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.

Abstract

Background: In recent years, the prevalence of cardiometabolic disease (CMD) in African American women has risen; the risk also increases with age, in comparison to men. Evidence demonstrates that stressful life events, including experiences of racism and perceived discrimination, contribute substantially to inflammatory diseases, such as CMD. Despite this evidence, few evidence-based interventions are available to assist individuals from minoritized communities in coping with the chronic stress related to their racial or ethnic identity.

Objective: Our proposed randomized controlled trial will test a novel, race-based intervention tailored to African American women, called Resilience, Stress, and Ethnicity (RiSE).

Methods: In this randomized controlled trial, we will randomize participants 1:1 to the 8-week, group-based RiSE program (intervention) or a health education program (active control group). Both programs will consist of synchronous classes on Zoom and will be led by experts. The primary end point will be stress at 6 months after the intervention, and the efficacy of RiSE will be evaluated for improving stress-related symptoms (current perceived stress, depressive symptoms, fatigue, and sleep disturbance), improving coping strategies, and reducing inflammatory burden in African American women at risk for CMD. Validated survey measures and inflammatory biomarkers will be assessed at baseline, midintervention, intervention completion, and 6 months after the intervention, and differences over time by intervention will be evaluated using mixed effects models.

Results: This study was funded by the National Institute on Aging on March 30, 2023, with recruitment and enrollment beginning in October 2023. The study is underway, with 120 participants enrolled as of March 2025.

Conclusions: This study will be one of the first to examine a race-based stress reduction intervention in African American women and has the potential to improve the health of minoritized groups faced with chronic stress associated with experiencing racism and discrimination. We anticipate that RiSE will reduce stress-related symptoms, enhance adaptive coping, and reduce inflammation.

Trial registration: ClinicalTrials.gov NCT05902741; https://www.clinicaltrials.gov/study/NCT05902741.