RECRUITING

Improving Minority Health Through Biofeedback and Stress Reduction

Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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.

Official Title

Improving Minority Health Through Biofeedback and Stress Reduction

Quick Facts

Study Start:2025-09
Study Completion:2026-08
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT07172152

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.

Ages Eligible for Study:18 Years to 35 Years
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:Yes
Standard Ages:ADULT
Inclusion CriteriaExclusion Criteria
  1. * Adults
  2. * Age 18 to 35 years
  3. * Cognitively intact to follow instructions
  4. * English-speaking
  5. * Family history of cardiovascular disease.
  1. * Cognitive impairments that inhibit understanding instruction
  2. * Current diagnosis of hypertension that is controlled with prescribed medication
  3. * Previously receiving biofeedback training
  4. * Having a severe medical condition (e.g., pacemaker, cardiac arrhythmia, hypertension, diabetes)
  5. * Being actively psychotic
  6. * Having a neurological condition (e.g., Parkinson's disease) that would complicate the interpretation of physiological data
  7. * 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

Contacts and Locations

Study Contact

Amelia D Saul, PhD
CONTACT
3053483472
asaul@fiu.edu

Principal Investigator

Amelia D Saul, PhD
PRINCIPAL_INVESTIGATOR
Florida International University

Study Locations (Sites)

Florida International University
Miami, Florida, 33199
United States

Collaborators and Investigators

Sponsor: Amelia Saul, PhD, CTRS, BCB

  • Amelia D Saul, PhD, PRINCIPAL_INVESTIGATOR, Florida International University

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 Registration Dates

Study Start Date2025-09
Study Completion Date2026-08

Study Record Updates

Study Start Date2025-09
Study Completion Date2026-08

Terms related to this study

Keywords Provided by Researchers

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

Additional Relevant MeSH Terms

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