Improving Minority Health Through Biofeedback and Stress Reduction
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 66
- 试验地点
- 1
- 主要终点
- Heart Rate Variability Improvement
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- Single (Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 35 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Age 18 to 35 years
- •Cognitively intact to follow instructions
- •English-speaking
- •Family history of cardiovascular disease.
排除标准
- •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
研究组 & 干预措施
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.
干预措施: HRV Biofeedback Training (Behavioral)
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.
结局指标
主要结局
Heart Rate Variability Improvement
时间窗: 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)
时间窗: 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)
时间窗: 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.
Heart Rate Variability Improvement
时间窗: 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)
时间窗: 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)
时间窗: 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.
次要结局
- Blood Pressure(4 weeks)
- Galvanic Skin Response (GSR; Electrodermal Activity)(4 weeks)
研究者
Amelia Saul, PhD, CTRS, BCB
Assistant Teaching Professor
Florida International University