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NCT Number: NCT06348082

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

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.

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Key information

Conditions

Insomnia Cardiometabolic Health Dyssomnias Mental Disorders Nervous System Diseases Sleep Disorders, Intrinsic Sleep Health Sleep Initiation and Maintenance Disorders Sleep Wake Disorders

Age range

18 year–70 year

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

Yale School of Nursing, New Haven, Connecticut, United States

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About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Mindfulness-based therapy for insomnia (MBTI)

Behavioral

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). Mindfulness concepts: Overview of Mindfulness, Mindfulness of the Body, Obstacles to Mindfulness, Working with Difficult Emotions, Cultivating Positive Emotions, Working with Difficult Thoughts, Mindful Interactions.

Primary outcomes

  1. Change in Insomnia Severity

    Time frame: baseline, week 6 and week 12

    Change in Insomnia severity or remission will be assessed using the Insomnia Severity Index (ISI). The ISI is a 7 item survey used to determine insomnia severity. Total score range from 0-28 with cutoffs as follows: no insomnia (0-7), sub-threshold insomnia (8-14), moderate insomnia (15-21), and severe insomnia (22-28). Response to the MBTI on the ISI will be defined as a meaningful change of 7 or more points from baseline, or remission as reduction to a score less than 8.

  2. Change in Perceived Stress

    Time frame: baseline, week 6 and week 12

    Change will be assessed using the Perceived Stress Scale (PSS -10) Total score range from 0-40 with cutoffs as follows: low perceived stress (0-13); moderate perceived stress (14-26); high perceived stress (27-40). Response to the MBTI on the PSS will be defined as a meaningful change of 5 or more points from baseline, or remission as reduction to a score less than 13.

  3. Acceptability of Intervention (AIM)

    Time frame: week 6 and week 12

    Acceptability of the implementation strategy will be assessed using the Acceptability of Intervention measure (AIM). It has 4-items scored on a 5-point Likert scale summed to achieve a total score. Total score range of 0-20. Higher scores indicate more acceptability.

  4. Feasibility of Intervention (FIM)

    Time frame: week 6 and week 12

    Feasibility of the implementation strategy will be assessed using the Acceptability of Intervention measure (FIM). It has 4-items scored on a 5-point Likert scale summed to achieve a total score. Total score range of 0-20. Higher scores indicate higher likelihood of feasibility.

  5. Treatment Fidelity

    Time frame: Weeks 1-6 intervention training sessions

    Fidelity to the MBTI intervention will be scored using The Mindfulness-Based Relapse Prevention Adherence and Competence Scale (MBRP-AC), a treatment fidelity checklist tool for mindfulness interventions. Specifically, staff trained to observe key components of intervention delivery will complete a checklist of items that correspond to each session (n=8) to evaluate the fidelity to the intervention protocol. Summary scores will reflect the higher the percentage of key components checked off, the higher the fidelity to the treatment intervention protocol.

Study contacts

Contact information is provided by the study sponsor or research team.

Siobhan Thompson, MPH

CONTACT

[email protected]

203.645.7647

Soohyun Nam, phD

CONTACT

[email protected]

203.737.2822

Sponsors and collaborators

Lead sponsor

Yale University

Other

Collaborators

  • Department of Health and Human Services

Registry information

Official study title

Implementing Mindfulness Practice to Advance Sleep Health Equity Among Black Women

Acronym: Project WISHES

Important dates

Study start
2026
Primary completion
2028
Study completion
2028
First posted
Apr 4, 2024
Registry last updated
Feb 19, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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