The Impact of a Race-Based Stress Reduction Intervention

Study Overview
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Brief Summary
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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

Detailed Description
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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.

Official Title
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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

Conditions
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Stress, Racism, Inflammation

Intervention / Treatment
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* Behavioral: RiSE
* Behavioral: HEP


Participation Criteria
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Eligibility Criteria
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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)

Ages Eligible for Study
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Minimum Age: 50 Years
Maximum Age: 75 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional 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.
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: RiSE<br>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. | Behavioral: RiSE<br>* 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.<br>|
| Active Comparator: HEP<br>Health Education Program | Behavioral: HEP<br>* The HEP group will consist of classes focusing on wellness promotion. Expert speakers provide the HEP classes (e.g dietician, pharmacist).<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Current perceived stress | Perceived Stress Scale (PSS-10). Scores range from 0 to 40 with higher score suggesting worse outcome. | 8 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| General coping | Ways of Coping Questionnaire. Scores range for 0 to 198 for total scale with higher scores suggesting more coping. | 8 months | 
| Coping with discrimination | Coping with Discrimination Scale. Scores range from 25 to 150 with higher scores suggesting more coping. | 8 months | 
| Internalized racism | Appropriated Racial Oppression Scale. Scores range from 24 to 168 with higher score suggesting worse outcome. | 8 months | 
| Resistance and empowerment | Resistance and Empowerment Against Racism Scale. Scores range from 26 to 130 with higher score suggesting better outcome. | 8 months | 
| DNA methylation | Targeted DNA methylation of targeted candidate genes | 8 months | 
| Stress overload | Stress Overload Scale. Scores range from 30 to 150 with higher score suggesting worse outcome. | 8 months | 
| Depressive symptoms | Beck Depression Inventory (BDI). Scores range from 0 to 63 with higher score suggesting worse outcome. | 8 months | 
| Anxiety | Generalized Anxiety Disorder-7 (GAD-7). Scores range from 0 to 21 with higher score suggesting worse outcome. | 8 months | 
| Fatigue | NIH Patient Reported Outcomes Measurement Information System (PROMIS) Fatigue Short Form 8a | 8 months | 
| Sleep disturbance | NIH PROMIS Short Form v1.0 | 8 months | 
| Inflammatory burden- C-reactive protein (CRP) | Salivary CRP | 8 months | 
| Inflammatory burden - Tumor necrosis factor-alpha (TNF-alpha) | Salivary TNF-alpha | 8 months | 
| Inflammatory burden - Interleukin-6 (IL-6) | Salivary IL-6 | 8 months | 
| Inflammatory burden - Interleukin-1 beta (IL-1B) | Salivary IL-1B | 8 months | 
| Inflammatory burden - Interferon gamma (IFN-γ), | Salivary IFN-y | 8 months |