion Date : 2028-07

Information not available for Arms and Intervention/treatment

Ages Eligible for Study: 18 Years to 70 Years
Sexes Eligible for Study: FEMALE
Accepts Healthy Volunteers:
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.
Project Women's Insomnia Sleep Health Equity Study (WISHES)

Location Details

NCT06348082

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Locations

Not yet recruiting

United States, Connecticut

Yale School of Nursing Biobehavioral Lab

West Haven, Connecticut, United States, 06516