Recruiting

Stress Reduction

Sponsor:

Loyola University

Code:

NCT05902741

Conditions

Racism

Stress

Inflammation

Eligibility Criteria

Sex: Female

Age: 50 - 70+

Healthy Volunteers: Not accepted

Interventions

RiSE

HEP

Study Details

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

Conditions

Racism

Stress

Inflammation

Study ID

NCT05902741

Start date

Oct 18, 2023

Status verified date

Aug, 2026

Completion date

Jan 31, 2028

Anticipated

Primary completion date

Jan 31, 2028

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: Female

Age: 50 - 70+

Healthy Volunteers: Not accepted

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)

Study Design

Enrollment

300 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Prevention

Interventions and Outcome Measures

Arms

experimental: 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.

active comparator: Health Education Program (HEP)

Health Education Program

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.

HEP

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

Primary outcome measure

  • Current perceived stress [ Time Frame: 8 months ]

Central Contacts and Locations

Central contacts

Karen Saban, RN, PhD

773-508-3990risestudy@luc.edu

Cara Joyce, PhD

464-220-9521cjoyce6@luc.edu

Locations

Loyola University Chicago

Recruiting

Maywood, Illinois, United States, 60153

Contacts

Karen Saban, RN, PhD

708-216-1244ksaban@luc.edu

Principal Investigator:

Karen Saban, RN, PhD

More Information

Sponsor

Loyola University

Last update posted

Aug 27, 2026

Last verified

Aug, 2026

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-09. This information was provided to ClinicalTrials.gov by Loyola University on 2026-08-27.