An interventional study of RiSE and HEP in Racism, Stress and Inflammation, sponsored by Loyola University. Recruiting at 1 site in United States. Open to female participants aged 50 Years to 75 Years. Per ClinicalTrials.gov, last updated 2026-08-27.
Sponsored by Loyola University · Not applicable, Interventional, and Prevention
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.
47 studies on the registry are indexed under Racism; 8 are open to participants now.
This study's planned enrollment of 300 is above the median of 106 across 34 interventional studies indexed under Racism.
Browse Racism studies →Loyola University is the lead sponsor of 134 studies on the registry; 15 are open to participants now.
Of its 26 completed or terminated interventional studies of FDA-regulated products, 23 (88%) have results posted.
Counted across the registry records on this site, refreshed daily.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Must have at least 1 of any of the following:
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Periods have stopped for good: usually no period for 12 months in a row without another medical reason, sometimes confirmed by a blood test (FSH).
Anti-inflammatory medicines such as prednisone, prednisolone and dexamethasone — not the anabolic steroids used for muscle.
Studies differ in what they allow: check which steroid medicines, routes (tablets, injections, creams, inhalers, eye drops) and doses this study accepts.
Postmenopausal
Periods have stopped for good: usually no period for 12 months in a row without another medical reason, sometimes confirmed by a blood test (FSH).
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Corticosteroids (steroids)
Anti-inflammatory medicines such as prednisone, prednisolone and dexamethasone — not the anabolic steroids used for muscle.
Studies differ in what they allow: check which steroid medicines, routes (tablets, injections, creams, inhalers, eye drops) and doses this study accepts.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
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.
Behavioral: RiSE
Health Education Program
Behavioral: HEP
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).
Current 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
Plan to share: Yes — 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.
Supporting information: Study protocol, Informed consent form, Clinical study report, Analytic code
Time frame: 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.
Access criteria: 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.
Started Oct 2023 (actual). Primary completion is estimated for Jan 2028, 51 months after the start.
Of 29 non-industry interventional studies with no phase under Racism, half reached primary completion within 32 months of starting (the median), counting those still running; a quarter within 14 and three quarters within 41. This study's planned 51 months is above that.
Counting every sponsor, half of 29 studies reached it within 32 months; a quarter within 14 and three quarters within 41.
How these figures are worked out, and which studies are left out of them.
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