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

Yale University logo

Yale University

Status

Begins enrollment in 9 months

Conditions

Cardiometabolic Health
Insomnia
Sleep Health

Treatments

Behavioral: Mindfulness-based therapy for insomnia (MBTI)

Study type

Interventional

Funder types

Other
Other U.S. Federal agency

Identifiers

NCT06348082
1R18HS029812-01 (U.S. AHRQ Grant/Contract)
2000036068

Details and patient eligibility

About

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.

Full 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.

Enrollment

340 estimated patients

Sex

Female

Ages

18 to 70 years old

Volunteers

No Healthy Volunteers

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.

Trial design

Primary purpose

Supportive Care

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Quadruple Blind

340 participants in 2 patient groups

MBTI
Experimental group
Description:
Participants randomized to MBTI group.
Treatment:
Behavioral: Mindfulness-based therapy for insomnia (MBTI)
Control
No Intervention group
Description:
Participants randomized to waitlist control group.

Trial contacts and locations

1

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Central trial contact

Siobhan Thompson, MPH

Data sourced from clinicaltrials.gov

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