The Impact of a Race-Based Stress Reduction Intervention

NCT05902741 | Recruiting

• 1 other identifier: 214133
• Study Type: interventional
• Target: 300
• Locations: 1 country
• Sites: 1

Brief Summary

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:
• Prior to starting the intervention
• Mid-way through the intervention (Week 4)
• End of the intervention (Week 8)
• Six (6) months after the completion of the intervention

Conditions

Racism; Stress; Inflammation

Outcome Measures

Primary Outcomes (1)

• Current perceived stress

  Perceived Stress Scale (PSS-10). Scores range from 0 to 40 with higher score suggesting worse outcome.

  8 months

Secondary Outcomes (15)

• General coping

  8 months

• Coping with discrimination

  8 months

• Internalized racism

  8 months

• Resistance and empowerment

  8 months

• DNA methylation

  8 months

Study Arms (2)

Resilience, Stress, and Ethnicity (RiSE) program

EXPERIMENTAL

Resilience, Stress, and Ethnicity (RiSE) program is an 8-session weekly group-based intervention that integrates cognitive-behavioral strategies focused on the biopsychosocial impact of racism, racial identity development, and empowerment. RiSE has three primary components: 1. processing and sharing experiences related to race based stress, 2. psychoeducation on the biopsychosocial impact of racism, 3. skill building and empowerment.

Behavioral: RiSE

Health Education Program (HEP)

ACTIVE COMPARATOR

Health Education Program

Behavioral: HEP

Interventions

RiSE BEHAVIORAL

RiSE provides participants with a platform to share the emotional impact of race-based stress and to offer supportive listening to their peers. Participants explicitly discuss the experiences they have as African American women, taking into account the ways which the interaction between their racial and gender identities shapes their experiences. Facilitators review difficulties associated with addressing racism and unique experiences of Black women at interpersonal and structural levels, and provide evidence of strategies to promote effective communication and internal emotional regulation regarding experiences of racism. Facilitators provide psychoeducation on intersectionality, structural racism, overt racism, microaggressions, and internalized racism. Following this education, facilitators help participants utilize cognitive-behavioral strategies to understand consequent thoughts, feelings, and actions associated with such experiences.

Resilience, Stress, and Ethnicity (RiSE) program

HEP BEHAVIORAL

The HEP group will consist of classes focusing on wellness promotion. Expert speakers provide the HEP classes (e.g dietician, pharmacist).

Health Education Program (HEP)

Eligibility Criteria

• Age: 50 Years - 75 Years
• Gender Eligibility Details: Self-identified African American women
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Between the ages of 50 and 75
• Female
• Post-menopausal (without menstrual period for at least 12 consecutive months)
• Self-identified AA or Black
• Able to write, read, speak English
• Must have at least 1 of any of the following:
• Waist circumference \>88 cm
• Systolic BP\>130 mmHg and/ or diastolic BP\>88 mmHg or on antihypertensive medications
• Diagnosed and/or being treated for hypercholesterolemia
• History of Type 2 diabetes

You may not qualify if:

• History of myocardial infarction or ischemic heart disease/angina, stent placement, coronary artery bypass, left ventricular hypertrophy, congestive heart failure, or ischemic stroke
• Any major immune-related disease (e.g., rheumatoid arthritis. lupus)
• Use of immune-altering medications, such as glucocorticoids
• Periodontal disease, bleeding gums, dental work in past 72 hours
• Current smoker or has smoked in past 3 months
• Active cancer
• Active infection
• Substance abuse
• Cognitive or psychiatric disorder that would affect ability to participate in classes (Brief Screen for Cognitive Impairment total score of 8 or higher)

Sponsors & Collaborators

• Loyola University: lead
• Columbia University: collaborator

Study Sites (1)

Loyola University Chicago

Maywood, Illinois, 60153, United States

RECRUITING

Related Publications (1)

• Saban KL, Joyce C, Nyembwe A, Janusek L, Tell D, de la Pena P, Motley D, Shawahin L, Prescott L, Potts-Thompson S, Taylor JY. 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. JMIR Res Protoc. 2025 Apr 18;14:e65649. doi: 10.2196/65649.

  PMID: 40250840 DERIVED

MeSH Terms

Conditions

Racism; Inflammation

Condition Hierarchy (Ancestors)

Prejudice; Social Behavior; Behavior; Social Discrimination; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Karen Saban, RN, PhD

  Loyola University Chicago

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Karen Saban, RN, PhD

CONTACT

773-508-3990; risestudy@luc.edu

Cara Joyce, PhD

CONTACT

464-220-9521; cjoyce6@luc.edu

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Model Details: Self-identified African American women will be randomized to either the race-based stress reduction intervention group (Resilience, Stress, and Ethnicity \[RiSE\]) or the HEP.

Study Record Dates

• First Submitted: May 2, 2023
• First Posted: June 15, 2023
• Study Start: October 18, 2023
• Primary Completion (Estimated): January 31, 2028
• Study Completion (Estimated): January 31, 2028
• Last Updated: September 9, 2025

Record last verified: 2025-07

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, ICF, CSR, ANALYTIC CODE
• Time Frame: The repository will make the data accessible within 3 years of last participant study visit or at the end of the performance period, or no later than the date of online publication, whichever is soon. Genomic data will be shared according to Genomic Data Sharing (GDS) policy, which requires that genomic data must be submitted within 3 months following data generation, and released within 6 months of data submission to the repository or at acceptance of the publication, whichever is first. Data will be preserved within the repository for at least three years following the completion of the grant, as required by federal retention guidelines.
• Access Criteria: Data will be shared with controlled access in the dbGAP for non-commercial research use by qualified investigators, as allowed by the participants' informed consent and the Institutional Certification. Due to ethical considerations, access to the resulting scientific data will be limited and approved by the Multiple Principal Investigators (MPI) Saban and Taylor.

Locations

US (1)