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

Part of paid clinical trials in New Haven, Connecticut.

Sponsor
Yale University
Study ID
NCT06348082
Status
Recruiting
Apply to this trial

Conditions

  • Cardiometabolic Health
  • Insomnia
  • Sleep Health

Eligibility Criteria

Sex
FEMALE
Age
18 Years - 70 Years
Healthy Volunteers
Not accepted

Interventions

  • 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.

Study Details

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.

Key Dates

Start date
Jan 6, 2026
Status verified
Feb 2026
Primary completion
Jul 1, 2028
Completion
Aug 31, 2028

Study Design

Enrollment
340 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE

Arms

  • Experimental: MBTI
    Participants randomized to MBTI group.
  • No Intervention: Control
    Participants randomized to waitlist control group.

Primary Outcome Measure

Change in Insomnia Severity [ Time Frame: baseline, week 6 and week 12 ]

Central Contacts

Locations (2)

FacilityCityStateZIPSite coordinators
Yale School of NursingNew HavenConnecticut06477
Mary Grund, BS
[email protected]
203.645.7647
Soohyun Nam, PhD, APRN, ANP-BC, FAHA, FAAN
[email protected]
Yale School of Nursing Biobehavioral LabWest HavenConnecticut06516
Mary Grund, BS
[email protected]
203.737.1604
Soohyun Nam, PhD, APRN, ANP-BC, FAHA, FAAN
[email protected]

Find similar trials in New Haven, CT

By condition
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By specialty
Mental healthSleep medicine
By research site
Yale School of Nursing· New Haven, CTYale School of Nursing Biobehavioral Lab· West Haven, CT

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