RecruitingNot ApplicableNCT07172152

Improving Minority Health Through Biofeedback and Stress Reduction


Sponsor

Amelia Saul, PhD, CTRS, BCB

Enrollment

64 participants

Start Date

Sep 15, 2025

Study Type

INTERVENTIONAL

Conditions

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.


Eligibility

Min Age: 18 YearsMax Age: 35 Years

Inclusion Criteria5

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

Exclusion Criteria7

  • 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

Interventions

BEHAVIORALHRV 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.


Locations(1)

Florida International University

Miami, Florida, United States

View Full Details on ClinicalTrials.gov

For the most up-to-date information, visit the official listing.

Visit

NCT07172152


Related Trials