Improving Minority Health Through Biofeedback and Stress Reduction

Status: Recruiting
Location: See location...
Intervention Type: Behavioral
Study Type: Interventional
Study Phase: Not Applicable
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.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Maximum Age: 35
Healthy Volunteers: t
View:

• Adults

• Age 18 to 35 years

• Cognitively intact to follow instructions

• English-speaking

• Family history of cardiovascular disease.

Locations
United States
Florida
Florida International University
RECRUITING
Miami
Contact Information
Primary
Amelia D Saul, PhD
asaul@fiu.edu
3053483472
Time Frame
Start Date: 2025-09
Estimated Completion Date: 2026-08
Participants
Target number of participants: 64
Treatments
Experimental: 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.
No_intervention: 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.
Related Therapeutic Areas
Sponsors
Leads: Amelia Saul, PhD, CTRS, BCB
Collaborators: University of Puerto Rico

This content was sourced from clinicaltrials.gov