What side effects are associated with this type of intervention?

Cognitive-behavioral therapy (CBT), used to manage stress and inflammation, generally has minimal side effects, such as temporary increases in anxiety or emotional discomfort. In contrast, pharmacological treatments for inflammation, like steroids, can cause hyperglycemia, increased infection risk, bone loss, and neuropsychiatric effects. Mood stabilizers may lead to tremor, increased drinking, diarrhea, and subclinical hypothyroidism.

What prior FDA approvals exist?

The FDA has approved several biologic drugs for the treatment of inflammation, particularly in conditions like psoriasis and rheumatoid arthritis. Notable examples include secukinumab, an IL-17A antagonist, and risankizumab, which targets IL-23. These drugs help reduce inflammation by modulating the immune response. While the RiSE Program focuses on cognitive-behavioral strategies to reduce social stress and empower individuals, these biologic treatments represent a pharmacological approach to managing inflammation.

What other types of research exist?

Promising alternatives to the RiSE Program for inflammation patients include: 1) Mind-Body Therapies such as yoga and Qigong massage, which have shown benefits in stress reduction and overall well-being. 2) Cognitive Behavioral Therapy for Insomnia (CBT-I), which has demonstrated improvements in psychological well-being and sleep-related quality of life. 3) Guided Imagery and Progressive Muscle Relaxation, which have been effective in managing pain and stress in various patient populations. These alternatives offer holistic approaches that can complement traditional medical treatments for inflammation.

← Back to Search

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

No Placebo-Only Group

Summary

This trial tests if the RiSE program, a short online stress reduction course, can improve well-being and health in African American women at risk for heart or other health issues. The program teaches techniques to manage social stress and promote empowerment. The RiSE program is a short group-based stress reduction program designed to help Black women at risk for heart disease develop effective coping skills for dealing with chronic stress uniquely associated with being a minority.

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.

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.

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

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Current perceived stress

Secondary study objectives

Anxiety

Coping with discrimination

DNA methylation

+12 more

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

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: 1. processing and sharing experiences related to race based stress, 2. psychoeducation on the biopsychosocial impact of racism, 3. skill building and empowerment.

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

Health Education Program

Do I qualify?Apply below to find out

Research Highlights

Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.

Mechanism Of Action

Side Effect Profile

Prior Approvals

Other Research

Cognitive-behavioral strategies reduce inflammation by altering thought patterns and behaviors to lower stress and improve emotional regulation. This leads to decreased levels of pro-inflammatory cytokines. Empowerment and racial identity development, as emphasized in the RiSE Program, further enhance these effects by improving self-esteem and reducing the physiological impact of social stressors like racism. This is crucial for inflammation patients as chronic stress and inflammation are closely linked, and reducing stress can significantly improve inflammatory conditions and overall well-being.