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MIndfulness for Students (Mindfulstud)

11. září 2018 aktualizováno: 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.

Přehled studie

Postavení

Neznámý

Podmínky

Intervence / Léčba

Detailní popis

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.

Typ studie

Intervenční

Zápis (Očekávaný)

120

Fáze

Nelze použít

Kontakty a umístění

Tato část poskytuje kontaktní údaje pro ty, kteří studii provádějí, a informace o tom, kde se tato studie provádí.

Studijní kontakt

Jméno: Saara Repo, PhD
Telefonní číslo: +358405189456
E-mail: saara.repo@helsinki.fi

Studijní záloha kontaktů

Jméno: Tiina Paunio, PhD
Telefonní číslo: +358947163734
E-mail: tiina.paunio@helsinki.fi

Studijní místa

Finsko
- University Of Helsinki
  - Helsinki, University Of Helsinki, Finsko, 00014
    - Nábor
    - University of Helsinki
    - Kontakt:
      
      Saara Repo, PhD
      
      Telefonní číslo: +358405189456
      
      E-mail: saara.repo@helsinki.fi
    - Kontakt:
      
      Tiina Paunio, PhD
      
      Telefonní číslo: +358947163734
      
      E-mail: tiina.paunio@helsinki.fi
    - Vrchní vyšetřovatel:
      
      Saara Repo, PhD

Kritéria účasti

Výzkumníci hledají lidi, kteří odpovídají určitému popisu, kterému se říká kritéria způsobilosti. Některé příklady těchto kritérií jsou celkový zdravotní stav osoby nebo předchozí léčba.

Kritéria způsobilosti

Věk způsobilý ke studiu

Dítě
Dospělý
Starší dospělý

Přijímá zdravé dobrovolníky

Ano

Pohlaví způsobilá ke studiu

Všechno

Popis

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.

Studijní plán

Tato část poskytuje podrobnosti o studijním plánu, včetně toho, jak je studie navržena a co studie měří.

Jak je studie koncipována?

Detaily designu

Primární účel: Léčba
Přidělení: Randomizované
Intervenční model: Paralelní přiřazení
Maskování: Dvojnásobek

Počet zbraní

Zbraně a zásahy

Skupina účastníků / Arm	Intervence / Léčba
Experimentální: Face-to-face group-based mindfulness 8 weeks training.	Behaviorální: Face-to-face group-based mindfulness 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.
Experimentální: Internet-based mindfulness 8 weeks training.	Behaviorální: Internet-based mindfulness 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.
Žádný zásah: Waiting-list control group No training during the study.

Co je měření studie?

Primární výstupní opatření

Měření výsledku	Popis opatření	Časové okno
Change from Baseline CORE-OM measure at post-intervention and 4-month follow-up. Časové okno: 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.

Sekundární výstupní opatření

Spolupracovníci a vyšetřovatelé

Zde najdete lidi a organizace zapojené do této studie.

Sponzor

University of Helsinki

Spolupracovníci

Technische Universität Dresden

University of Cambridge

University of Jyvaskyla

Vyšetřovatelé

Vrchní vyšetřovatel: Saara Repo, PhD, University of Helsinki

Publikace a užitečné odkazy

Osoba odpovědná za zadávání informací o studiu tyto publikace poskytuje dobrovolně. Mohou se týkat čehokoli, co souvisí se studiem.

Obecné publikace

Termíny studijních záznamů

Tato data sledují průběh záznamů studie a předkládání souhrnných výsledků na ClinicalTrials.gov. Záznamy ze studií a hlášené výsledky jsou před zveřejněním na veřejné webové stránce přezkoumány Národní lékařskou knihovnou (NLM), aby se ujistily, že splňují specifické standardy kontroly kvality.

Hlavní termíny studia

Začátek studia (Aktuální)

22. srpna 2018

Primární dokončení (Očekávaný)

15. dubna 2019

Dokončení studie (Očekávaný)

15. dubna 2019

Termíny zápisu do studia

První předloženo

31. srpna 2018

První předloženo, které splnilo kritéria kontroly kvality

11. září 2018

První zveřejněno (Aktuální)

13. září 2018

Aktualizace studijních záznamů

Poslední zveřejněná aktualizace (Aktuální)

13. září 2018

Odeslaná poslední aktualizace, která splnila kritéria kontroly kvality

11. září 2018

Naposledy ověřeno

1. září 2018

Více informací

Termíny související s touto studií

Klíčová slova

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MIndfulness for Students

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Tyto informace byly beze změn načteny přímo z webu clinicaltrials.gov. Máte-li jakékoli požadavky na změnu, odstranění nebo aktualizaci podrobností studie, kontaktujte prosím register@clinicaltrials.gov. Jakmile bude změna implementována na clinicaltrials.gov, bude automaticky aktualizována i na našem webu .

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Spojené státy

Měření výsledku	Popis opatření	Časové okno
Change from Baseline rate of stress at post-intervention and 4-month follow-up. Časové okno: 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. Časové okno: 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. Časové okno: 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. Časové okno: 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 Časové okno: 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. Časové okno: 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. Časové okno: 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. Časové okno: 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. Časové okno: 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. Časové okno: 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. Časové okno: 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. Časové okno: 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. Časové okno: 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. Časové okno: 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. Časové okno: 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 Časové okno: 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. Časové okno: 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. Časové okno: 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. Časové okno: 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. Časové okno: 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. Časové okno: 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. Časové okno: 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 Časové okno: 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 Časové okno: 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. Časové okno: 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.

MIndfulness for Students (Mindfulstud)