MIndfulness for Students (Mindfulstud)
2018年9月11日 更新者：Saara Repo、University of Helsinki
Mindfulness for Students
The aim of the study is to find out, weather the students' wellbeing and functional ability can be enhanced by two different type of mindfulness interventions: 1) face-to-face group-based training, and 2) internet-based training based in mindfulness and acceptance and commitment therapy.
Study results may be used to decide whether it is worth offering mindfulness training for medical faculty students, and what kind of training would be most suitable and effective in the medical education context.
研究概览
地位
未知
详细说明
The hypotheses is that participating to the mindfulness intervention improves students well-being and decreases their level of stress. These are measured by self-evaluation questionnaires and with hair samples, before the intervention, immediately after intervention and four months after the intervention.
This is a randomized control trial. There are two different experiment groups and one waiting-list control group. The target group is all undergraduate students in the Faculty of Medicine, University of Helsinki. The participants are recruited with e-mail and informing students in different situations. The aimed amount of participants is 120-150 but the study will be conducted if 90 participants are recruited. The participants enroll to the study by signing consent format.
This is a follow-up research. The person register (name, university e-mail address, student number) are used to recruitment and to ensure the participants identity.
Time of data preservation is 10 years. The last student register data is going to be collected 2019. The data is preserved until age 2029.
The questionnaire with which the main data is been collected is Webropol questionnaire tool. The data is removed from the Webropol after three months of the end of the questionnaire answer time. The person responsible for the data removes the data from University's server after ten years.
Content of the register
- Mindfulness for Students questionnaire data
- Mindfulness for Students hair samples
- Mindfulness for students -observation log
- Mindfulness for students -interview data
- Data collected in Student Compass -internet environment
- Data of students' credits are collected from University's own credit register "Oodi", if participant has given a consent to that.
Students are being recruited in information meeting. They will be informed orally in that situation and given a written communication paper. The students who want to participate the course, will fill and sign a consent format. In format there is a research number code given to the student. The connection between the student identity and the research code number is known only by the persons that are responsible for the database.
研究类型
介入性
注册 (预期的)
120
阶段
- 不适用
联系人和位置
本节提供了进行研究的人员的详细联系信息，以及有关进行该研究的地点的信息。
学习地点
-
-
University Of Helsinki
-
Helsinki、University Of Helsinki、芬兰、00014
- 招聘中
- University of Helsinki
-
接触：
- Saara Repo, PhD
- 电话号码：+358405189456
- 邮箱：saara.repo@helsinki.fi
-
接触：
- Tiina Paunio, PhD
- 电话号码：+358947163734
- 邮箱：tiina.paunio@helsinki.fi
-
首席研究员：
- Saara Repo, PhD
-
-
参与标准
研究人员寻找符合特定描述的人，称为资格标准。这些标准的一些例子是一个人的一般健康状况或先前的治疗。
资格标准
适合学习的年龄
- 孩子
- 成人
- 年长者
接受健康志愿者
是的
有资格学习的性别
全部
描述
Inclusion Criteria:
- All undergraduate students of Faculty of Medicine, University of Helsinki who have started their studies in year 2009 or after that.
Exclusion Criteria:
- The participants that can not participate fully to the intervention (self-evaluated).
- Participants who have severe mental problems (like anxiety or depression) when the study starts,
- Participants who have hade a great loss or trauma in near past, or some other mental or physical health problem that could make participation difficult.
This is evaluated based on how the participants answers to the base line questionnaire the following measures:
- answers to the CORE-OM questionnaire and
- answers to the questions where participants evaluate themselves their anxiety, depression, mental health.
- If participant tell they have some other mental disorder, they are not accepted to the study.
学习计划
本节提供研究计划的详细信息，包括研究的设计方式和研究的衡量标准。
研究是如何设计的？
设计细节
- 主要用途：治疗
- 分配：随机化
- 介入模型：并行分配
- 屏蔽：双倍的
武器和干预
参与者组/臂 |
干预/治疗 |
|---|---|
|
实验性的：Face-to-face group-based mindfulness
8 weeks training.
|
An eight-week course, including 75-90 minutes once-a-week meeting.
Participants are supposed to practice mindfulness skills in their spare time 10-30 minutes per day.
An eight-week course, including 75-90 minutes once-a-week meeting.
Participants are supposed to practice mindfulness skills in their spare time 10-30 minutes per day.
This training is based on Jon Kabat-Zinn's course Mindfulness Based Stress Reduction and book Williams & Penman Mindfulness: a practical guide to finding peace in a frantic world and adapted for university students.
