Clinical trial NCT07009795: Rise & Renew: Supporting Well-Being in Black Women After the Loss of a Loved One
Official title: Rise & Renew (Remembering, Expressing, Navigating, Embracing, Witnessing): Enhancing Well-being Among Black Women Who've Experienced a First-order Bereavement Event
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Bereavement
Grief
Psychological Distress
Well Being
Keywords: Bereavement
Faith-Based Support
Community-Based Intervention
Wellness
African American Women
Spirituality
Psychosocial Support Systems
Mental Health Intervention
Holistic Healing
Lead sponsor: Haley Evaluation & Research Services
Sponsor class: INDUSTRY
Collaborators: name: The Good Stewards Partnership
First posted: 2025-06-08
Enrollment: 40
Sex: FEMALE
Minimum age (years): 40
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Participants are randomly assigned to one of two different groups:

* Immediate Virtual Group Support: Starts the 10-week virtual program within 10 days of completing the retreat.
* Delayed Virtual Group Support: Delays the start of the 10-week virtual program by 10 weeks.

These two groups run in parallel, with both participating in the wellness retreat weekend, followed by different timelines for receiving the 10-week virtual support group part of the intervention.
Primary purpose: SUPPORTIVE_CARE

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.

Eligibility criteria: Inclusion Criteria:

* Self-identifies as a Black or African American woman
* Aged 40 years or older at the time of enrollment
* Has experienced the death of a spouse, parent, or child (first-order bereavement)
* Resides 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, or West Virginia
* Has access to a reliable internet connection and a device capable of running Zoom
* Is able to attend a 2-day in-person retreat in the Stone Mountain, GA area
* Is able and willing to participate in 10 weekly virtual group sessions
* Provides informed consent to participate in the study
* Agrees to complete pre- and post-intervention surveys

Exclusion Criteria:

* Has not experienced the death of a spouse, parent, or child
* Under the age of 40 at the time of enrollment
* Does not reside in the U.S. South Region
* Unable to attend the in-person retreat in Stone Mountain, GA
* Unwilling or unable to participate in weekly Zoom sessions
* Does not have access to the necessary technology for virtual sessions
* Does not provide informed consent
* Currently receiving intensive psychotherapy or psychiatric treatment that would conflict with participation
* Any condition or circumstance that, in the opinion of the investigators, may compromise the participant's ability to safely engage in the group setting

Primary outcomes:
measure: Feasibility of Intervention Measure (FIM)
timeFrame: From baseline to the end of the 10-week support group intervention
measure: Acceptability of Intervention Measure (AIM)
timeFrame: FroFrom baseline to the end of the 10-week support group intervention
measure: Intervention Appropriateness Measure (IAM)
timeFrame: From baseline to the end of the 10-week support group intervention
Secondary outcomes:
measure: Change from Baseline in Coping Strategies Measured by the Brief COPE at Week 10
timeFrame: From baseline (Week 0) to Week 10 (end of intervention)
measure: Change from Baseline in Religious Coping Strategies Measured by the Brief RCOPE at Week 10
timeFrame: From baseline (Week 0) to Week 10
measure: Change from Baseline in Depression Symptoms Measured by the PHQ-8 at Week 10
timeFrame: From baseline (Week 0) to Week 10
measure: Change from Baseline in Perceived Social Support Measured by the MSPSS at Week 10
timeFrame: From baseline (Week 0) to Week 10
measure: Change from Baseline in Posttraumatic Growth Measured by the PTGI at Week 10
timeFrame: From baseline (Week 0) to Week 10
measure: Change from Baseline in Perceived Social Support Measured by the SCSSS at Week 10
timeFrame: From baseline (Week 0) to Week 10
Other outcomes:
measure: Change from Baseline in Group Cohesion Measured by the Group Climate Questionnaire (Sista Circle Edition) at Week 10
timeFrame: From baseline (Week 0) to Week 10
measure: Change from Baseline in Afrocultural Communal Orientation Measured by the Revised Communalism Scale at Week 10
timeFrame: From baseline (Week 0) to Week 10
measure: Change from Baseline in Whole Person Health Measured by the Whole Person Health Index (WPHI) at Week 10
timeFrame: From baseline (Week 0) to Week 10
Locations:
city: Lithonia
country: United States
facility: Serenity Haven
state: Georgia
Study officials:
References:
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citation: Arnold KT, Mandell DS, Hankerson SH. Implementing a Grief Support Program in a Black Church to Support the Mental Health Needs of People in Bereavement. Psychiatr Serv. 2025 Jan 1;76(1):105. doi: 10.1176/appi.ps.20240259. Epub 2024 Oct 23. No abstract available.