The Impact of a Race-Based Stress Reduction Intervention
- Conditions
- InflammationRacismStress
- Interventions
- Behavioral: RiSEBehavioral: HEP
- Registration Number
- NCT05902741
- Lead Sponsor
- Loyola University
- Brief Summary
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
- 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.
Recruitment & Eligibility
- Status
- RECRUITING
- Sex
- Female
- Target Recruitment
- 300
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Between the ages of 50 and 75
-
Female
-
Post-menopausal (without menstrual period for at least 12 consecutive months)
-
Self-identified AA or Black
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Able to write, read, speak English
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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
- 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
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Resilience, Stress, and Ethnicity (RiSE) program RiSE 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. Health Education Program (HEP) HEP Health Education Program
- Primary Outcome Measures
Name Time Method Current perceived stress 8 months Perceived Stress Scale (PSS-10). Scores range from 0 to 40 with higher score suggesting worse outcome.
- Secondary Outcome Measures
Name Time Method Inflammatory burden - Interleukin-1 beta (IL-1B) 8 months Salivary IL-1B
Inflammatory burden - Interferon gamma (IFN-γ), 8 months Salivary IFN-y
Inflammatory burden- C-reactive protein (CRP) 8 months Salivary CRP
Stress overload 8 months Stress Overload Scale. Scores range from 30 to 150 with higher score suggesting worse outcome.
Inflammatory burden - Interleukin-6 (IL-6) 8 months Salivary IL-6
Resistance and empowerment 8 months Resistance and Empowerment Against Racism Scale. Scores range from 26 to 130 with higher score suggesting better outcome.
Depressive symptoms 8 months Beck Depression Inventory (BDI). Scores range from 0 to 63 with higher score suggesting worse outcome.
Sleep disturbance 8 months NIH PROMIS Short Form v1.0
Inflammatory burden - Tumor necrosis factor-alpha (TNF-alpha) 8 months Salivary TNF-alpha
General coping 8 months Ways of Coping Questionnaire. Scores range for 0 to 198 for total scale with higher scores suggesting more coping.
Coping with discrimination 8 months Coping with Discrimination Scale. Scores range from 25 to 150 with higher scores suggesting more coping.
Internalized racism 8 months Appropriated Racial Oppression Scale. Scores range from 24 to 168 with higher score suggesting worse outcome.
DNA methylation 8 months Targeted DNA methylation of targeted candidate genes
Anxiety 8 months Generalized Anxiety Disorder-7 (GAD-7). Scores range from 0 to 21 with higher score suggesting worse outcome.
Fatigue 8 months NIH Patient Reported Outcomes Measurement Information System (PROMIS) Fatigue Short Form 8a
Trial Locations
- Locations (1)
Loyola University Chicago
🇺🇸Maywood, Illinois, United States