Status:
RECRUITING
Improving Minority Health Through Biofeedback and Stress Reduction
Lead Sponsor:
Amelia Saul, PhD, CTRS, BCB
Collaborating Sponsors:
University of Puerto Rico
Conditions:
Cardiovascular Disease Risk Reduction
Chronic Stress
Eligibility:
All Genders
18-35 years
Phase:
NA
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 sym...
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 significan...
Eligibility Criteria
Inclusion
- Adults
- Age 18 to 35 years
- Cognitively intact to follow instructions
- English-speaking
- Family history of cardiovascular disease.
Exclusion
- 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
Key Trial Info
Start Date :
September 15 2025
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
August 1 2026
Estimated Enrollment :
64 Patients enrolled
Trial Details
Trial ID
NCT07172152
Start Date
September 15 2025
End Date
August 1 2026
Last Update
October 17 2025
Active Locations (1)
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1
Florida International University
Miami, Florida, United States, 33199