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NCT Number: NCT05902741

The Impact of a Race-Based Stress Reduction Intervention

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

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Key information

Age range

50 year–75 year

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

Loyola University Chicago

Maywood, Illinois, 60153, United States

Location status: Recruiting

Location contact

Karen Saban, RN, PhD

CONTACT

[email protected]

708-216-1244

Karen Saban, RN, PhD

PRINCIPAL_INVESTIGATOR

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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)

Treatment and study plan

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.

HEP

Behavioral

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

Primary outcomes

  1. Current perceived stress

    Time frame: 8 months

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

Secondary outcomes

  1. General coping

    Time frame: 8 months

    Ways of Coping Questionnaire. Scores range for 0 to 198 for total scale with higher scores suggesting more coping.

  2. Coping with discrimination

    Time frame: 8 months

    Coping with Discrimination Scale. Scores range from 25 to 150 with higher scores suggesting more coping.

  3. Internalized racism

    Time frame: 8 months

    Appropriated Racial Oppression Scale. Scores range from 24 to 168 with higher score suggesting worse outcome.

  4. Resistance and empowerment

    Time frame: 8 months

    Resistance and Empowerment Against Racism Scale. Scores range from 26 to 130 with higher score suggesting better outcome.

  5. DNA methylation

    Time frame: 8 months

    Targeted DNA methylation of targeted candidate genes

  6. Stress overload

    Time frame: 8 months

    Stress Overload Scale. Scores range from 30 to 150 with higher score suggesting worse outcome.

  7. Depressive symptoms

    Time frame: 8 months

    Beck Depression Inventory (BDI). Scores range from 0 to 63 with higher score suggesting worse outcome.

  8. Anxiety

    Time frame: 8 months

    Generalized Anxiety Disorder-7 (GAD-7). Scores range from 0 to 21 with higher score suggesting worse outcome.

  9. Fatigue

    Time frame: 8 months

    NIH Patient Reported Outcomes Measurement Information System (PROMIS) Fatigue Short Form 8a

  10. Sleep disturbance

    Time frame: 8 months

    NIH PROMIS Short Form v1.0

  11. Inflammatory burden- C-reactive protein (CRP)

    Time frame: 8 months

    Salivary CRP

  12. Inflammatory burden - Tumor necrosis factor-alpha (TNF-alpha)

    Time frame: 8 months

    Salivary TNF-alpha

  13. Inflammatory burden - Interleukin-6 (IL-6)

    Time frame: 8 months

    Salivary IL-6

  14. Inflammatory burden - Interleukin-1 beta (IL-1B)

    Time frame: 8 months

    Salivary IL-1B

  15. Inflammatory burden - Interferon gamma (IFN-γ),

    Time frame: 8 months

    Salivary IFN-y

Study contacts

Contact information is provided by the study sponsor or research team.

Cara Joyce, PhD

CONTACT

[email protected]

464-220-9521

Karen Saban, RN, PhD

CONTACT

[email protected]

773-508-3990

Sponsors and collaborators

Lead sponsor

Loyola University

Other

Collaborators

  • Columbia University

Registry information

Official study title

The Impact of a Race-Based Stress Reduction Intervention on Well-Being, Inflammation, and DNA Methylation in African American Women at Risk for Cardiometabolic Disease

Important dates

Study start
2023
Primary completion
2028
Study completion
2028
First posted
Jun 15, 2023
Registry last updated
Sep 9, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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