The Impact of a Race-Based Stress Reduction Intervention

Inflammation Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05902741
• Other study ID #: 214133
• Status: Recruiting
• Phase: N/A
• Start date: October 18, 2023
• Est. completion date: January 31, 2028

Study information

• Verified date: January 2024
• Source: Loyola University
• Contact: Karen Saban, RN, PhD
• Phone: 708-216-1244
• Email: ksaban[@]luc.edu
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 300
• Est. completion date: January 31, 2028
• Est. primary completion date: January 31, 2028
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 50 Years to 75 Years

Eligibility

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)

Related Conditions & MeSH terms

• Inflammation
• Racism
• Stress

Intervention

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

Locations

Country	Name	City	State
United States	Loyola University Chicago	Maywood	Illinois

Sponsors (2)

Lead Sponsor	Collaborator
Loyola University	Columbia University

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Current perceived stress	Perceived Stress Scale (PSS-10). Scores range from 0 to 40 with higher score suggesting worse outcome.	8 months
Secondary	General coping	Ways of Coping Questionnaire. Scores range for 0 to 198 for total scale with higher scores suggesting more coping.	8 months
Secondary	Coping with discrimination	Coping with Discrimination Scale. Scores range from 25 to 150 with higher scores suggesting more coping.	8 months
Secondary	Internalized racism	Appropriated Racial Oppression Scale. Scores range from 24 to 168 with higher score suggesting worse outcome.	8 months
Secondary	Resistance and empowerment	Resistance and Empowerment Against Racism Scale. Scores range from 26 to 130 with higher score suggesting better outcome.	8 months
Secondary	DNA methylation	Targeted DNA methylation of targeted candidate genes	8 months
Secondary	Stress overload	Stress Overload Scale. Scores range from 30 to 150 with higher score suggesting worse outcome.	8 months
Secondary	Depressive symptoms	Beck Depression Inventory (BDI). Scores range from 0 to 63 with higher score suggesting worse outcome.	8 months
Secondary	Anxiety	Generalized Anxiety Disorder-7 (GAD-7). Scores range from 0 to 21 with higher score suggesting worse outcome.	8 months
Secondary	Fatigue	NIH Patient Reported Outcomes Measurement Information System (PROMIS) Fatigue Short Form 8a	8 months
Secondary	Sleep disturbance	NIH PROMIS Short Form v1.0	8 months
Secondary	Inflammatory burden- C-reactive protein (CRP)	Salivary CRP	8 months
Secondary	Inflammatory burden - Tumor necrosis factor-alpha (TNF-alpha)	Salivary TNF-alpha	8 months
Secondary	Inflammatory burden - Interleukin-6 (IL-6)	Salivary IL-6	8 months
Secondary	Inflammatory burden - Interleukin-1 beta (IL-1B)	Salivary IL-1B	8 months
Secondary	Inflammatory burden - Interferon gamma (IFN-?),	Salivary IFN-y	8 months