A Randomized Controlled Trial of Heart Rate Variability Biofeedback Following Traumatic Brain Injury
试验速览
- 阶段
- 早期 1 期
- 状态
- 招募中
- 入组人数
- 50
- 试验地点
- 2
- 主要终点
- Resting HRV
研究概览
简要总结
Individuals with mild traumatic brain injury will be randomly assigned to an active heart rate variability biofeedback condition and a sham condition. The investigators will use a randomized pre-post design that will consist of two data collection phases and a 5-week treatment condition. The heart rate variability biofeedback active condition is designed to increase heart rate oscillations (Osc+ condition) consistent with current best practices, while the sham control heart rate variability biofeedback condition is designed to decrease heart rate oscillations (Osc- condition).
详细描述
There are two primary aims of the study: (1) examine whether heart rate variability increases at rest in individuals with mild traumatic brain injury from pre-treatment to post-treatment following heart rate variability biofeedback; (2) to test whether heart rate variability recovery following a stressor improves in individuals with mild traumatic brain injury following heart rate variability biofeedback. Regarding the first primary aim, the investigators hypothesize that heart rate variability will be higher in individuals with mild traumatic brain injury following heart rate variability biofeedback compared to those in the control/sham condition where the investigators do not expect such improvement pre- to post-testing. For the second aim, consistent with previous work, the investigators hypothesize that heart rate variability recovery following a stressor will be faster in individuals with mild traumatic brain injury following heart rate variability biofeedback compared to a sham control condition. There are three secondary aims for this study: (1) to evaluate whether improvements in heart rate variability in individuals with mild traumatic brain injury following heart rate variability biofeedback are associated with improvements in physical symptoms common after head injury (i.e., headaches, dizziness, sleep disturbance); (2) to evaluate whether improvements in heart rate variability in individuals with mild traumatic brain injury following heart rate variability biofeedback are associated with improvements in emotional functioning (i.e., life satisfaction, anxiety symptoms, depression symptoms); and (3) to evaluate whether improvements in heart rate variability in individuals with mild traumatic brain injury following heart rate variability biofeedback are associated with improvements in cognitive functioning (i.e., attention, inhibitory control).
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Double (Participant, Outcomes Assessor)
盲法说明
Baseline measurements will be collected by undergraduate research assistants blinded to group conditions to reduce possible experimenter bias effects. Additionally, research assistants will be blinded to conditions for all testing sessions.
入排标准
- 年龄范围
- 18 Years 至 55 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •At least six months post-injury to account for spontaneous recovery
- •Aged 18-55 years
- •Fluent in English
- •Able to provide informed consent.
排除标准
- •Presence of a pacemaker
- •Previous self-reported heart attack with hospitalization
- •Diagnosed learning disability
- •Other neurological difficulties or diagnoses (i.e., stroke, epilepsy)
- •Participation in current litigation
- •Uncorrected visual impairment.
结局指标
主要结局
Resting HRV
时间窗: Through study completion, an average of 7 weeks
Examine whether heart rate variability increases at rest in individuals with mild traumatic brain injury from pre-treatment to post-treatment following heart rate variability biofeedback
Stress Recovery
时间窗: Through study completion, an average of 7 weeks
Test whether heart rate variability recovery following a stressor improves in individuals with mild traumatic brain injury following heart rate variability biofeedback
次要结局
- Physical Symptoms(Through study completion, an average of 7 weeks)
- Depression Anxiety Stress Scales(Through study completion, an average of 7 weeks)
- Scale of Positive and Negative Experience(Through study completion, an average of 7 weeks)
- Cognitive Functioning(Through study completion, an average of 7 weeks)
- Satisfaction with Life Scale(Through study completion, an average of 7 weeks)
研究者
Leah Talbert
Principal Investigator
Brigham Young University