The Impact of a Race-Based Stress Reduction Intervention

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

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: Prior to starting the intervention Mid-way through the intervention (Week 4) End of the intervention (Week 8) Six (6) months after the completion of the intervention

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.

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.

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: processing and sharing experiences related to race based stress, psychoeducation on the biopsychosocial impact of racism, skill building and empowerment.

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.

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

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

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

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

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

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

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

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

Inclusion Criteria: Between the ages of 50 and 70 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)

Genomic data will be individual level data. Analysis of genomic DNA will link genotype to phenotypic information obtained as part of this study. Genomic data will include Genome wide association (GWAS) and DNA methylation (EWAS). Genomic data will be obtained from saliva taken at baseline, at completion of intervention, and 6 months after completion of intervention. The protocol, sample informed consent, case report forms, data dictionary, and code book will be made accessible in data repositories where data are shared. For data submitted to Database of Genotypes and Phenotypes (dbGaP), variable-level metadata will be provided using details of Common Data Elements, definitions, and standards used for data collection and sharing.

The repository will make the data accessible within 3 years of last participant study visit or at the end of the performance period, or no later than the date of online publication, whichever is soon. Genomic data will be shared according to Genomic Data Sharing (GDS) policy, which requires that genomic data must be submitted within 3 months following data generation, and released within 6 months of data submission to the repository or at acceptance of the publication, whichever is first. Data will be preserved within the repository for at least three years following the completion of the grant, as required by federal retention guidelines.

Data will be shared with controlled access in the dbGAP for non-commercial research use by qualified investigators, as allowed by the participants' informed consent and the Institutional Certification. Due to ethical considerations, access to the resulting scientific data will be limited and approved by the Multiple Principal Investigators (MPI) Saban and Taylor.