NCT05902741

The Impact of a Race-Based Stress Reduction Intervention

Recruiting now NA Last updated 9 September 2025

What this trial tests

NA trial testing RiSE in Racism in 300 participants. Currently enrolling.

Timeline

18 October 2023

Primary endpoint
31 January 2028

31 January 2028

Quick facts

Lead sponsor	Loyola University
Phase	NA
Status	Recruiting now
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	single
Primary purpose	prevention
Enrollment	300
Start date	18 October 2023
Primary completion	31 January 2028
Estimated completion	31 January 2028
Sites	1 location across United States

Drugs / interventions tested

• RiSE
• HEP

Conditions studied

• Racism — all drugs for Racism →
• Stress — all drugs for Stress →
• Inflammation — all drugs for Inflammation →

Sponsor

Loyola University

Who can join

Adults 50 to 75, female only, with Racism or Stress. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

The goal of this clinical trial is to learn whether a stress reduction program called Resilience, Stress, and Ethnicity (RiSE) improves well-being, inflammation, and the epigenome in African American (AA) women who have risk factors for heart or metabolic disease.

The main question it aims to answer is whether an intervention that integrates cognitive-behavioral strategies focused on the impact that social stress, such as racism, has on the body, racial identity development, and empowerment.

Participants will placed in one of the two following groups:

* The RiSE program will focus on teaching participants how to reduce their stress levels and will meet online weekly for approximately 2 hours each week for 8 consecutive weeks.
* The Health Education program will include education on how to improve general health and will meet online weekly for approximately 2 hours each week for 8 consecutive weeks.

Participants will provide saliva to measure cytokines and DNA methylation (DNAm), complete questionnaires, and have blood pressure, heart rate, and weight measured at the following clinic visits:

1. Prior to starting the intervention
2. Mid-way through the intervention (Week 4)
3. End of the intervention (Week 8)
4. Six (6) months after the completion of the intervention

Publications & conference data

2 peer-reviewed publications reference this trial (live from Europe PMC):

1. The race-based stress reduction intervention (RiSE) study on African American women in NYC and Chicago: Design and methods for complex genomic analysis.
   Taylor JY, Jones-Patten A, Prescott L, Potts-Thompson S, et al · · 2024 · cited 7× · PMID 38598554 · DOI 10.1371/journal.pone.0295293
2. The Effectiveness of a Race-Based Stress Reduction Intervention on Improving Stress-Related Symptoms and Inflammation in African American Women at Risk for Cardiometabolic Disease: Protocol for Recruitment and Intervention for a Randomized Controlled Trial.
   Saban KL, Joyce C, Nyembwe A, Janusek L, et al · · 2025 · cited 2× · PMID 40250840 · DOI 10.2196/65649