Loyola University Chicago
Maywood, Illinois, 60153, United States
Location status: Recruiting
Location contact
Karen Saban, RN, PhD
CONTACT
Karen Saban, RN, PhD
PRINCIPAL_INVESTIGATOR
NCT Number: NCT05902741
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
Interested in participating?
Request Info50 year–75 year
Female
Interventional
Not applicable
Maywood, Illinois, 60153, United States
Location status: Recruiting
Karen Saban, RN, PhD
CONTACT
Karen Saban, RN, PhD
PRINCIPAL_INVESTIGATOR
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.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
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).
Time frame: 8 months
Perceived Stress Scale (PSS-10). Scores range from 0 to 40 with higher score suggesting worse outcome.
Time frame: 8 months
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 Scale. Scores range from 25 to 150 with higher scores suggesting more coping.
Time frame: 8 months
Appropriated Racial Oppression Scale. Scores range from 24 to 168 with higher score suggesting worse outcome.
Time frame: 8 months
Resistance and Empowerment Against Racism Scale. Scores range from 26 to 130 with higher score suggesting better outcome.
Time frame: 8 months
Targeted DNA methylation of targeted candidate genes
Time frame: 8 months
Stress Overload Scale. Scores range from 30 to 150 with higher score suggesting worse outcome.
Time frame: 8 months
Beck Depression Inventory (BDI). Scores range from 0 to 63 with higher score suggesting worse outcome.
Time frame: 8 months
Generalized Anxiety Disorder-7 (GAD-7). Scores range from 0 to 21 with higher score suggesting worse outcome.
Time frame: 8 months
NIH Patient Reported Outcomes Measurement Information System (PROMIS) Fatigue Short Form 8a
Time frame: 8 months
NIH PROMIS Short Form v1.0
Time frame: 8 months
Salivary CRP
Time frame: 8 months
Salivary TNF-alpha
Time frame: 8 months
Salivary IL-6
Time frame: 8 months
Salivary IL-1B
Time frame: 8 months
Salivary IFN-y
Contact information is provided by the study sponsor or research team.
Cara Joyce, PhD
CONTACT
Karen Saban, RN, PhD
CONTACT
Loyola University
Other
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
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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