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MIndfulness for Students (Mindfulstud)

11. September 2018 aktualisiert von: 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.

Studienübersicht

Status

Unbekannt

Bedingungen

Intervention / Behandlung

Detaillierte Beschreibung

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.

Studientyp

Interventionell

Einschreibung (Voraussichtlich)

120

Phase

Unzutreffend

Kontakte und Standorte

Dieser Abschnitt enthält die Kontaktdaten derjenigen, die die Studie durchführen, und Informationen darüber, wo diese Studie durchgeführt wird.

Studienkontakt

Name: Saara Repo, PhD
Telefonnummer: +358405189456
E-Mail: saara.repo@helsinki.fi

Studieren Sie die Kontaktsicherung

Name: Tiina Paunio, PhD
Telefonnummer: +358947163734
E-Mail: tiina.paunio@helsinki.fi

Studienorte

Finnland
- University Of Helsinki
  - Helsinki, University Of Helsinki, Finnland, 00014
    - Rekrutierung
    - University of Helsinki
    - Kontakt:
      
      Saara Repo, PhD
      
      Telefonnummer: +358405189456
      
      E-Mail: saara.repo@helsinki.fi
    - Kontakt:
      
      Tiina Paunio, PhD
      
      Telefonnummer: +358947163734
      
      E-Mail: tiina.paunio@helsinki.fi
    - Hauptermittler:
      
      Saara Repo, PhD

Teilnahmekriterien

Forscher suchen nach Personen, die einer bestimmten Beschreibung entsprechen, die als Auswahlkriterien bezeichnet werden. Einige Beispiele für diese Kriterien sind der allgemeine Gesundheitszustand einer Person oder frühere Behandlungen.

Zulassungskriterien

Studienberechtigtes Alter

Kind
Erwachsene
Älterer Erwachsener

Akzeptiert gesunde Freiwillige

Studienberechtigte Geschlechter

Alle

Beschreibung

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.

Studienplan

Dieser Abschnitt enthält Einzelheiten zum Studienplan, einschließlich des Studiendesigns und der Messung der Studieninhalte.

Wie ist die Studie aufgebaut?

Designdetails

Hauptzweck: Behandlung
Zuteilung: Zufällig
Interventionsmodell: Parallele Zuordnung
Maskierung: Doppelt

Anzahl der Arme

Waffen und Interventionen

Teilnehmergruppe / Arm	Intervention / Behandlung
Experimental: Face-to-face group-based mindfulness 8 weeks training.	Verhalten: 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.
Experimental: Internet-based mindfulness 8 weeks training.	Verhalten: 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.
Kein Eingriff: Waiting-list control group No training during the study.

Was misst die Studie?

Primäre Ergebnismessungen

Ergebnis Maßnahme	Maßnahmenbeschreibung	Zeitfenster
Change from Baseline CORE-OM measure at post-intervention and 4-month follow-up. Zeitfenster: 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.

Sekundäre Ergebnismessungen

Mitarbeiter und Ermittler

Hier finden Sie Personen und Organisationen, die an dieser Studie beteiligt sind.

Sponsor

University of Helsinki

Mitarbeiter

Technische Universität Dresden

University of Cambridge

University of Jyvaskyla

Ermittler

Hauptermittler: Saara Repo, PhD, University of Helsinki

Publikationen und hilfreiche Links

Die Bereitstellung dieser Publikationen erfolgt freiwillig durch die für die Eingabe von Informationen über die Studie verantwortliche Person. Diese können sich auf alles beziehen, was mit dem Studium zu tun hat.

Allgemeine Veröffentlichungen

Studienaufzeichnungsdaten

Diese Daten verfolgen den Fortschritt der Übermittlung von Studienaufzeichnungen und zusammenfassenden Ergebnissen an ClinicalTrials.gov. Studienaufzeichnungen und gemeldete Ergebnisse werden von der National Library of Medicine (NLM) überprüft, um sicherzustellen, dass sie bestimmten Qualitätskontrollstandards entsprechen, bevor sie auf der öffentlichen Website veröffentlicht werden.

Haupttermine studieren

Studienbeginn (Tatsächlich)

22. August 2018

Primärer Abschluss (Voraussichtlich)

15. April 2019

Studienabschluss (Voraussichtlich)

15. April 2019

Studienanmeldedaten

Zuerst eingereicht

31. August 2018

Zuerst eingereicht, das die QC-Kriterien erfüllt hat

11. September 2018

Zuerst gepostet (Tatsächlich)

13. September 2018

Studienaufzeichnungsaktualisierungen

Letztes Update gepostet (Tatsächlich)

13. September 2018

Letztes eingereichtes Update, das die QC-Kriterien erfüllt

11. September 2018

Zuletzt verifiziert

1. September 2018

Mehr Informationen

Begriffe im Zusammenhang mit dieser Studie

Schlüsselwörter

Andere Studien-ID-Nummern

MIndfulness for Students

Plan für individuelle Teilnehmerdaten (IPD)

Planen Sie, individuelle Teilnehmerdaten (IPD) zu teilen?

