The Impact of a Race-Based Stress Reduction Intervention

Part of paid clinical trials in Maywood, Illinois.

Sponsor
Loyola University
Study ID
NCT05902741
Status
Recruiting
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Conditions

  • Inflammation
  • Racism
  • Stress

Eligibility Criteria

Sex
FEMALE
Age
50 Years - 75 Years
Healthy Volunteers
Not accepted

Interventions

  • 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.
  • HEP — BEHAVIORAL
    The HEP group will consist of classes focusing on wellness promotion. Expert speakers provide the HEP classes (e.g dietician, pharmacist).

Study Details

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

Key Dates

Start date
Oct 18, 2023
Status verified
Jul 2025
Primary completion
Jan 31, 2028
Completion
Jan 31, 2028

Study Design

Enrollment
300 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION

Arms

  • Experimental: Resilience, Stress, and Ethnicity (RiSE) program
    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.
  • Active Comparator: Health Education Program (HEP)
    Health Education Program

Primary Outcome Measure

Current perceived stress [ Time Frame: 8 months ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
Loyola University ChicagoMaywoodIllinois60153
Karen Saban, RN, PhD
[email protected]
708-216-1244
Karen Saban, RN, PhD (PRINCIPAL_INVESTIGATOR)

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By research site
Loyola University Chicago· Maywood, IL

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