In addition, a manual written in Cambridge University "Mindfulness Skills for Students" is utilized.
|
|
实验性的：Internet-based mindfulness
8 weeks training.
|
An eight-week course, including 60 minutes starting and ending meeting.
Participants are practicing mindfulness, doing other tasks (writing, reading, reflecting) on their own.
This course is created in University of Jyväskylä, Finland.
It is based on mindfulness and Acceptance and Commmitment Therapy.
|
|
无干预：Waiting-list control group
No training during the study.
|
研究衡量的是什么？
主要结果指标
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
|
Change from Baseline CORE-OM measure at post-intervention and 4-month follow-up.
大体时间：It is measured three weeks before the intervention starts, immediately after the 8-week intervention is finished, and 4-month after the intervention is finished.
|
CORE-OM, Clinical Outcomes in Routine Evaluation Outcome Measure.
|
It is measured three weeks before the intervention starts, immediately after the 8-week intervention is finished, and 4-month after the intervention is finished.
|
次要结果测量
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
|
Change from Baseline rate of stress at post-intervention and 4-month follow-up.
大体时间：It is measured in the same day when the intervention starts, immediately after the 8-week intervention is finished, and 4-month after the intervention is finished.
|
Cortisol as an indicator of stress which is measured from hair samples.
Stadler & Kirschbaum 2012.
|
It is measured in the same day when the intervention starts, immediately after the 8-week intervention is finished, and 4-month after the intervention is finished.
|
|
Change from Baseline rate of resilience in studies at post-intervention and 4-month follow-up.
大体时间：It is measured three weeks before the intervention starts, immediately after the 8-week intervention is finished, and 4-month after the intervention is finished.
|
Workplace Acceptance and Action Questionnaire (WAAQ) applied for students.
Bond, Joda, and Guenole 2013; Asikainen, Hailikari, Mattson 2017.
|
It is measured three weeks before the intervention starts, immediately after the 8-week intervention is finished, and 4-month after the intervention is finished.
|
|
Change from Baseline rate of social support in studies at post-intervention and 4-month follow-up.
大体时间：It is measured three weeks before the intervention starts, immediately after the 8-week intervention is finished, and 4-month after the intervention is finished.
|
Application of questionnaires of social support from Sarason et al. 1987 and Pyörälä et al. 2015.
|
It is measured three weeks before the intervention starts, immediately after the 8-week intervention is finished, and 4-month after the intervention is finished.
|
|
Change from Baseline rate of study load in studies at post-intervention and 4-month follow-up.
大体时间：It is measured three weeks before the intervention starts, immediately after the 8-week intervention is finished, and 4-month after the intervention is finished.
|
Application of questionnaire of healthy work measure of Karasek & Theorell 1990.
|
It is measured three weeks before the intervention starts, immediately after the 8-week intervention is finished, and 4-month after the intervention is finished.
|
|
Students' possibilities to influence to their own studies
大体时间：It is measured three weeks before the interventions start.
|
Application of measures of healthy work measure.
Karasek & Theorell 1990.
|
It is measured three weeks before the interventions start.
|
|
Change from Baseline rate of functional ability in studies at post-intervention and 4-month follow-up.
大体时间：It is measured three weeks before the intervention starts, immediately after the 8-week intervention is finished, and 4-month after the intervention is finished.
|
Application of functional ability at work.
Tuomi et al. 1998.
|
It is measured three weeks before the intervention starts, immediately after the 8-week intervention is finished, and 4-month after the intervention is finished.
|
|
Change from Baseline rate of subjective experience of quality of life at post-intervention and 4-month follow-up.
大体时间：It is measured three weeks before the intervention starts, immediately after the 8-week intervention is finished, and 4-month after the intervention is finished.
|
Subjective experience of quality of life.
One Likert-scale question adapted and modified from three different questionnaires.
Koivumaa et al. 2000; Allardt 1973; Lundqvist & Mäkiopas 2016)
|
It is measured three weeks before the intervention starts, immediately after the 8-week intervention is finished, and 4-month after the intervention is finished.
|
|
Change from Baseline rate of mental well-being Scale at post-intervention and 4-month follow-up.
大体时间：It is measured three weeks before the intervention starts, immediately after the 8-week intervention is finished, and 4-month after the intervention is finished.
|
The Warwick-Edinburgh Mental Well-being Scale
|
It is measured three weeks before the intervention starts, immediately after the 8-week intervention is finished, and 4-month after the intervention is finished.
|
|
Change from Baseline rate of Personality at post-intervention and 4-month follow-up.
