Mindfulness for Students
试验速览
- 阶段
- 不适用
- 入组人数
- 120
- 试验地点
- 1
- 主要终点
- Change from Baseline CORE-OM measure at post-intervention and 4-month follow-up.
研究概览
简要总结
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.
详细描述
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.
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
- Double (Investigator, Outcomes Assessor)
入排标准
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •All undergraduate students of Faculty of Medicine, University of Helsinki who have started their studies in year 2009 or after that.
排除标准
- •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.
研究组 & 干预措施
Face-to-face group-based mindfulness
8 weeks training.
干预措施: Face-to-face group-based mindfulness (Behavioral)
Internet-based mindfulness
8 weeks training.
干预措施: Internet-based mindfulness (Behavioral)
Waiting-list control group
No training during the study.
结局指标
主要结局
Change from Baseline CORE-OM measure at post-intervention and 4-month follow-up.
时间窗: 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.
次要结局
- Change from Baseline approximate amount of exercise at post-intervention and 4-month follow-up.(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.(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.(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.(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.(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.)
- Previous experience in practicing of mindfulness and/or meditation(It is measured three weeks before the intervention starts.)
- 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.(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.(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.(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.(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.(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.(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.(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.(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 rate of stress at post-intervention and 4-month follow-up.(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.(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.(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.(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(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.(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.(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.(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 his/her mental health(Three weeks before the intervention starts)
- Change from Baseline rate of stress and recovery of it at post-intervention and 4-month follow-up.(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.)
研究者
Saara Repo
Principal Investigator, Senior lecturer in University Pedagogy
University of Helsinki