Improving Minority Health Through Biofeedback and Stress Reduction

NCT07172152 · Florida International University

Recruiting

In plain English

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About this study

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.

Eligibility criteria

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

Enrollment target: 64 participants

Allocation: randomized

Masking: single

Age groups: adult

Timeline

Starts: 2025-09-15

Estimated completion: 2026-08

Last updated: 2025-10-20

Interventions

Behavioral: HRV Biofeedback Training

Primary outcomes

• Heart Rate Variability Improvement (4 weeks)
• State Anxiety Reduction (Beck Anxiety Inventory - BAI) (4 weeks)
• Stress Resilience Under Acute Stress (Socially Evaluated Cold Pressor Test - SECPT) (4 weeks)

Sponsor

Amelia Saul, PhD, CTRS, BCB · other

With: University of Puerto Rico

Contacts & investigators

ContactAmelia D Saul, PhD · contact · asaul@fiu.edu · 3053483472

InvestigatorAmelia D Saul, PhD · principal_investigator, Florida International University

All locations (1)

Florida International UniversityRecruiting

Miami, Florida, United States

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