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| Name | Class |
|---|---|
| Columbia University | OTHER |
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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:
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:
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Resilience, Stress, and Ethnicity (RiSE) program | Experimental | 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:
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| Health Education Program (HEP) | Active Comparator | Health Education Program |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| RiSE | Behavioral | 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. |
| 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 |
| 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. |
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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:
Exclusion Criteria:
Self-identified African American women
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Karen Saban, RN, PhD | Contact | 773-508-3990 | risestudy@luc.edu | |
| Cara Joyce, PhD | Contact | 464-220-9521 | cjoyce6@luc.edu |
| Name | Affiliation | Role |
|---|---|---|
| Karen Saban, RN, PhD | Loyola University Chicago | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Loyola University Chicago | Recruiting | Maywood | Illinois | 60153 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 40250840 | Derived | Saban KL, Joyce C, Nyembwe A, Janusek L, Tell D, de la Pena P, Motley D, Shawahin L, Prescott L, Potts-Thompson S, Taylor JY. The Effectiveness of a Race-Based Stress Reduction Intervention on Improving Stress-Related Symptoms and Inflammation in African American Women at Risk for Cardiometabolic Disease: Protocol for Recruitment and Intervention for a Randomized Controlled Trial. JMIR Res Protoc. 2025 Apr 18;14:e65649. doi: 10.2196/65649. |
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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.
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| ID | Term |
|---|---|
| D063505 | Racism |
| D007249 | Inflammation |
| ID | Term |
|---|---|
| D011287 | Prejudice |
| D012919 | Social Behavior |
| D001519 | Behavior |
| D063508 | Social Discrimination |
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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.
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| HEP | Behavioral | The HEP group will consist of classes focusing on wellness promotion. Expert speakers provide the HEP classes (e.g dietician, pharmacist). |
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| 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 |
| D010335 |
| Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |