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

February 18, 2026 updated by: Yale University

Implementing Mindfulness Practice to Advance Sleep Health Equity Among Black Women

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

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

Enrollment (Estimated)

340

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • United States
    • Connecticut
      • New Haven, Connecticut, United States, 06477
      • West Haven, Connecticut, United States, 06516
        • Recruiting
        • Yale School of Nursing Biobehavioral Lab
        • Contact:
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Supportive Care
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: MBTI
Participants randomized to MBTI group.
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). 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.
No Intervention: Control
Participants randomized to waitlist control group.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
baseline, week 6 and week 12
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.
baseline, week 6 and week 12
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.
week 6 and week 12
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.
week 6 and week 12
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.
Weeks 1-6 intervention training sessions

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Yale University

Collaborators

Department of Health and Human Services

Investigators

  • Principal Investigator: Soohyun Nam, PhD, APRN, ANP-BC, FAHA, FAAN, Yale University School of Nursing

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

January 6, 2026

Primary Completion (Estimated)

July 1, 2028

Study Completion (Estimated)

August 31, 2028

Study Registration Dates

First Submitted

February 7, 2024

First Submitted That Met QC Criteria

March 28, 2024

First Posted (Actual)

April 4, 2024

Study Record Updates

Last Update Posted (Actual)

February 19, 2026

Last Update Submitted That Met QC Criteria

February 18, 2026

Last Verified

February 1, 2026

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2000036068
  • 1R18HS029812-01 (U.S. AHRQ Grant/Contract)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

Investigators will publish a number of manuscripts related to the methods, implementation process, and the trial analyses planned for the project. These will be published in a timely fashion as soon as data can be shared. Investigators plan to widely disseminate the findings of this project to the scientific community by presenting the findings at numerous scientific meetings and will make these slide presentations available to the research community. Investigators will also disseminate our scientific products in lay formats (e.g., research briefs, infographics) through our Expert Advisory Board and community partners. Investigators plan to make available the cleaned and completely de-identified datasets and PDF versions of our research forms and research protocol.

IPD Sharing Time Frame

Data will be available as soon as the trial ends and until 6 years after the completion of the trial

IPD Sharing Access Criteria

A data sharing agreement will be required for release of any data. Individuals requesting a copy of study data will need to submit a detailed research plan that includes the purpose of the proposed research, the variables required, the duration of the analysis phase, IRB approval, investigator training in human subjects and other approvals specific to the individual datasets. They will also be required to submit a Data Protection Plan or Institutional Privacy Policy, describing the computing environment in which data will be managed and analyzed and how physical access to computing equipment will be controlled. Data will only be released once all IRB approvals and Human Subjects concerns have been addressed. Data collection instruments, codebooks, and other data documentation will be made available in conjunction with this dataset in a standard format that is readable across a variety of applications and operating system platforms.

IPD Sharing Supporting Information Type

  • STUDY_PROTOCOL

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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