NCT07172152

Improving Minority Health Through Biofeedback and Stress Reduction

• Status: Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 64 (estimated)
• Sponsor: Amelia Saul, PhD, CTRS, BCB · Academic / Other
• Sex: All
• Age: 18 Years – 35 Years
• Healthy volunteers: Accepted

Summary

This study aims to evaluate the effectiveness of a four-week heart rate variability (HRV) biofeedback intervention to improve physiological stress response, emotion regulation, and anxiety-related symptoms in young ethnic minority adults with a family history of cardiovascular disease (CVD). Participants will be randomly assigned to either an intervention group, where they will engage in guided paced breathing exercises, or a control group, which will follow standard conditions without the intervention. The study consists of five sessions, including an initial assessment, three weekly check-in sessions, and a final post-intervention assessment. Participants will practice paced breathing at home and attend brief in-lab sessions to track progress. Physiological and psychological measures, such as HRV, GSR, BP, anxiety levels, and responses to the Socially Evaluated Cold Pressor Test (SECPT), will be used to assess outcomes. Findings from this study may provide insights into accessible, non-invasive stress management interventions to mitigate CVD risk in high-risk populations.

Detailed description

Cardiovascular disease (CVD) is the leading cause of death in the United States, disproportionately affecting racial and ethnic minority populations. Chronic stress has been identified as a significant risk factor for CVD, yet few interventions address stress reduction as a preventative measure. This study investigates whether HRV biofeedback training can serve as an effective, non-pharmacological intervention to improve stress resilience and reduce risk factors associated with CVD.

Conditions

• Cardiovascular Disease Risk Reduction
• Chronic Stress
• Anxiety
• Emotional Regulation
• Hypertension Prevention
• Health Disparities

Interventions

Type	Name	Description
BEHAVIORAL	HRV Biofeedback Training	Participants will be trained to use HRV biofeedback through paced breathing exercises (6 breaths per minute) twice daily over a four-week period.

Timeline

• Start date: 2025-09-15
• Primary completion: 2026-03-01
• Completion: 2026-08-01
• First posted: 2025-09-15
• Last updated: 2025-10-20

Locations

1 site across 1 country: United States