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Recruiting NCT06348082

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

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Plain-language summary for patients

Trial Parameters

Condition Insomnia
Sponsor Yale University
Study Type INTERVENTIONAL
Phase N/A
Enrollment 340
Sex FEMALE
Min Age 18 Years
Max Age 70 Years
Start Date 2026-01-06
Completion 2028-07-01
Interventions
Mindfulness-based therapy for insomnia (MBTI)

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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.

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'

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