大体时间：It is measured three weeks before the intervention starts, immediately after the 8-week intervention is finished, and 4-month after the intervention is finished.
|
Parts of Big Five (Lang et al. 2011)
|
It is measured three weeks before the intervention starts, immediately after the 8-week intervention is finished, and 4-month after the intervention is finished.
|
|
Change from Baseline rate of sense of coherence at post-intervention and 4-month follow-up.
大体时间：It is measured three weeks before the intervention starts, immediately after the 8-week intervention is finished, and 4-month after the intervention is finished.
|
Sence of coherence - SOC 3 (Antonovsky 1987; Schumann et al. 2003)
|
It is measured three weeks before the intervention starts, immediately after the 8-week intervention is finished, and 4-month after the intervention is finished.
|
|
Change from Baseline rate of Resilience at post-intervention and 4-month follow-up.
大体时间：It is measured three weeks before the intervention starts, immediately after the 8-week intervention is finished, and 4-month after the intervention is finished.
|
Resilience scale (Wagnild & Young, 1993; Losoi et al 2013 modified)
|
It is measured three weeks before the intervention starts, immediately after the 8-week intervention is finished, and 4-month after the intervention is finished.
|
|
Change from Baseline rate of experiences of own health at post-intervention and 4-month follow-up.
大体时间：It is measured three weeks before the intervention starts, immediately after the 8-week intervention is finished, and 4-month after the intervention is finished.
|
Questionnaire Kunttu et al. 2017
|
It is measured three weeks before the intervention starts, immediately after the 8-week intervention is finished, and 4-month after the intervention is finished.
|
|
Change from Baseline rate of quality and length of sleep at post-intervention and 4-month follow-up.
大体时间：It is measured three weeks before the intervention starts, immediately after the 8-week intervention is finished, and 4-month after the intervention is finished.
|
Basic Nordic Sleep Questionnaire shortened (Partinen & Gislason 1995)
|
It is measured three weeks before the intervention starts, immediately after the 8-week intervention is finished, and 4-month after the intervention is finished.
|
|
Change from Baseline rate of fatigue in day-time at post-intervention and 4-month follow-up.
大体时间：It is measured three weeks before the intervention starts, immediately after the 8-week intervention is finished, and 4-month after the intervention is finished.
|
Questionnaire from Health 2000/2001 Research in Finland
|
It is measured three weeks before the intervention starts, immediately after the 8-week intervention is finished, and 4-month after the intervention is finished.
|
|
Change from Baseline amount of nightmares during previous month at post-intervention and 4-month follow-up.
大体时间：IIt is measured three weeks before the intervention starts, immediately after the 8-week intervention is finished, and 4-month after the intervention is finished.
|
Application of questionnaire Sandman et al 2015.
|
IIt is measured three weeks before the intervention starts, immediately after the 8-week intervention is finished, and 4-month after the intervention is finished.
|
|
Participant's own evaluation of his/her mental health
大体时间：Three weeks before the intervention starts
|
Participant's own evaluation of the symptoms of mental health during previous month.
|
Three weeks before the intervention starts
|
|
Change from Baseline approximate amount of exercise at post-intervention and 4-month follow-up.
大体时间：It is measured three weeks before the intervention starts, immediately after the 8-week intervention is finished, and 4-month after the intervention is finished.
|
Questionnaire from Health 2000/2001 Research in Finland
|
It is measured three weeks before the intervention starts, immediately after the 8-week intervention is finished, and 4-month after the intervention is finished.
|
|
Change from Baseline regularity of eating habits at post-intervention and 4-month follow-up.
大体时间：It is measured before intervention, post-intervention and 4-month follow-up.
|
Participant's own evaluation of the regularity of eating habits.
|
It is measured before intervention, post-intervention and 4-month follow-up.
|
|
Change from Baseline approximate amount of caffeine used daily. at post-intervention and 4-month follow-up.
大体时间：IIt is measured three weeks before the intervention starts, immediately after the 8-week intervention is finished, and 4-month after the intervention is finished.
|
Participant's own evaluation of the amount of daily caffeine use.
|
IIt is measured three weeks before the intervention starts, immediately after the 8-week intervention is finished, and 4-month after the intervention is finished.
|
|
Change from Baseline approximate amount use of alcohol and cigarettes daily.
大体时间：It is measured three weeks before the intervention starts, immediately after the 8-week intervention is finished, and 4-month after the intervention is finished.
|
Participant's own evaluation of approximate amount use of alcohol and cigarettes daily.
|
It is measured three weeks before the intervention starts, immediately after the 8-week intervention is finished, and 4-month after the intervention is finished.
|
|
Change from Baseline rate of Mindfulness skills at post-intervention and 4-month follow-up.
