Examining the Interactive Effects of Mindfulness and Slow-paced Breathing on Stress Physiology: A Pilot Study
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 19
- 试验地点
- 2
- 主要终点
- Breathing rate
研究概览
简要总结
The purpose of this study is to better understand specific stress-management practices on mood, sleep, and physiology. Participants will be assigned to one of three interventions (they all active interventions - none are a "wait-list"). Each intervention asks participants to engage in a daily practice of 20 minutes per day for 8 weeks. Questionnaires and measures of heart rate and blood pressure will be collected at the start and end of the 8 weeks, including a virtual laboratory visit.
详细描述
Slow-paced breathing (SPB), mindfulness (M), and their combination (SPB+M) in the form of yoga, yogic breathing, Tai Chi, Qigong, and other practices are considered distinct forms of intervention, yet are often considered inextricably linked and overlapping in their effects on the autonomic nervous system. Although the scientific community continues to build understanding of autonomic mechanisms that might be unique to SPB, M, and their interaction (SPB+M), no studies we are aware of have attempted to directly compare these three forms of intervention in a controlled fashion that enables a 'dismantling' framework of interpretation.
The goal of this pilot project is to compare the separate and combined effects of SPB and M on autonomic function. We will test the feasibility of a three-arm intervention trial (N=5 per group), involving 20-min daily practice for 8 weeks, with multimodal ambulatory autonomic measurement before and after intervention. We will first focus on a healthy young adult population to then inform translation to hypertension, insomnia, and other clinical groups.
Aim 1: Distinguish SPB, M, and SPB+M training in terms of breathing rate and subjective mindfulness.
Aim 2: Obtain pilot data comparing the three interventions in terms of autonomic regulation using both conventional metrics and non-linear dynamics.
Aim 3: Develop methods to examine relationships across domains of autonomic regulation, stress, and sleep for the three interventions.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Basic Science
- 盲法
- Single (Participant)
入排标准
- 年龄范围
- 18 Years 至 24 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Age 18-24 years.
排除标准
- •Active infection/disease
- •Current untreated mental or physical health condition deemed likely to interfere with ability to complete study procedures (determined by study staff consensus)
- •Current use of medications with known effects on stress physiology (antidepressants [SSRI, SNSI, NDRI, atypical, TCA, MAOI], anitpsychotics, benzodiazepines, non-benzodiazepine receptor agonists, melatonin and melatonin receptor agonists, orexin/hypocretin receptor antagonists, barbiturates, mood stabilizers, anticonvulsants, anticholinergics, first generation antihistamines, and stimulants including NRI, antihypertensives, opioids, or systemic corticosteroids)
- •Moderate/substantial prior meditation, yoga, or other mind-body practice self-reported as a self-rating of 5 or higher on a scale of 0-10 asking "How experienced are you with meditation, yoga, or other mind-body interventions?"
结局指标
主要结局
Breathing rate
时间窗: 8-weeks (post-intervention), 15 minute practice session during the virtual laboratory visit
Participants will wear a Polar H10 chest strap heart rate monitor during training and daily practice, and breathing rate will be derived from the HR interbeat interval series. We expect participants randomized to SPB and SPB+M to show slower breathing rates compared to M during a recorded practice session at 8-weeks.
Five Facet Mindfulness Questionnaire (FFMQ)
时间窗: 8-weeks (post-intervention) completed electronically prior to virtual laboratory visit
We expect M and SPB+M to more highly report qualities of experience consistent with mindfulness. Primary outcome will focus on total score, summing across the five facets (total score range: 39-195; higher scores reflect higher mindfulness ratings).
次要结局
- Systolic blood pressure(8-weeks (post-intervention), stress induction task (Stroop test) during the virtual laboratory visit)
- Heart rate variability (normalized high-frequency power, HFnu)(8-weeks (post-intervention), stress induction task (Stroop test) during the virtual laboratory visit)
研究者
Michael R. Goldstein
Research Fellow
Beth Israel Deaconess Medical Center