Health TrialsbyHealthPanel

The Impact of a Race-Based Stress Reduction Intervention

ConditionsRacismStressInflammation
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexFemale
Age50-75
SponsorLoyola University

About this trial

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

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Between the ages of 50 and 75

Female

Post-menopausal (without menstrual period for at least 12 consecutive months)

Self-identified AA or Black

Disqualifiers

History of myocardial infarction or ischemic heart disease/angina, stent placement, coronary artery bypass, left ventricular hypertrophy, congestive heart failure, or ischemic stroke

Any major immune-related disease (e.g., rheumatoid arthritis. lupus)

Use of immune-altering medications, such as glucocorticoids

Periodontal disease, bleeding gums, dental work in past 72 hours

Trial design

Design model

Parallel

Treatments tested in this trial

  • 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).

Treatment groups

300 Participants
are divided into 2 treatment groups
Group A: Resilience, Stress, and Ethnicity (RiSE) programExperimental treatment 1 intervention
Group B: Health Education Program (HEP)Active comparator 1 intervention

Trial outcomes

Primary outcomes

1

Current perceived stress

Perceived Stress Scale (PSS-10). Scores range from 0 to 40 with higher score suggesting worse outcome.

Time frame
8 months

Secondary outcomes

1

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
2

Coping with discrimination

Coping with Discrimination Scale. Scores range from 25 to 150 with higher scores suggesting more coping.

Time frame
8 months
3

Internalized racism

Appropriated Racial Oppression Scale. Scores range from 24 to 168 with higher score suggesting worse outcome.

Time frame
8 months
4

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

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Loyola University

Lead sponsor

Columbia University

Collaborator

Source ClinicalTrials.gov
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