Project Women's Insomnia Sleep Health Equity Study (WISHES)
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexFemale
Age18-70
SponsorYale University
About this trial
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
Qualifiers
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.
Disqualifiers
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.
Trial design
Treatments tested in this trial
- Mindfulness-based therapy for insomnia (MBTI)
Treatment groups
340 Participants
are divided into 2 treatment groupsSponsors and collaborators
Yale University
Lead sponsor
Department of Health and Human Services
Collaborator
Source ClinicalTrials.gov