The Impact of a Race-Based Stress Reduction Intervention

Loyola University

Status: Enrolling

Conditions: Inflammation; Stress; Racism

Treatments: Behavioral: HEP; Behavioral: RiSE

Study type: Interventional

Funder types: Other

Identifiers

NCT05902741

214133

Details and patient eligibility

About

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

Full description

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.

Enrollment: 300 estimated patients

Sex: Female

Ages: 50 to 75 years old

Volunteers: No Healthy Volunteers

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:

  • Waist circumference >88 cm
  • Systolic BP>130 mmHg and/ or diastolic BP>88 mmHg or on antihypertensive medications
  • Diagnosed and/or being treated for hypercholesterolemia
  • History of Type 2 diabetes

Exclusion criteria

• 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
• Current smoker or has smoked in past 3 months
• Active cancer
• Active infection
• Substance abuse
• Cognitive or psychiatric disorder that would affect ability to participate in classes (Brief Screen for Cognitive Impairment total score of 8 or higher)

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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300 participants in 2 patient groups

Resilience, Stress, and Ethnicity (RiSE) program

Experimental group

Description:

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.

Treatment:

Behavioral: RiSE

Health Education Program (HEP)

Active Comparator group

Description:

Health Education Program

Treatment:

Behavioral: HEP