UNENTSCHIEDEN

Arzneimittel- und Geräteinformationen, Studienunterlagen

Studiert ein von der US-amerikanischen FDA reguliertes Arzneimittelprodukt

Nein

Studiert ein von der US-amerikanischen FDA reguliertes Geräteprodukt

Nein

Diese Informationen wurden ohne Änderungen direkt von der Website clinicaltrials.gov abgerufen. Wenn Sie Ihre Studiendaten ändern, entfernen oder aktualisieren möchten, wenden Sie sich bitte an register@clinicaltrials.gov. Sobald eine Änderung auf clinicaltrials.gov implementiert wird, wird diese automatisch auch auf unserer Website aktualisiert .

Klinische Studien zur Betonen

Massachusetts General Hospital

Abgeschlossen

Neuronale Korrelate der Stressreduktion

Betonen | Emotionaler Stress | Psychologischer Stress | Sozialer Stress | Lebensstress

Vereinigte Staaten
Inspiration at Work
Northwestern University

Rekrutierung

Intervention zur Rückkehr zur Arbeit bei Depressionen (DRIVEN)

Stress, emotional | Job-Stress

Vereinigte Staaten
Maharishi International University
Center for Wellness and Achievement in Education

Abgeschlossen

Meditation und emotionale Intelligenz

Job-Stress | Wahrgenommener Stress
Holly Risdon
BPAi; American Institute of Stress

Noch keine Rekrutierung

Validierung einer Mitarbeiter-Stressmessung am Remote-Arbeitsplatz, eingebettet in eine neuartige Mitarbeiter-Wohlfühl-App

Arbeitsbedingter Stress
Mälardalen University

Abgeschlossen

Evaluation of a Web Application That Supports Behavior Change in Work Related Stress

Gesundheitsverhalten | Psychischer Stress | Occupation-Related Stress Disorder

Schweden
Oregon Health and Science University

Abgeschlossen

Stressabbau: Eine Pilotstudie mit Jugendlichen

Psychologischer Stress | Physiologischer Stress
Brock University
Mitacs

Abgeschlossen

HRV- und Coaching-Vorbereitungsphasen-Studie

Angst Depression | Gesundheitsverhalten | Arbeitsbedingter Stress | Job-Stress

Kanada
Northwestern University
Harvard University

Aktiv, nicht rekrutierend

Biologie, Identitäts- und Gelegenheitsstudie (BIO)

Stress, Psychisch | Stress, emotional | Stress, Physiologisch

Vereinigte Staaten
University of Southern Denmark
Headspace Health

Abgeschlossen

Die Wirkung von Achtsamkeit auf psychophysiologischen Stress in einer Population mit erhöhten Stresssymptomen

Psychologischer Stress | Physiologischer Stress

Dänemark
National Taiwan University Hospital
Taipei City Hospital

Unbekannt

Die Auswirkung der Arbeitsbelastung auf die Stressreaktion des Arztes

Psychologischer Stress | Physiologischer Stress

Taiwan

Klinische Studien zur Face-to-face group-based mindfulness

Stanford University

Beendet

Gehirnkonnektivitäts- und Achtsamkeitstraining bei Jugendlichen mit bipolarer Störung nicht anders angegeben (NOS)

Bipolare Störung, NOS

Vereinigte Staaten

Ergebnis Maßnahme	Maßnahmenbeschreibung	Zeitfenster
Change from Baseline rate of stress at post-intervention and 4-month follow-up. Zeitfenster: 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. Zeitfenster: 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. Zeitfenster: 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. Zeitfenster: 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 Zeitfenster: 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. Zeitfenster: 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. Zeitfenster: 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. Zeitfenster: 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. Zeitfenster: 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. Zeitfenster: 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. Zeitfenster: 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. Zeitfenster: 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. Zeitfenster: 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. Zeitfenster: 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. Zeitfenster: 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 Zeitfenster: 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. Zeitfenster: 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. Zeitfenster: 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. Zeitfenster: 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. Zeitfenster: 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. Zeitfenster: 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. Zeitfenster: 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 Zeitfenster: 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 Zeitfenster: 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. Zeitfenster: 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)