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

NCT ID: NCT06348082

Last Updated: 2025-04-02

Basic Information

• Recruitment Status: NOT_YET_RECRUITING
• Clinical Phase: NA
• Total Enrollment: 340 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2025-09-30
• Study Completion Date: 2028-07-31

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.

Conditions

Insomnia; Sleep Health; Cardiometabolic Health

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: SUPPORTIVE_CARE
• Blinding Strategy: QUADRUPLE

Study Groups

MBTI

Participants randomized to MBTI group.

Group Type: EXPERIMENTAL

Mindfulness-based therapy for insomnia (MBTI)

Intervention Type: 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.

Control

Participants randomized to waitlist control group.

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

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.

Intervention Type: BEHAVIORAL

Eligibility Criteria

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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 70 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: No

Sponsors

Department of Health and Human Services

FED

Sponsor Role: collaborator

Yale University

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Soohyun Nam, PhD, APRN, ANP-BC, FAHA, FAAN

Role: PRINCIPAL_INVESTIGATOR

Yale University School of Nursing

Locations

Yale School of Nursing Biobehavioral Lab

West Haven, Connecticut, United States

Countries

United States

Central Contacts

Siobhan Thompson, MPH

Role: CONTACT

siobhan.thompson@yale.edu

203.785.4222

Other Identifiers

1R18HS029812-01

Identifier Type: AHRQ

Identifier Source: secondary_id

View Link

2000036068

Identifier Type: -

Identifier Source: org_study_id