Improving Minority Health Through Biofeedback and Stress Reduction

Amelia Saul, PhD, CTRS, BCB

Status: Enrolling

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

Treatments: Behavioral: HRV Biofeedback Training

Study type: Interventional

Funder types: Other

Identifiers

NCT07172152

RB-23-0122-AM02

Details and patient eligibility

About

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.

Full 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.

Enrollment: 64 estimated patients

Sex: All

Ages: 18 to 35 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

---

64 participants in 2 patient groups

HRV Biofeedback Intervention Group

Experimental group

Description:

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.

Treatment:

Behavioral: HRV Biofeedback Training

Control Group

No Intervention group

Description:

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.