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

Last updated: February 18, 2026
Sponsor: Yale University
Overall Status: Active - Recruiting

Phase

N/A

Condition

Insomnia

Treatment

Mindfulness-based therapy for insomnia (MBTI)

Clinical Study ID

NCT06348082
2000036068
1R18HS029812-01
  • Ages 18-70
  • Female

Study 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.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  • self-identified Black women

  • English speaking

  • meet ICSD3 diagnostic criteria for insomnia disorders, defined as difficultyinitiating or maintaining sleep that occurs despite adequate opportunity to sleepwith at least one associated daytime impairment symptom (ISI > 7)

  • additional quantitative insomnia criteria based on research recommendations and thenew ICSD3: (a) severity of sleep onset latency or wake time after sleep onset of ≥31min, (b) occurring ≥3 nights a week, and (c) for ≥ 3 months.

Exclusion

Exclusion Criteria:

  • Psychosis or unstable/significant depression, anxiety, or substance abuse underactive care (more than 1 monthly mental healthcare visit or requiring more than 1psychotropic medicine daily)

  • significant current practice of any form of meditation (>15min per day)

  • obstructive sleep apnea (OSA), restless legs syndrome (RLS), or circadian rhythmrelated condition (shift worker, use of medication that influence circadian rhythm,e.g., Parkinson's disease)

  • active or terminal cancer.

Study Design

Total Participants: 340
Treatment Group(s): 1
Primary Treatment: Mindfulness-based therapy for insomnia (MBTI)
Phase:
Study Start date:
January 06, 2026
Estimated Completion Date:
August 31, 2028

Study 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.

Connect with a study center

  • Yale School of Nursing Biobehavioral Lab

    West Haven, Connecticut 06516
    United States

    Site Not Available

  • Yale School of Nursing

    New Haven 4839366, Connecticut 4831725 06477
    United States

    Active - Recruiting

  • Yale School of Nursing Biobehavioral Lab

    West Haven 4845419, Connecticut 4831725 06516
    United States

    Active - Recruiting

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