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
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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
SINGLE
Enrollment
300
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).
Loyola University Chicago
Maywood, Illinois, United States
RECRUITINGCurrent perceived stress
Perceived Stress Scale (PSS-10). Scores range from 0 to 40 with higher score suggesting worse outcome.
Time frame: 8 months
General coping
Ways of Coping Questionnaire. Scores range for 0 to 198 for total scale with higher scores suggesting more coping.
Time frame: 8 months
Coping with discrimination
Coping with Discrimination Scale. Scores range from 25 to 150 with higher scores suggesting more coping.
Time frame: 8 months
Internalized racism
Appropriated Racial Oppression Scale. Scores range from 24 to 168 with higher score suggesting worse outcome.
Time frame: 8 months
Resistance and empowerment
Resistance and Empowerment Against Racism Scale. Scores range from 26 to 130 with higher score suggesting better outcome.
Time frame: 8 months
DNA methylation
Targeted DNA methylation of targeted candidate genes
Time frame: 8 months
Stress overload
Stress Overload Scale. Scores range from 30 to 150 with higher score suggesting worse outcome.
Time frame: 8 months
Depressive symptoms
Beck Depression Inventory (BDI). Scores range from 0 to 63 with higher score suggesting worse outcome.
Time frame: 8 months
Anxiety
Generalized Anxiety Disorder-7 (GAD-7). Scores range from 0 to 21 with higher score suggesting worse outcome.
Time frame: 8 months
Fatigue
NIH Patient Reported Outcomes Measurement Information System (PROMIS) Fatigue Short Form 8a
Time frame: 8 months
Sleep disturbance
NIH PROMIS Short Form v1.0
Time frame: 8 months
Inflammatory burden- C-reactive protein (CRP)
Salivary CRP
Time frame: 8 months
Inflammatory burden - Tumor necrosis factor-alpha (TNF-alpha)
Salivary TNF-alpha
Time frame: 8 months
Inflammatory burden - Interleukin-6 (IL-6)
Salivary IL-6
Time frame: 8 months
Inflammatory burden - Interleukin-1 beta (IL-1B)
Salivary IL-1B
Time frame: 8 months
Inflammatory burden - Interferon gamma (IFN-γ),
Salivary IFN-y
Time frame: 8 months
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.