Improving Minority Health Through Biofeedback and Stress Reduction

NCT07172152 | Completed

• 1 other identifier: RB-23-0122-AM02
• Study Type: interventional
• Target: 66
• Locations: 1 country
• Sites: 1

Brief 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

Keywords

Heart Rate Variability; Biofeedback; Stress Reduction; Anxiety Management; Cardiovascular Health; Emotional Regulation; Preventative Health; Mind-Body Intervention

Outcome Measures

Primary Outcomes (3)

• Heart Rate Variability Improvement

  HRV will be assessed using the OptimalHRV sensor to determine improvements in autonomic regulation and stress resilience.

  4 weeks

• State Anxiety Reduction (Beck Anxiety Inventory - BAI)

  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

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

  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

Secondary Outcomes (2)

• Blood Pressure

  4 weeks

• Galvanic Skin Response (GSR; Electrodermal Activity)

  4 weeks

Study Arms (2)

HRV Biofeedback Intervention Group

EXPERIMENTAL

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

Control Group

NO INTERVENTION

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.

Interventions

HRV Biofeedback Training BEHAVIORAL

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

Also known as: HRVB

HRV Biofeedback Intervention Group

Eligibility Criteria

• Age: 18 Years - 35 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• Adults
• Age 18 to 35 years
• Cognitively intact to follow instructions
• English-speaking
• Family history of cardiovascular disease.

You may not qualify if:

• 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

Sponsors & Collaborators

• Amelia Saul, PhD, CTRS, BCB: lead
• University of Puerto Rico: collaborator

Study Sites (1)

Florida International University

Miami, Florida, 33199, United States

Location

Related Publications (2)

• Shaffer F, Ginsberg JP. An Overview of Heart Rate Variability Metrics and Norms. Front Public Health. 2017 Sep 28;5:258. doi: 10.3389/fpubh.2017.00258. eCollection 2017.

  PMID: 29034226 RESULT

• Bolin LP, Saul AD, Bethune Scroggs LL, Horne C. A pilot study investigating the relationship between heart rate variability and blood pressure in young adults at risk for cardiovascular disease. Clin Hypertens. 2022 Jan 15;28(1):2. doi: 10.1186/s40885-021-00185-z.

  PMID: 35031077 RESULT

MeSH Terms

Conditions

Anxiety Disorders; Emotional Regulation

Condition Hierarchy (Ancestors)

Mental Disorders; Self-Control; Social Behavior; Behavior

Study Officials

• Amelia D Saul, PhD

  Florida International University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Assistant Teaching Professor

Model Details: 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.

Study Record Dates

• First Submitted: September 8, 2025
• First Posted: September 15, 2025
• Study Start: September 15, 2025
• Primary Completion: December 1, 2025
• Study Completion: December 1, 2025
• Last Updated: May 8, 2026

Record last verified: 2025-09

Locations

US (1)