The Impact of a Race-Based Stress Reduction Intervention
Purpose
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
Eligibility
- Eligible Ages
- Between 50 Years and 75 Years
- Eligible Sex
- Female
- Accepts Healthy Volunteers
- No
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
- Phase
- N/A
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel Assignment
- Intervention Model Description
- 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.
- Primary Purpose
- Prevention
- Masking
- Single (Outcomes Assessor)
Arm Groups
| Arm | Description | Assigned Intervention |
|---|---|---|
|
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 |
|
Recruiting Locations
Maywood 4901514, Illinois 4896861 60153
More Details
- NCT ID
- NCT05902741
- Status
- Recruiting
- Sponsor
- Loyola University
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.