The Impact of a Race-Based Stress Reduction Intervention

NCT ID: NCT05902741

Last Updated: 2025-09-09

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: NA
• Total Enrollment: 300 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2023-10-18
• Study Completion Date: 2028-01-31

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:

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

Detailed Description

Participants of both programs - RiSE and Health Education Program (HEP) - will meet weekly for 8 consecutive weeks for approximately 2 hours every week. Two booster sessions will occur one month and two months after completion of the interventions. Classes will meet synchronously over Zoom. RiSE classes will be facilitated by two trained clinical psychologists. Expert speakers will be hired to provide the HEP classes (e.g dietician, pharmacist). The investigators will vary the time of day for each 8- week program in order to meet the scheduling needs of participants. Cohorts of 9-12 participants each and sessions for the treatment and control group will be provided concurrently. Topics for the health education program (HEP) (attention-control) were selected so they would not confound the overall objectives of the RiSE program.

Conditions

Racism; Stress; Inflammation

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: PREVENTION
• Blinding Strategy: SINGLE

Study Groups

Resilience, Stress, and Ethnicity (RiSE) program

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.

Group Type: EXPERIMENTAL

RiSE

Intervention Type: 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.

Health Education Program (HEP)

Health Education Program

Group Type: ACTIVE_COMPARATOR

HEP

Intervention Type: BEHAVIORAL

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

Interventions

RiSE

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.

Intervention Type: BEHAVIORAL

HEP

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

Intervention Type: BEHAVIORAL

Eligibility Criteria

Inclusion Criteria

• 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

Exclusion Criteria

• 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)

• Minimum Eligible Age: 50 Years
• Maximum Eligible Age: 75 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: No

Sponsors

Columbia University

OTHER

Sponsor Role: collaborator

Loyola University

OTHER

Sponsor Role: lead

Responsible Party

Karen Saban

Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Karen Saban, RN, PhD

Role: PRINCIPAL_INVESTIGATOR

Loyola University Chicago

Locations

Loyola University Chicago

Maywood, Illinois, United States

Site Status: RECRUITING

Countries

United States

Central Contacts

Karen Saban, RN, PhD

Role: CONTACT

risestudy@luc.edu

773-508-3990

Cara Joyce, PhD

Role: CONTACT

cjoyce6@luc.edu

464-220-9521

Facility Contacts

Karen Saban, RN, PhD

Role: primary

ksaban@luc.edu

708-216-1244

References

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.

Reference Type: DERIVED

PMID: 40250840 (View on PubMed)

Other Identifiers

214133

Identifier Type: -

Identifier Source: org_study_id