Clinical trial NCT03669016: MIndfulness for Students
Official title: Mindfulness for Students
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Well-being
Functional Ability
Stress
Mindfulness
Keywords: well-being
functional ability
stress
mindfulness
undergaduate students
Lead sponsor: University of Helsinki
Sponsor class: OTHER
Collaborators: name: University of Cambridge
name: University of Jyvaskyla
name: Technische Universität Dresden
First posted: 2018-09-13
Enrollment: 120
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: 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.

Detailed description: 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

1. Mindfulness for Students questionnaire data
2. Mindfulness for Students hair samples
3. Mindfulness for students -observation log
4. Mindfulness for students -interview data
5. Data collected in Student Compass -internet environment
6. 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.

Eligibility criteria: 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:

1. answers to the CORE-OM questionnaire and
2. answers to the questions where participants evaluate themselves their anxiety, depression, mental health.
3. If participant tell they have some other mental disorder, they are not accepted to the study.

Primary outcomes:
measure: Change from Baseline CORE-OM measure at post-intervention and 4-month follow-up.
timeFrame: 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.
Secondary outcomes:
measure: Change from Baseline rate of stress at post-intervention and 4-month follow-up.
timeFrame: 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.
measure: Change from Baseline rate of resilience in studies at post-intervention and 4-month follow-up.
timeFrame: 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.
measure: Change from Baseline rate of social support in studies at post-intervention and 4-month follow-up.
timeFrame: 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.
measure: Change from Baseline rate of study load in studies at post-intervention and 4-month follow-up.
timeFrame: 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.
measure: Students' possibilities to influence to their own studies
timeFrame: It is measured three weeks before the interventions start.
measure: Change from Baseline rate of functional ability in studies at post-intervention and 4-month follow-up.
timeFrame: 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.
measure: Change from Baseline rate of subjective experience of quality of life at post-intervention and 4-month follow-up.
timeFrame: 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.
measure: Change from Baseline rate of mental well-being Scale at post-intervention and 4-month follow-up.
timeFrame: 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.
measure: Change from Baseline rate of Personality at post-intervention and 4-month follow-up.
timeFrame: 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.
measure: Change from Baseline rate of sense of coherence at post-intervention and 4-month follow-up.
timeFrame: 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.
measure: Change from Baseline rate of Resilience at post-intervention and 4-month follow-up.
timeFrame: 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.
measure: Change from Baseline rate of experiences of own health at post-intervention and 4-month follow-up.
timeFrame: 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.
measure: Change from Baseline rate of quality and length of sleep at post-intervention and 4-month follow-up.
timeFrame: 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.
measure: Change from Baseline rate of fatigue in day-time at post-intervention and 4-month follow-up.
timeFrame: 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.
measure: Change from Baseline amount of nightmares during previous month at post-intervention and 4-month follow-up.
timeFrame: 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.
measure: Participant's own evaluation of his/her mental health
timeFrame: Three weeks before the intervention starts
measure: Change from Baseline approximate amount of exercise at post-intervention and 4-month follow-up.
timeFrame: 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.
measure: Change from Baseline regularity of eating habits at post-intervention and 4-month follow-up.
timeFrame: It is measured before intervention, post-intervention and 4-month follow-up.
measure: Change from Baseline approximate amount of caffeine used daily. at post-intervention and 4-month follow-up.
timeFrame: 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.
measure: Change from Baseline approximate amount use of alcohol and cigarettes daily.
timeFrame: 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.
measure: Change from Baseline rate of Mindfulness skills at post-intervention and 4-month follow-up.
timeFrame: 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.
measure: Change from Baseline rate of stress and recovery of it at post-intervention and 4-month follow-up.
timeFrame: 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.
measure: Previous experience in practicing of mindfulness and/or meditation
timeFrame: It is measured three weeks before the intervention starts.
measure: Amount and quality of independent mindfulness practice
timeFrame: Immediately after the 8-week intervention is finished.
measure: Change from post-intervention amount and quality of independent mindfulness practice at 4-month follow-up.
timeFrame: Immediately after the 8-week intervention is finished, and 4-month after the intervention is finished.
Other outcomes:
Locations:
city: Helsinki
country: Finland
facility: University of Helsinki
state: University Of Helsinki
Study officials:
affiliation: University of Helsinki
name: Saara Repo, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
citation: 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.
citation: 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.
citation: 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.