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临床试验/NCT04382560
NCT04382560已完成不适用

Resting Heart Rate Variability as a Predictor of Coping Strategies and Responsiveness to a Brief Online Intervention During Forced Quarantine

University of Parma2 个研究点 分布在 1 个国家目标入组 69 人开始时间: 2020年5月2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
69
试验地点
2
主要终点
Dispositional questionnaire 1

研究概览

简要总结

The present study investigates the efficacy of a brief and cost-effective video-intervention that combines bottom-up elements of deep breathing and third-wave cognitive behavioral therapy techniques (i.e., mindfulness and compassion) on coping strategies during the COVID-19 pandemic.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Other
盲法
Double (Investigator, Outcomes Assessor)

入排标准

年龄范围
20 Years 至 50 Years(Adult)
性别
All
接受健康志愿者

入选标准

  • Being healthy
  • Previous participation (maximum elapsed time: 2.0 years) in a study conducted by the same research group and incorporating cardiac autonomic assessment at rest

排除标准

  • Self-reported development of cardiovascular disease since previous assessment
  • Use of psychotropic medications or medications affecting the autonomic nervous system

结局指标

主要结局

Dispositional questionnaire 1

时间窗: During waking hours for two consecutive days after the intervention/control condition

Perseverative cognition measured as frequency score. Minimum score = 0 Maximum score = 28. Higher scores mean a worse outcome.

Dispositional questionnaire 3

时间窗: During waking hours for two consecutive days after the intervention/control condition

Mood state measured as score on a Likert scale. Minimum score = 1 Maximum score = 5. Higher scores mean a worse outcome.

Dispositional questionnaire 2

时间窗: During waking hours for two consecutive days after the intervention/control condition

Effective coping strategies measured as frequency score. Minimum score = 0 Maximum score = 28. Higher scores mean a better outcome.

Dispositional questionnaire 4

时间窗: During waking hours for two consecutive days after the intervention/control condition

Emotional state measured as score on a Likert scale. Minimum score = 1 Maximum score = 5. Higher scores mean a worse outcome.

次要结局

  • Heart rate(During waking hours for two consecutive days after the intervention/control condition)
  • Cardiac vagal modulation(During waking hours for two consecutive days after the intervention/control condition)

研究者

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

Luca Carnevali

PhD

University of Parma

研究点 (2)

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