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临床试验/NCT04258540
NCT04258540已完成不适用

The Effects of Yoga on Student Mental Health: A Randomised Controlled Trial

University of Oslo1 个研究点 分布在 1 个国家目标入组 202 人开始时间: 2016年12月16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
202
试验地点
1
主要终点
Change in Psychological Distress

研究概览

简要总结

The investigators performed a randomised controlled trial with 202 healthy university students in the Oslo area, with 50:50 in a yoga intervention group and a waitlist control group. Measures included symptoms of depression and anxiety, sleep problems, heart rate variability (HRV), well-being and mindfulness at week 0 (baseline), week 12 (post-intervention) and week 24 (follow-up).

详细描述

Universities around the world are facing an epidemic of mental health problems among their students. The problem is truly a public health issue, affecting many and with serious consequences. Moreover, the global burden of disease-agenda calls for effective interventions with lasting effects that have the potential to improve the mental health of young adults. In this study the investigators aimed to determine whether yoga, a popular and widely available mind-body practice, can improve student mental health.

The participants were randomly assigned to a yoga group or waitlist control group in a 1:1 ratio by a simple online randomisation program. The intervention group was offered 24 yoga sessions over 12 weeks. Measurements were taken at week 0 (baseline), week 12 (post-intervention), and week 24 (follow-up). The primary outcome was psychological distress assessed by the HSCL-25 questionnaire. Analysis was performed based on the intention to treat-principle.

The methods were laid out in a protocol, previously published on the website of the study. (available at http://yogastudy.tilda.ws/). The planned analyses were very straightforward and included a description of the study participants, and simple analyses of each of the a priori selected outcome measures. We have not included or excluded any variables post-hoc.

研究设计

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

盲法说明

Randomisation by a simple online program.

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

  • Living in the Oslo area

排除标准

  • No serious mental health diagnoses
  • No recent major life crisis
  • No systematic yoga practice during the prior six months

结局指标

主要结局

Change in Psychological Distress

时间窗: Week 0 (baseline), week 12 (post-intervention) and week 24 (follow-up)

Measured with the Hopkins Symptom Checklist 25 (HSCL-25) questionnaire. Consists of 25 items on symptoms of depression and anxiety, each rated on a 1 (not at all) to 4 (very much) scale. Total scores range from 1 to 4, a higher score indicating more psychological distress.

次要结局

  • Change in Heart Rate Variability (HRV)(Week 0 (baseline) and week 12 (post-intervention))
  • Change in Mental Well-being(Week 0 (baseline), week 12 (post-intervention) and week 24 (follow-up).)
  • Change in Mindfulness(Week 0 (baseline), week 12 (post-intervention) and week 24 (follow-up).)
  • Change in Life Satisfaction(week 0 (baseline), week 12 (post-intervention) and week 24 (follow-up).)
  • Change in Sleep Problems(Week 0 (baseline), week 12 (post-intervention) and week 24 (follow-up).)

研究者

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

Tiril Elstad

Principal Investigator

University of Oslo

研究点 (1)

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The Effects of Yoga on Student Mental Health | 临床试验