Improving Minority Health Through Biofeedback and Stress Reduction

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

NA

Total Enrollment

64 participants

Study Classification

INTERVENTIONAL

Study Start Date

2025-09-15

Study Completion Date

2026-08-31

Brief Summary

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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.

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Detailed Description

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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.

Conditions

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

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

This study follows a randomized controlled trial (RCT) design with a parallel assignment of participants into two groups:

Intervention Group: Receives a four-week HRV biofeedback training. Control Group: No intervention, continues with usual activities.

Primary Study Purpose

PREVENTION

Blinding Strategy

SINGLE

Outcome Assessors

Study Groups

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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.

Group Type EXPERIMENTAL

HRV Biofeedback Training

Intervention Type BEHAVIORAL

Participants will be trained to use HRV biofeedback through paced breathing exercises (6 breaths per minute) twice daily over a four-week period.

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.

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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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.

Intervention Type BEHAVIORAL

Other Intervention Names

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HRVB

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Maximum Eligible Age

35 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes