Project Women's Insomnia Sleep Health Equity Study (WISHES)
Project WISHES
Implementing Mindfulness Practice to Advance Sleep Health Equity Among Black Women
2 other identifiers
interventional
340
1 country
2
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable
Started Jan 2026
Typical duration for not_applicable
2 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
February 7, 2024
CompletedFirst Posted
Study publicly available on registry
April 4, 2024
CompletedStudy Start
First participant enrolled
January 6, 2026
CompletedPrimary Completion
Last participant's last visit for primary outcome
July 1, 2028
ExpectedStudy Completion
Last participant's last visit for all outcomes
August 31, 2028
February 19, 2026
February 1, 2026
2.5 years
February 7, 2024
February 18, 2026
Conditions
Outcome Measures
Primary Outcomes (5)
Change in Insomnia Severity
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
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)
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)
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
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
Study Arms (2)
MBTI
EXPERIMENTALParticipants randomized to MBTI group.
Control
NO INTERVENTIONParticipants randomized to waitlist control group.
Interventions
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.
Eligibility Criteria
You may qualify if:
- 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.
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Yale Universitylead
- Department of Health and Human Servicescollaborator
Study Sites (2)
Yale School of Nursing
New Haven, Connecticut, 06477, United States
Yale School of Nursing Biobehavioral Lab
West Haven, Connecticut, 06516, United States
Related Publications (1)
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: 41308952DERIVED
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Soohyun Nam, PhD, APRN, ANP-BC, FAHA, FAAN
Yale University School of Nursing
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- QUADRUPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- SUPPORTIVE CARE
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
February 7, 2024
First Posted
April 4, 2024
Study Start
January 6, 2026
Primary Completion (Estimated)
July 1, 2028
Study Completion (Estimated)
August 31, 2028
Last Updated
February 19, 2026
Record last verified: 2026-02
Data Sharing
- IPD Sharing
- Will share
- Shared Documents
- STUDY PROTOCOL
- Time Frame
- Data will be available as soon as the trial ends and until 6 years after the completion of the trial
- 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.
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.