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临床试验/NCT03296007
NCT03296007已完成不适用

Evaluating the Psychophysiological Effects of a Smartphone-Based Mindfulness Task on Individuals With Clinically Significant Symptoms of Chronic Pain, Depression and Anxiety

York University2 个研究点 分布在 1 个国家目标入组 2,016 人开始时间: 2017年11月10日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
2,016
试验地点
2
主要终点
Heart Rate Variability

研究概览

简要总结

The aim of the present study is to evaluate the psychophysiological effects of a smart phone based mindfulness meditation app (MMA) for individuals with clinically significant symptoms of major depression and/or anxiety, or symptoms of chronic pain. Specifically, the study aims to examine parasympathetic tone using HRV (primary outcome), mind-wandering and present awareness, mood symptoms, and breath focus in groups of participants who self-report clinically significant symptoms of depression and/or anxiety (DA), chronic pain symptoms (CP), as well as control participants who do not meet our criteria for either (Controls (C). All study groups will be randomized to a mindfulness meditation app (MMA+) condition or a mindfulness meditation condition without the app (MMA-) after a brief stress-induction procedure.

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
None

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

入选标准

  • York University students

排除标准

  • Individuals with diagnosed cardiac conditions (e.g. coronary artery disease, arrhythmias etc) will be excluded due to confounds with heart rate variability assessment

结局指标

主要结局

Heart Rate Variability

时间窗: 22 minutes

A stress biomarker derived from heart rate recordings that reflects parasympathetic control of cardiac output

次要结局

未报告次要终点

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Joel Katz

Professor

York University

研究点 (2)

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