The Impact of a Race-Based Stress Reduction Intervention

Sponsor

Loyola University (Other)

Overall Status

Recruiting

CT.gov ID

NCT05902741

Collaborator

Columbia University (Other)

300

Enrollment

Location

Arms

71.7

Anticipated Duration (Months)

4.2

Patients Per Site Per Month

Study Details

Study Description

Brief 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:

Prior to starting the intervention
Mid-way through the intervention (Week 4)
End of the intervention (Week 8)
Six (6) months after the completion of the intervention

Condition or Disease	Intervention/Treatment	Phase
Racism Stress Inflammation	Behavioral: RiSE Behavioral: HEP	N/A

Detailed 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.

Study Design

Study Type:

Interventional

Anticipated Enrollment :

300 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Intervention Model Description:

Self-identified African American women will be randomized to either the race-based stress reduction intervention group (Resilience, Stress, and Ethnicity [RiSE]) or the HEP.Self-identified African American women will be randomized to either the race-based stress reduction intervention group (Resilience, Stress, and Ethnicity [RiSE]) or the HEP.

Masking:

None (Open Label)

Primary Purpose:

Treatment

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

Actual Study Start Date :

Mar 10, 2023

Anticipated Primary Completion Date :

Mar 1, 2028

Anticipated Study Completion Date :

Mar 1, 2029

Arms and Interventions

Arm	Intervention/Treatment
Experimental: RiSE 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: processing and sharing experiences related to race based stress, psychoeducation on the biopsychosocial impact of racism, skill building and empowerment.	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.
Active Comparator: HEP Health Education Program	Behavioral: HEP The HEP group will consist of classes focusing on wellness promotion. Expert speakers provide the HEP classes (e.g dietician, pharmacist).

Arm

Intervention/Treatment

Experimental: RiSE

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: processing and sharing experiences related to race based stress, psychoeducation on the biopsychosocial impact of racism, skill building and empowerment.

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.

Active Comparator: HEP

Health Education Program

Behavioral: HEP

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

Outcome Measures

Primary Outcome Measures

Current perceived stress [8 months]
Perceived Stress Scale (PSS-10)
Stress overload [8 months]
Stress Overload Scale
Depressive symptoms [8 months]
Beck Depression Inventory (BDI)
Anxiety [8 months]
Generalized Anxiety Disorder-7 (GAD-7)
Fatigue [8 months]
NIH Patient Reported Outcomes Measurement Information System (PROMIS) Fatigue Short Form 8a
Sleep disturbance [8 months]
NIH PROMIS Short Form v1.0
Inflammatory burden- C-reactive protein (CRP) [8 months]
Salivary CRP
Inflammatory burden - Tumor necrosis factor-alpha (TNF-alpha) [8 months]
Salivary TNF-alpha
Inflammatory burden - Interleukin-6 (IL-6) [8 months]
Salivary IL-6
Inflammatory burden - Interleukin-1 beta (IL-1B) [8 months]
Salivary IL-1B
Inflammatory burden - Interferon gamma (IFN-γ), [8 months]
Salivary IFN-y

Secondary Outcome Measures

General coping [8 months]
Ways of Coping Questionnaire
Coping with discrimination [8 months]
Coping with Discrimination Scale
Internalized racism [8 months]
Appropriated Racial Oppression Scale
Resistance and empowerment [8 months]
Resistance and Empowerment Against Racism Scale
DNA methylation [8 months]
Targeted DNA methylation of targeted candidate genes

Eligibility Criteria

Criteria

Ages Eligible for Study:

50 Years to 70 Years

Sexes Eligible for Study:

Female

Accepts Healthy Volunteers:

Inclusion Criteria:

Between the ages of 50 and 70
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)

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Loyola University Chicago	Maywood	Illinois	United States	60153

Sponsors and Collaborators

Loyola University
Columbia University

Investigators

Principal Investigator: Karen Saban, RN, PhD, Loyola University Chicago

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Loyola University

ClinicalTrials.gov Identifier:

NCT05902741

Other Study ID Numbers:

LU 214133

First Posted:

Jun 15, 2023

Last Update Posted:

Jun 15, 2023

Last Verified:

Jun 1, 2023

Individual Participant Data (IPD) Sharing Statement:

Yes

Plan to Share IPD:

Yes

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Additional relevant MeSH terms:

Inflammation

Study Results

No Results Posted as of Jun 15, 2023