Ignite Creation Date:
2025-12-24 @ 2:03 PM
Ignite Modification Date:
2026-01-10 @ 7:05 PM
Study NCT ID:
NCT07009795
Status:
RECRUITING
Last Update Posted:
2025-06-08
First Post:
2025-05-20
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Rise & Renew: Supporting Well-Being in Black Women After the Loss of a Loved One
Sponsor:
Lillian Haley, PhD
Organization:
Study Overview
Official Title:
Rise & Renew (Remembering, Expressing, Navigating, Embracing, Witnessing): Enhancing Well-being Among Black Women Who've Experienced a First-order Bereavement Event
Status:
RECRUITING
Status Verified Date:
2025-05
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:
RENEW
Brief Summary:
This study is testing a new grief support program called Rise \& Renew (Remembering, Expressing, Navigating, Embracing, Witnessing) designed for Black women ages 40 and older who have experienced the loss of a close loved one, such as a spouse or significant other, parent, or child (including pregnancies). The program includes a weekend wellness retreat followed by 10 weeks of online group support. Participants will be randomly assigned to start weekly virtual sessions right away or after a 10-week delay. The study will help the investigators learn whether the program is helpful, easy to take part in, and meaningful for those who attend. The investigators believe that a culturally tailored program that focuses on healing, wellness, and community will improve emotional health, spiritual well-being, and resilience during the grief process.
Detailed Description:
Rise \& Renew (Remembering, Expressing, Navigating, Embracing, Witnessing) is a pilot randomized controlled trial (RCT) using a waitlist control design to evaluate the feasibility, acceptability, and preliminary outcomes of a culturally responsive hybrid grief support program for Black women aged 40 and older who have experienced the death of a spouse/significant other, parent, or child (including pregnancies).
This study addresses critical gaps in bereavement support for Black women, who often face intersecting emotional, cultural, and spiritual needs. The Rise \& Renew program is rooted in wellness practices, spiritual care, and culturally grounded healing rituals.
Study Design
After completing the baseline assessment, participants will be randomly assigned (1:1) to one of two groups using a computer-generated randomization sequence:
* Group A (Intervention Group): Will participate in an in-person weekend retreat and begin the 12-week Rise \& Renew virtual support program immediately.
* Group B (Waitlist Control Group): Will attend the same in-person retreat but will delay participation in the 12-week virtual program for 12 weeks.
This staggered model allows researchers to examine short-term changes in well-being and grief outcomes while providing all participants access to the full intervention.
Intervention Description
Rise \& Renew is a 12-week hybrid grief support program designed to affirm the cultural identity, spirituality, and healing traditions of Black women. The program consists of:
* One In-Person Weekend Retreat: Focused on wellness, healing rituals, community building, and expressive arts.
* 10 Weekly Virtual Support Sessions: Co-facilitated by a professional with group facilitation expertise and a Black faith leader. Session themes include:
* Grief and emotional healing
* Spiritual and personal growth
* Financial empowerment
* Self-care and wellness
* Building social support networks
Recruitment and Eligibility The study is open to self-identified Black women aged 40 and older, living in the U.S. South Region, including Alabama, Arkansas, Delaware, District of Columbia, Florida, Georgia, Kentucky, Louisiana, Maryland, Mississippi, North Carolina, Oklahoma, South Carolina, Tennessee, Texas, Virginia, and West Virginia. Recruitment will be conducted via digital outreach, including phone calls, text messages, and a study webpage.
Data Collection
This study uses a mixed-methods approach to collect both quantitative and qualitative data:
* Needs Assessment Survey: Conducted before the retreat to gather information on participants' unique needs and expectations, allowing facilitators to tailor the program accordingly.
* Baseline: Participants will complete a pre-intervention survey in Qualtrics assessing grief, stress, depression, physical wellness (including self-reported blood pressure and weight), social support, and financial resilience.
* Post-Intervention: Surveys and optional focus groups/interviews will assess perceived benefits, changes in well-being, and overall program satisfaction.
All participants will be invited to join Part 2 (10-week support group) after the retreat, regardless of initial group assignment. Participation is voluntary, and no compensation will be provided.
This study addresses critical gaps in bereavement support for Black women, who often face intersecting emotional, cultural, and spiritual needs. The Rise \& Renew program is rooted in wellness practices, spiritual care, and culturally grounded healing rituals.
Study Design
After completing the baseline assessment, participants will be randomly assigned (1:1) to one of two groups using a computer-generated randomization sequence:
* Group A (Intervention Group): Will participate in an in-person weekend retreat and begin the 12-week Rise \& Renew virtual support program immediately.
* Group B (Waitlist Control Group): Will attend the same in-person retreat but will delay participation in the 12-week virtual program for 12 weeks.
This staggered model allows researchers to examine short-term changes in well-being and grief outcomes while providing all participants access to the full intervention.
Intervention Description
Rise \& Renew is a 12-week hybrid grief support program designed to affirm the cultural identity, spirituality, and healing traditions of Black women. The program consists of:
* One In-Person Weekend Retreat: Focused on wellness, healing rituals, community building, and expressive arts.
* 10 Weekly Virtual Support Sessions: Co-facilitated by a professional with group facilitation expertise and a Black faith leader. Session themes include:
* Grief and emotional healing
* Spiritual and personal growth
* Financial empowerment
* Self-care and wellness
* Building social support networks
Recruitment and Eligibility The study is open to self-identified Black women aged 40 and older, living in the U.S. South Region, including Alabama, Arkansas, Delaware, District of Columbia, Florida, Georgia, Kentucky, Louisiana, Maryland, Mississippi, North Carolina, Oklahoma, South Carolina, Tennessee, Texas, Virginia, and West Virginia. Recruitment will be conducted via digital outreach, including phone calls, text messages, and a study webpage.
Data Collection
This study uses a mixed-methods approach to collect both quantitative and qualitative data:
* Needs Assessment Survey: Conducted before the retreat to gather information on participants' unique needs and expectations, allowing facilitators to tailor the program accordingly.
* Baseline: Participants will complete a pre-intervention survey in Qualtrics assessing grief, stress, depression, physical wellness (including self-reported blood pressure and weight), social support, and financial resilience.
* Post-Intervention: Surveys and optional focus groups/interviews will assess perceived benefits, changes in well-being, and overall program satisfaction.
All participants will be invited to join Part 2 (10-week support group) after the retreat, regardless of initial group assignment. Participation is voluntary, and no compensation will be provided.
Study Oversight
Has Oversight DMC:
False
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?: