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临床试验/NCT05115240
NCT05115240已完成不适用

The Effects of a Brief Mindfulness Intervention on Emotional Responses and the Moderating Role of Interoception

Philipps University Marburg2 个研究点 分布在 1 个国家目标入组 66 人开始时间: 2021年10月1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
66
试验地点
2
主要终点
Change in affect

研究概览

简要总结

This study examines the effects of a brief mindfulness intervention (body scan) on emotional responses (e.g., affect, heart rate variability (HRV)) compared to an active control group. Another aim is to assess whether the effects of the mindfulness intervention can be augmented by optimizing positive expectations. The moderating role of interception on the mindfulness intervention's effects will also be examined.

详细描述

This 3-armed study examines the effects of a brief mindfulness intervention (audio-guided body scan) on emotional responses (e.g., affect, and heart rate variability (HRV)) compared to an active control group (listening to an audio-book). Another aim is to assess whether the effects of the mindfulness intervention can be augmented by optimizing positive expectations. The moderating role of interception (i.e., interoceptive accuracy as assessed by the Schandry task) on the mindfulness intervention's effects will also be examined.

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
None

入排标准

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

入选标准

  • fluent in the German language
  • ability to give informed consent

排除标准

  • cardiovascular disease (previous myocardial infarction, hypertension)
  • neurological disorders (epilepsy, stroke, multiple sclerosis)
  • continuous medication intake (exceptions: contraceptives, nutritional supplements, L-thyroxine for hypothyroidism are allowed)
  • pregnancy

结局指标

主要结局

Change in affect

时间窗: Change from pre (baseline) to post scores (30 minutes later)

Participants are asked to rate adjectives regarding their current mood (positive and negative) at two time points (baseline and after body scan or active control intervention) on a questionnaire. Change scores are calculated (post- minus pre-scores). Instrument: Positive and Negative Affect Scale (PANAS) by Watson, Clark, and Tellegen (1988) is a self-report questionnaire that consists of two 10-item scales to measure both positive and negative affect. Each item is rated on a 5-point scale of 1 (not at all) to 5 (very much). Range for sum score of positive/negative affect: 10-50. For positive affect higher scores are better; for negative affect lower scores are better.

次要结局

  • Change in interoceptive accuracy(Change from pre (baseline) to post scores (30 minutes later))
  • Change in heart rate variability (HRV)(Change from pre (baseline) to post scores (30 minutes later))
  • Change in perceived stress(Change from pre (baseline) to post scores (30 minutes later))
  • Change in state anxiety and depression(Change from pre (baseline) to post scores (30 minutes later))

研究者

申办方类型
Other
责任方
Sponsor

研究点 (2)

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