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Improving Minority Health Through Biofeedback and Stress Reduction

NCT07172152 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 66

Last updated 2026-05-08

No results posted yet for this study

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.

Conditions

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

Interventions

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.

Sponsors & Collaborators

  • University of Puerto Rico

    collaborator OTHER

  • Amelia Saul, PhD, CTRS, BCB

    lead OTHER

Principal Investigators

  • Amelia D Saul, PhD · Florida International University

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
35 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2025-09-15
Primary Completion
2025-12-01
Completion
2025-12-01

Countries

  • United States

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07172152 on ClinicalTrials.gov