Clinical trial NCT06348082: Project Women's Insomnia Sleep Health Equity Study (WISHES)
Official title: Implementing Mindfulness Practice to Advance Sleep Health Equity Among Black Women
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Insomnia
Sleep Health
Cardiometabolic Health
Lead sponsor: Yale University
Sponsor class: OTHER
Collaborators: name: Department of Health and Human Services
First posted: 2024-04-04
Enrollment: 340
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Hybrid Type 1 effectiveness/implementation study using a pragmatic randomized controlled trial (RCT) with MBTI and a waitlist control. Participants will be randomly assigned by a computer-generated sequence to either the MBTI or waitlist control in a 1:1 ratio using permuted blocks stratified by age (2 strata: ≤50 or postmenopausal age \>51) with random block sizes of 2 or 4 to reduce predictability.
Primary purpose: SUPPORTIVE_CARE

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.

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.

Primary outcomes:
measure: Change in Insomnia Severity
timeFrame: baseline, week 6 and week 12
measure: Change in Perceived Stress
timeFrame: baseline, week 6 and week 12
measure: Acceptability of Intervention (AIM)
timeFrame: week 6 and week 12
measure: Feasibility of Intervention (FIM)
timeFrame: week 6 and week 12
measure: Treatment Fidelity
timeFrame: Weeks 1-6 intervention training sessions
Secondary outcomes:
Other outcomes:
Locations:
city: West Haven
country: United States
facility: Yale School of Nursing Biobehavioral Lab
state: Connecticut
Study officials:
affiliation: Yale University School of Nursing
name: Soohyun Nam, PhD, APRN, ANP-BC, FAHA, FAAN
role: PRINCIPAL_INVESTIGATOR
References: