Improving Minority Health Through Biofeedback and Stress Reduction

Not Applicable

Recruiting

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

• Registration Number: NCT07172152
• Lead Sponsor: Amelia Saul, PhD, CTRS, BCB

Brief 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.

Study Timeline

• Status Verified: 2025-09
• Study Start: 2025-09-01
• Study First Submitted: 2025-09-08
• Study First Submitted QC: 2025-09-08
• Last Update Submitted: 2025-09-12
• Study First Posted: 2025-09-15
• Last Update Posted: 2025-09-18
• Primary Completion: 2026-03
• Study Completion: 2026-08-01

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 64

Inclusion Criteria

• Adults
• Age 18 to 35 years
• Cognitively intact to follow instructions
• English-speaking
• Family history of cardiovascular disease.

Exclusion Criteria

• Cognitive impairments that inhibit understanding instruction
• Current diagnosis of hypertension that is controlled with prescribed medication
• Previously receiving biofeedback training
• Having a severe medical condition (e.g., pacemaker, cardiac arrhythmia, hypertension, diabetes)
• Being actively psychotic
• Having a neurological condition (e.g., Parkinson's disease) that would complicate the interpretation of physiological data
• Patients currently taking medications such as MAOIs, alpha/beta-blockers, or withdrawal or maintenance medications (e.g., Librium, methadone) are excluded due to their potential to affect the HRV data

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Heart Rate Variability Improvement	4 weeks	HRV will be assessed using the OptimalHRV sensor to determine improvements in autonomic regulation and stress resilience.
State Anxiety Reduction (Beck Anxiety Inventory - BAI)	4 weeks	Changes in self-reported state anxiety levels, as measured by the Beck Anxiety Inventory (BAI), will be assessed before and after the HRV biofeedback intervention.
Stress Resilience Under Acute Stress (Socially Evaluated Cold Pressor Test - SECPT)	4 weeks	The Socially Evaluated Cold Pressor Test (SECPT) will be used to measure changes in both self-reported and physiological stress responses to an acute stressor. Self-reported distress will be measured using a Visual Analog Scale, a 0-10 scale where 0 = no pain and 10 = worst possible pain. Higher scores indicate worse outcomes (greater distress). Emotional response will be measured using the Self-Assessment Manikin (SAM), which assesses valence, arousal, and dominance on a 5-point pictorial scale. Scores are coded such that higher valence = more positive affect, higher arousal = greater activation, and higher dominance = greater sense of control.

Secondary Outcome Measures

Name	Time	Method
Blood Pressure	4 weeks	Change in systolic and diastolic blood pressure.
Galvanic Skin Response (GSR; Electrodermal Activity)	4 weeks	Change in skin conductance level (SCL) and response frequency during stress and recovery tasks.

Trial Locations

Locations (1)

Florida International University; 🇺🇸 Miami, Florida, United States