Improving Minority Health Through Biofeedback and Stress Reduction
Completed · Not applicable
Conditions studied: Cardiovascular Disease Risk Reduction, Chronic Stress, Anxiety, Emotional Regulation, Hypertension Prevention, Health Disparities
In brief
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.
Key facts
- Study ID
- NCT07172152
- Run by
- Amelia Saul, PhD, CTRS, BCB
- People needed
- 66
- Starts
- 2025-09-15
- Expected to finish
- 2025-12-01
- Last updated by the study team
- 2026-05-08
Who can join
Age: 18 and older, up to 35. Sex: any. Healthy volunteers: accepted.
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
Where it is running
- Florida International University — Miami, Florida, United States
Full record on ClinicalTrials.gov
Trial information comes from ClinicalTrials.gov and is refreshed daily. TrialsForMe does not provide medical care and does not run the studies it lists.