CompletedNot Applicable

Improving Minority Health Through Biofeedback and Stress Reduction

United States66 participantsStarted 2025-09-15

Plain-language 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.

Who can participate

Age range

18 Years – 35 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Heart Rate Variability Improvement

Timeframe: 4 weeks

State Anxiety Reduction (Beck Anxiety Inventory - BAI)

Timeframe: 4 weeks

Stress Resilience Under Acute Stress (Socially Evaluated Cold Pressor Test - SECPT)

Timeframe: 4 weeks

Trial details

NCT IDNCT07172152

SponsorAmelia Saul, PhD, CTRS, BCB

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2025-12-01

View on ClinicalTrials.gov More Cardiovascular Disease Risk Reduction trials

Plain-language summary

Who can participate

Age range

18 Years – 35 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.