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

Not Applicable

Not yet recruiting

• Conditions: Cardiometabolic Health; Insomnia; Sleep Health
• Interventions: Behavioral: Mindfulness-based therapy for insomnia (MBTI)

• Registration Number: NCT06348082
• Lead 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.

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 Timeline

• Study First Submitted: 2024-02-07
• Study First Submitted QC: 2024-03-28
• Study First Posted: 2024-04-04
• Status Verified: 2025-03
• Last Update Submitted: 2025-03-27
• Last Update Posted: 2025-04-02
• Study Start: 2025-09
• Primary Completion: 2028-07
• Study Completion: 2028-07

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: Female
• Target Recruitment: 340

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
MBTI	Mindfulness-based therapy for insomnia (MBTI)	Participants randomized to MBTI group.

Primary Outcome Measures

Name	Time	Method
Change in Insomnia Severity	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.
Change in Perceived Stress	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.
Acceptability of Intervention (AIM)	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.
Feasibility of Intervention (FIM)	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.
Treatment Fidelity	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.

Trial Locations

Locations (1)

Yale School of Nursing Biobehavioral Lab; 🇺🇸 West Haven, Connecticut, United States