Improving Minority Health Through Biofeedback and Stress Reduction

May 6, 2026 updated by: Amelia Saul, PhD, CTRS, BCB

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Actual)

66

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Florida
      • Miami, Florida, United States, 33199
        • Florida International University

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult

Accepts Healthy Volunteers

Yes

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: HRV Biofeedback Intervention Group

Participants in this group will receive HRV biofeedback training for four weeks. They will attend five sessions: an initial baseline session, three weekly check-in sessions, and a final post-intervention assessment.

HRV biofeedback training will utilize an app that will provide guidance to participants to follow a pacer and breathe for 10 minutes and feedback will be provided.
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.
Other Names:
  • HRVB
No Intervention: Control Group
Participants in this group will complete baseline and post-study assessments but will not receive the HRV biofeedback intervention. They will continue their usual daily activities without specific stress management training.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Heart Rate Variability Improvement
Time Frame: 4 weeks
HRV will be assessed using the OptimalHRV sensor to determine improvements in autonomic regulation and stress resilience.
4 weeks
Stress Resilience Under Acute Stress (Socially Evaluated Cold Pressor Test - SECPT)
Time Frame: 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.
4 weeks
State Anxiety Reduction (Beck Anxiety Inventory - BAI)
Time Frame: 4 weeks
Changes in self-reported state anxiety levels will be assessed before and after the HRV biofeedback intervention using the Beck Anxiety Inventory (BAI). The BAI is a 21-item self-report questionnaire designed to measure anxiety severity. Each item is scored on a 4-point Likert scale ranging from 0 ("Not at all") to 3 ("Severely-it bothered me a lot"), resulting in a total score ranging from 0 to 63. Higher scores indicate greater levels of anxiety, while lower scores indicate reduced anxiety.
4 weeks

Secondary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Amelia Saul, PhD, CTRS, BCB

Collaborators

University of Puerto Rico

Investigators

  • Principal Investigator: Amelia D Saul, PhD, Florida International University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

September 15, 2025

Primary Completion (Actual)

December 1, 2025

Study Completion (Actual)

December 1, 2025

Study Registration Dates

First Submitted

September 8, 2025

First Submitted That Met QC Criteria

September 8, 2025

First Posted (Actual)

September 15, 2025

Study Record Updates

Last Update Posted (Actual)

May 8, 2026

Last Update Submitted That Met QC Criteria

May 6, 2026

Last Verified

September 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • RB-23-0122-AM02

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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