Ignite Creation Date:
2024-05-06 @ 8:21 PM
Last Modification Date:
2024-10-26 @ 3:25 PM
Study NCT ID:
NCT06348082
Status:
NOT_YET_RECRUITING
Last Update Posted:
2024-04-05
First Post:
2024-02-07
Brief Title:
Project Womens Insomnia Sleep Health Equity Study WISHES
Sponsor:
Yale University
Organization:
Yale University
Study Overview
Official Title:
Implementing Mindfulness Practice to Advance Sleep Health Equity Among Black Women
Status:
NOT_YET_RECRUITING
Status Verified Date:
2024-04
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
Project WISHES
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 effectivenessimplementation 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
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
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| 1R18HS029812-01 | AHRQ | None | httpsreporternihgovquickSearch1R18HS029812-01 |