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Stress Reduction Intervention for Racism-Related Stress

N/A

Recruiting

Led By Karen Saban, RN, PhD

Research Sponsored by Loyola University

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Be older than 18 years old

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 8 months

Awards & highlights

Study Summary

This trial aims to learn if an intervention helps reduce stress, improve well-being, and reduce inflammation and epigenetic changes in African American women at risk for heart/metabolic diseases.

Who is the study for?

This trial is for African American women aged 50-70, post-menopausal, who can read and speak English. They must have risk factors for heart or metabolic disease like high blood pressure, large waist circumference, high cholesterol, or Type 2 diabetes. Excluded are those on immune-altering meds, with recent dental issues, smokers within 3 months, active cancer/infection/substance abuse issues or significant cardiovascular history.Check my eligibility

What is being tested?

The study compares two programs: RiSE (Resilience and Stress Education) focusing on stress reduction related to racial experiences versus a general Health Education program (HEP). Both groups meet online weekly for eight weeks. The impact on well-being and biological markers of stress will be measured through saliva tests and health check-ups before the intervention starts until six months after it ends.See study design

What are the potential side effects?

Since this trial involves non-medical interventions focused on education and behavioral strategies rather than drugs or medical procedures, there are no direct side effects as typically associated with medication trials.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 8 months

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~8 months

This trial's timeline: 3 weeks for screening, Varies for treatment, and 8 months for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Current perceived stress

Secondary outcome measures

Anxiety

Coping with discrimination

DNA methylation

+12 more

Trial Design

2Treatment groups

Experimental Treatment

Active Control

Group I: Resilience, Stress, and Ethnicity (RiSE) programExperimental Treatment1 Intervention

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.

Group II: Health Education Program (HEP)Active Control1 Intervention

Health Education Program

Do I qualify?Apply below to find out

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Who is running the clinical trial?

Loyola UniversityLead Sponsor

156 Previous Clinical Trials

30,634 Total Patients Enrolled

Columbia UniversityOTHER

1,433 Previous Clinical Trials

2,446,959 Total Patients Enrolled

9 Trials studying Inflammation

13,699 Patients Enrolled for Inflammation

Karen Saban, RN, PhDPrincipal InvestigatorLoyola University Chicago

Media Library

HEP Clinical Trial Eligibility Overview. Trial Name: NCT05902741 — N/A

Inflammation Research Study Groups: Health Education Program (HEP), Resilience, Stress, and Ethnicity (RiSE) program

Inflammation Clinical Trial 2023: HEP Highlights & Side Effects. Trial Name: NCT05902741 — N/A

HEP 2023 Treatment Timeline for Medical Study. Trial Name: NCT05902741 — N/A

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Who qualifies for participation in this clinical trial?

"The prerequisites for participation in this trial necessitate that candidates are between 50 and 70 years of age, while also exhibiting symptoms associated with inflammation. Consequently, 300 participants need to be recruited into the study."

Answered by AI

Is the age requirement for participants in this trial greater than twenty years?

"The qualifications for enrolment in this medical trial are that prospective participants must be between 50 and 70 years of age."

Answered by AI

How many volunteers are actively participating in this research?

"Affirmative. The clinical trial is enrolling participants, as per the information uploaded to clinicaltrials.gov which was posted on March 10th 2023 and most recently updated on June 5th 2023. 300 patients need to be enrolled from 1 medical centre in total."

Answered by AI

What kind of outcomes is this investigation attempting to demonstrate?

"This 8-month trial seeks to examine the effects of stress overload. To measure success, researchers will analyze three secondary outcomes: coping with discrimination (using Coping with Discrimination Scale), internalized racism (with Appropriated Racial Oppression Scale) and resistance/empowerment towards racism (through Resistance and Empowerment Against Racism Scale)."

Answered by AI

Is enrollment ongoing for this experiment?

"Per the information found on clinicialtrials.gov, this research project is actively in search of participants. This trial was originally uploaded to the website on March 10th 2023 and underwent its latest edit two months later."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

The Impact of a Race-Based Stress Reduction Intervention

2023. "The Impact of a Race-Based Stress Reduction Intervention". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT05902741.