大体时间：It is measured three weeks before the intervention starts, immediately after the 8-week intervention is finished, and 4-month after the intervention is finished.
|
Freiburg Mindfulness Index (FMI) Walach, H., Buchheld, N., Buttenmüller, V., Kleinknecht, N., & Schmidt, S. 2006; Lehto, Uusitalo-Malmivaara & Repo 2015.
|
It is measured three weeks before the intervention starts, immediately after the 8-week intervention is finished, and 4-month after the intervention is finished.
|
|
Change from Baseline rate of stress and recovery of it at post-intervention and 4-month follow-up.
大体时间：IIt is measured three weeks before the intervention starts, immediately after the 8-week intervention is finished, and 4-month after the intervention is finished.
|
Application of measures of healthy work measure of Lundqvist & Mäkiopas 2016 and Elo et al. 1992.
|
IIt is measured three weeks before the intervention starts, immediately after the 8-week intervention is finished, and 4-month after the intervention is finished.
|
|
Previous experience in practicing of mindfulness and/or meditation
大体时间：It is measured three weeks before the intervention starts.
|
Participant's own evaluation of the amount of previous experience in practicing mindfulness and/or meditation
|
It is measured three weeks before the intervention starts.
|
|
Amount and quality of independent mindfulness practice
大体时间：Immediately after the 8-week intervention is finished.
|
Participant's self-evaluation of amount and quality of independent mindfulness practice
|
Immediately after the 8-week intervention is finished.
|
|
Change from post-intervention amount and quality of independent mindfulness practice at 4-month follow-up.
大体时间：Immediately after the 8-week intervention is finished, and 4-month after the intervention is finished.
|
Participant's self-evaluation of amount and quality of independent mindfulness practice.
|
Immediately after the 8-week intervention is finished, and 4-month after the intervention is finished.
|
合作者和调查者
在这里您可以找到参与这项研究的人员和组织。
调查人员
- 首席研究员：Saara Repo, PhD、University of Helsinki
出版物和有用的链接
负责输入研究信息的人员自愿提供这些出版物。这些可能与研究有关。
一般刊物
- Kunzler AM, Helmreich I, Konig J, Chmitorz A, Wessa M, Binder H, Lieb K. Psychological interventions to foster resilience in healthcare students. Cochrane Database Syst Rev. 2020 Jul 20;7(7):CD013684. doi: 10.1002/14651858.CD013684.
- Daya Z, Hearn JH. Mindfulness interventions in medical education: A systematic review of their impact on medical student stress, depression, fatigue and burnout. Med Teach. 2018 Feb;40(2):146-153. doi: 10.1080/0142159X.2017.1394999. Epub 2017 Nov 7.
- Miller R, Wankerl M, Stalder T, Kirschbaum C, Alexander N. The serotonin transporter gene-linked polymorphic region (5-HTTLPR) and cortisol stress reactivity: a meta-analysis. Mol Psychiatry. 2013 Sep;18(9):1018-24. doi: 10.1038/mp.2012.124. Epub 2012 Sep 4.
- Galante J, Dufour G, Vainre M, Wagner AP, Stochl J, Benton A, Lathia N, Howarth E, Jones PB. A mindfulness-based intervention to increase resilience to stress in university students (the Mindful Student Study): a pragmatic randomised controlled trial. Lancet Public Health. 2018 Feb;3(2):e72-e81. doi: 10.1016/S2468-2667(17)30231-1. Epub 2017 Dec 19.
研究记录日期
这些日期跟踪向 ClinicalTrials.gov 提交研究记录和摘要结果的进度。研究记录和报告的结果由国家医学图书馆 (NLM) 审查，以确保它们在发布到公共网站之前符合特定的质量控制标准。
研究主要日期
学习开始 (实际的)
2018年8月22日
初级完成 (预期的)
2019年4月15日
研究完成 (预期的)
2019年4月15日
研究注册日期
首次提交
2018年8月31日
首先提交符合 QC 标准的
2018年9月11日
首次发布 (实际的)
2018年9月13日
研究记录更新
最后更新发布 (实际的)
2018年9月13日
上次提交的符合 QC 标准的更新
2018年9月11日
最后验证
2018年9月1日
更多信息
与本研究相关的术语
关键字
其他研究编号
- MIndfulness for Students
计划个人参与者数据 (IPD)
计划共享个人参与者数据 (IPD)？
未定
药物和器械信息、研究文件
研究美国 FDA 监管的药品
不
研究美国 FDA 监管的设备产品
不
此信息直接从 clinicaltrials.gov 网站检索，没有任何更改。如果您有任何更改、删除或更新研究详细信息的请求，请联系 register@clinicaltrials.gov. clinicaltrials.gov 上实施更改，我们的网站上也会自动更新.