Cardiovascular Disease Risk Reduction, Chronic Stress, Anxiety, Emotional Regulation, Hypertension Prevention, Health Disparities
Conditions
Keywords
Heart Rate Variability, Biofeedback, Stress Reduction, Anxiety Management, Cardiovascular Health, Emotional Regulation, Preventative Health, Mind-Body Intervention
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.
Detailed 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.
Interventions
BEHAVIORALHRV Biofeedback Training
Participants will be trained to use HRV biofeedback through paced breathing exercises (6 breaths per minute) twice daily over a four-week period.
Sponsors
University of Puerto Rico
Amelia Saul, PhD, CTRS, BCB
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
SINGLE (Outcomes Assessor)
Intervention model description
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.
Eligibility
Sex/Gender
ALL
Age
18 Years to 35 Years
Healthy volunteers
Yes
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Heart Rate Variability Improvement | 4 weeks | HRV will be assessed using the OptimalHRV sensor to determine improvements in autonomic regulation and stress resilience. |
| State Anxiety Reduction (Beck Anxiety Inventory - BAI) | 4 weeks | 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. |
| Stress Resilience Under Acute Stress (Socially Evaluated Cold Pressor Test - SECPT) | 4 weeks | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Blood Pressure | 4 weeks | Change in systolic and diastolic blood pressure. |
| Galvanic Skin Response (GSR; Electrodermal Activity) | 4 weeks | Change in skin conductance level (SCL) and response frequency during stress and recovery tasks. |
Countries
United States
Contacts
Primary ContactAmelia D Saul, PhD
Outcome results
None listed