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临床试验/NCT04125758
NCT04125758已完成不适用

Is Knowing the Body Knowing the Mind? Stress-physiology Coherence, Interoception, and Mindfulness

University of Wisconsin, Madison1 个研究点 分布在 1 个国家目标入组 120 人开始时间: 2020年1月21日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
已完成
入组人数
120
试验地点
1
主要终点
Change in subjective stress-heart rate coherence

研究概览

简要总结

Chronic stress has been shown to impact long-term emotional and physical health. When nearly three-quarters of Americans report stress at levels that exceed what they consider healthy, there is a desperate need to understand factors that contribute to effective stress regulation. This work seeks to develop a measure tied to awareness and acceptance of stress that has shown promise as a predictor of multiple markers of mental and physical well-being, understand how it relates to awareness of the body, and explore whether it can be trained to alleviate suffering and promote well-being. This study aims to 1) Conceptually replicate and extend previous findings linking greater stress-physiology coherence to higher well-being. 2) Assess whether awareness of physiology is associated with stress-physiology coherence. 3) Explore whether stress-physiology coherence can be trained through a brief mindfulness training intervention.

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
Double (Investigator, Outcomes Assessor)

盲法说明

Researchers involved in participant testing will not know the participant's group. Researchers conducting data analysis will not know data codes assigned to groups.

入排标准

年龄范围
18 Years 至 65 Years(Adult, Older Adult)
性别
All
接受健康志愿者
是

入选标准

  • •Age 18 to 65;
  • •Comfortable reading, writing, and conversing in English
  • •U.S. Citizen or permanent resident (for payment purposes)
  • •Have a smartphone compatible with our study app

排除标准

  • •Significant past experience with meditation, yoga, tai chi, or qi gong;
  • •Current or past psychotic disorder, Bipolar Disorder, PTSD, or social phobia;
  • •Current, severe major depressive episode;
  • •Current, severe generalized anxiety;
  • •Active prescription stimulant use (current or in the past month);
  • •Active prescription beta-blocker, beta-agonist, anti-high blood pressure, or anti-anxiety medication use (current or in the past month);
  • •Currently pregnant (due to physiological changes);
  • •History of neurological disorder;
  • •Currently diagnosed with high blood pressure, or heart murmur;
  • •Have a pacemaker
  • •Have participated in the Trier Social Stress Test previously

研究组 & 干预措施

Mindfulness training

Experimental

Participants will listen to one to two 3-30 minute audio recordings each day for 4 weeks between study visits (28 days total) through the Healthy Minds @Work smartphone app and record when they listen to each recording on a paper log. The app will also collect data on which recordings, when, and for how long participants listen.

干预措施: Mindfulness training (Behavioral)

Tracking time spent on mobile device

Active Comparator

Participants will record how much time they estimate they have spent on their phone in the past 24 hours, each day for 4 weeks (28 days total) between study visits.

干预措施: Tracking time spent on mobile device (Behavioral)

结局指标

主要结局

Change in subjective stress-heart rate coherence

时间窗: Baseline and post-test, separated by 4 weeks

Within-participant association between repeated measures of subjective stress (1-100 Visual Analog Scale rating) and heart rate over the course of a stress-induction paradigm. Stronger positive associations indicate higher stress-heart rate coherence.

次要结局

未报告次要终点

研究者

申办方类型
Other
责任方
Sponsor

研究点 (1)

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