The Impact of a Race-Based Stress Reduction Intervention

Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexFemale
Age50-75
SponsorLoyola University

About this trial

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

Eligibility criteria

Qualifiers

Between the ages of 50 and 75

Female

Post-menopausal (without menstrual period for at least 12 consecutive months)

Self-identified AA or Black

Disqualifiers

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

Trial design

Treatments tested in this trial

  • RiSE
  • HEP

Treatment groups

300 Participants
are divided into 2 treatment groups

Sponsors and collaborators

Loyola University

Lead sponsor

Columbia University

Collaborator