NCT07009795

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.

Trial Health

75
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
40

participants targeted

Target at P25-P50 for not_applicable

Timeline
0mo left

Started May 2025

Geographic Reach
1 country

1 active site

Status
active not recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress97%
May 2025May 2026

First Submitted

Initial submission to the registry

May 20, 2025

Completed
Same day until next milestone

Study Start

First participant enrolled

May 20, 2025

Completed
19 days until next milestone

First Posted

Study publicly available on registry

June 8, 2025

Completed
12 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 19, 2026

Expected
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

May 19, 2026

Last Updated

December 30, 2025

Status Verified

December 1, 2025

Enrollment Period

12 months

First QC Date

May 20, 2025

Last Update Submit

December 22, 2025

Conditions

Keywords

BereavementFaith-Based SupportCommunity-Based InterventionWellnessAfrican American WomenSpiritualityPsychosocial Support SystemsMental Health InterventionHolistic Healing

Outcome Measures

Primary Outcomes (3)

  • Feasibility of Intervention Measure (FIM)

    The 4-item Feasibility of Intervention Measure was developed for evaluating the success of feasibility, demonstrating encouraging psychometric properties. The items that are scored on a scale of 0 to 4, where 0 indicates "completely disagree," and 4 indicates "completely agree". Thus, the range for each scale extends from 0 - 16, with higher scores indicating higher feasibility.

    From baseline to the end of the 10-week support group intervention

  • Acceptability of Intervention Measure (AIM)

    The 4-item Acceptability of Intervention Measure was developed for evaluating the success of acceptability, demonstrating encouraging psychometric properties. The items are scored on a scale of 0 to 4, where 0 indicates "completely disagree," and 4 indicates "completely agree". Thus, the range for each scale extends from 0 - 16, with higher scores indicating higher acceptability.

    FroFrom baseline to the end of the 10-week support group intervention

  • Intervention Appropriateness Measure (IAM)

    The 4-item Acceptability of Intervention Measure was developed for measuring the perceived fit, relevance, or compatibility of the innovation or evidence-based practice for a given practice setting, provider, or consumer, and/or perceived fit of the innovation to address a particular issue or problem. The items are scored on a scale of 0 to 4, where 0 indicates "completely disagree," and 4 indicates "completely agree". Thus, the range for each scale extends from 0 - 16, with higher scores indicating higher appropriateness.

    From baseline to the end of the 10-week support group intervention

Secondary Outcomes (6)

  • Change from Baseline in Coping Strategies Measured by the Brief COPE at Week 10

    From baseline (Week 0) to Week 10 (end of intervention)

  • Change from Baseline in Religious Coping Strategies Measured by the Brief RCOPE at Week 10

    From baseline (Week 0) to Week 10

  • Change from Baseline in Depression Symptoms Measured by the PHQ-8 at Week 10

    From baseline (Week 0) to Week 10

  • Change from Baseline in Perceived Social Support Measured by the MSPSS at Week 10

    From baseline (Week 0) to Week 10

  • Change from Baseline in Posttraumatic Growth Measured by the PTGI at Week 10

    From baseline (Week 0) to Week 10

  • +1 more secondary outcomes

Other Outcomes (3)

  • Change from Baseline in Group Cohesion Measured by the Group Climate Questionnaire (Sista Circle Edition) at Week 10

    From baseline (Week 0) to Week 10

  • Change from Baseline in Afrocultural Communal Orientation Measured by the Revised Communalism Scale at Week 10

    From baseline (Week 0) to Week 10

  • Change from Baseline in Whole Person Health Measured by the Whole Person Health Index (WPHI) at Week 10

    From baseline (Week 0) to Week 10

Study Arms (2)

Immediate Virtual Group Support

EXPERIMENTAL

Receives the in-person wellness retreat and begins the 10-week virtual support phase the following weekend.

Behavioral: Rise & Renew Hybrid Grief Support Program

Delayed Virtual Group Support

NO INTERVENTION

Attends the same in-person wellness retreat but does not begin the 10-week virtual support program until after a 10-week delay.

Interventions

The Rise \& Renew Hybrid Grief Support Program is a culturally responsive, multi-component behavioral intervention designed specifically for Black women aged 40 and older who have experienced the loss of a spouse, parent, or child. It integrates wellness practices, grief support, spiritual care, and community healing in a hybrid format that includes both an in-person and virtual component. This intervention is distinguished by its cultural tailoring for middle-aged and older Black women, co-facilitation by both a trained facilitator and a faith-based leader, and its combination of expressive arts, spiritual guidance, and practical wellness strategies delivered in a hybrid format. It addresses grief holistically through emotional, physical, spiritual, and social dimensions, and emphasizes culturally relevant healing practices often overlooked in conventional grief programs.

Immediate Virtual Group Support

Eligibility Criteria

Age40 Years+
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Serenity Haven

Lithonia, Georgia, 30058, United States

Location

Related Publications (6)

  • Jones, M. K., Davis, S. M., & Gaskin-Cole, G. (2023). An integrative review of sistah circles in empirical research. Psychology of Women Quarterly, 47(2), 159-179.

    BACKGROUND
  • Neal-Barnett A, Stadulis R, Murray M, Payne MR, Thomas A, Salley BB. Sister Circles as a Culturally Relevant Intervention for Anxious African American Women. Clin Psychol (New York). 2011 Sep;18(3):266-273. doi: 10.1111/j.1468-2850.2011.01258.x.

    PMID: 22081747BACKGROUND
  • Jones, M. K., Gaskin-Cole, G., & Reynolds, A. (2023). Masks off: A community-based psychoeducational group intervention with Black women. The Journal for Specialists in Group Work, 48(3), 212-228.

    BACKGROUND
  • DiGuiseppi G, Rodriguez A, Qureshi N, Zeng C, Coulter ID, Hays RD, Herman PM, Edelen MO. Measuring Whole Person Health: A Scoping Review. J Integr Complement Med. 2025 Aug;31(8):684-704. doi: 10.1089/jicm.2024.0817. Epub 2025 Apr 3.

    PMID: 40180567BACKGROUND
  • Brown M, Glendenning A, Hoon AE, John A. Effectiveness of Web-Delivered Acceptance and Commitment Therapy in Relation to Mental Health and Well-Being: A Systematic Review and Meta-Analysis. J Med Internet Res. 2016 Aug 24;18(8):e221. doi: 10.2196/jmir.6200.

    PMID: 27558740BACKGROUND
  • 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.

    PMID: 39439280BACKGROUND

MeSH Terms

Interventions

Risedronic Acid

Intervention Hierarchy (Ancestors)

DiphosphonatesOrganophosphonatesOrganophosphorus CompoundsOrganic ChemicalsPyridinesHeterocyclic Compounds, 1-RingHeterocyclic Compounds

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
SUPPORTIVE CARE
Intervention Model
PARALLEL
Model Details: 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.
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

May 20, 2025

First Posted

June 8, 2025

Study Start

May 20, 2025

Primary Completion (Estimated)

May 19, 2026

Study Completion (Estimated)

May 19, 2026

Last Updated

December 30, 2025

Record last verified: 2025-12

Data Sharing

IPD Sharing
Will not share

At this time, individual participant data (IPD) will not be shared due to the sensitive nature of grief-related experiences and the small sample size, which increases the risk of deductive disclosure even after de-identification. The study population-middle-aged Black women who have experienced the loss of a close loved one-represents a highly specific and vulnerable group. To protect participant confidentiality and respect the culturally sensitive context of the study, data sharing is not planned.

Locations