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MIndfulness for Students (Mindfulstud)

11 września 2018 zaktualizowane przez: 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.

Przegląd badań

Status

Nieznany

Warunki

Interwencja / Leczenie

Szczegółowy opis

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.

Typ studiów

Interwencyjne

Zapisy (Oczekiwany)

120

Faza

  • Nie dotyczy

Kontakty i lokalizacje

Ta sekcja zawiera dane kontaktowe osób prowadzących badanie oraz informacje o tym, gdzie badanie jest przeprowadzane.

Kontakt w sprawie studiów

Kopia zapasowa kontaktu do badania

Lokalizacje studiów

  • Finlandia
    • University Of Helsinki
      • Helsinki, University Of Helsinki, Finlandia, 00014
        • Rekrutacyjny
        • University of Helsinki
        • Kontakt:
        • Kontakt:
        • Główny śledczy:
          • Saara Repo, PhD

Kryteria uczestnictwa

Badacze szukają osób, które pasują do określonego opisu, zwanego kryteriami kwalifikacyjnymi. Niektóre przykłady tych kryteriów to ogólny stan zdrowia danej osoby lub wcześniejsze leczenie.

Kryteria kwalifikacji

Wiek uprawniający do nauki

  • Dziecko
  • Dorosły
  • Starszy dorosły

Akceptuje zdrowych ochotników

Tak

Płeć kwalifikująca się do nauki

Wszystko

Opis

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.

Plan studiów

Ta sekcja zawiera szczegółowe informacje na temat planu badania, w tym sposób zaprojektowania badania i jego pomiary.

Jak projektuje się badanie?

Szczegóły projektu

  • Główny cel: Leczenie
  • Przydział: Randomizowane
  • Model interwencyjny: Przydział równoległy
  • Maskowanie: Podwójnie

Broń i interwencje

Grupa uczestników / Arm
Interwencja / Leczenie
Eksperymentalny: Face-to-face group-based mindfulness
8 weeks training.
Behawioralne: 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.
Eksperymentalny: Internet-based mindfulness
8 weeks training.
Behawioralne: 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.
Brak interwencji: Waiting-list control group
No training during the study.

Co mierzy badanie?

Podstawowe miary wyniku

Miara wyniku
Opis środka
Ramy czasowe
Change from Baseline CORE-OM measure at post-intervention and 4-month follow-up.
Ramy czasowe: 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.

Miary wyników drugorzędnych

Miara wyniku
Opis środka
Ramy czasowe
Change from Baseline rate of stress at post-intervention and 4-month follow-up.
Ramy czasowe: 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.
Ramy czasowe: 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.
Ramy czasowe: 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.
Ramy czasowe: 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
Ramy czasowe: 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.
Ramy czasowe: 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.
Ramy czasowe: 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.
Ramy czasowe: 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.
Ramy czasowe: 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.
Ramy czasowe: 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.
Ramy czasowe: 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.
Ramy czasowe: 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.
Ramy czasowe: 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.
Ramy czasowe: 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.
Ramy czasowe: 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
Ramy czasowe: 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.
Ramy czasowe: 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.
Ramy czasowe: 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.
Ramy czasowe: 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.
Ramy czasowe: 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.
Ramy czasowe: 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.
Ramy czasowe: 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
Ramy czasowe: 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
Ramy czasowe: 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.
Ramy czasowe: 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.

Współpracownicy i badacze

Tutaj znajdziesz osoby i organizacje zaangażowane w to badanie.

Sponsor

University of Helsinki

Współpracownicy

Technische Universität Dresden
University of Cambridge
University of Jyvaskyla

Śledczy

  • Główny śledczy: Saara Repo, PhD, University of Helsinki

Publikacje i pomocne linki

Osoba odpowiedzialna za wprowadzenie informacji o badaniu dobrowolnie udostępnia te publikacje. Mogą one dotyczyć wszystkiego, co jest związane z badaniem.

Publikacje ogólne

Daty zapisu na studia

Daty te śledzą postęp w przesyłaniu rekordów badań i podsumowań wyników do ClinicalTrials.gov. Zapisy badań i zgłoszone wyniki są przeglądane przez National Library of Medicine (NLM), aby upewnić się, że spełniają określone standardy kontroli jakości, zanim zostaną opublikowane na publicznej stronie internetowej.

Główne daty studiów

Rozpoczęcie studiów (Rzeczywisty)

22 sierpnia 2018

Zakończenie podstawowe (Oczekiwany)

15 kwietnia 2019

Ukończenie studiów (Oczekiwany)

15 kwietnia 2019

Daty rejestracji na studia

Pierwszy przesłany

31 sierpnia 2018

Pierwszy przesłany, który spełnia kryteria kontroli jakości

11 września 2018

Pierwszy wysłany (Rzeczywisty)

13 września 2018

Aktualizacje rekordów badań

Ostatnia wysłana aktualizacja (Rzeczywisty)

13 września 2018

Ostatnia przesłana aktualizacja, która spełniała kryteria kontroli jakości

11 września 2018

Ostatnia weryfikacja

1 września 2018

Więcej informacji

Terminy związane z tym badaniem

Słowa kluczowe

Inne numery identyfikacyjne badania

  • MIndfulness for Students

Plan dla danych uczestnika indywidualnego (IPD)

Planujesz udostępniać dane poszczególnych uczestników (IPD)?

NIEZDECYDOWANY

Informacje o lekach i urządzeniach, dokumenty badawcze

Bada produkt leczniczy regulowany przez amerykańską FDA

Nie

Bada produkt urządzenia regulowany przez amerykańską FDA

Nie

Te informacje zostały pobrane bezpośrednio ze strony internetowej clinicaltrials.gov bez żadnych zmian. Jeśli chcesz zmienić, usunąć lub zaktualizować dane swojego badania, skontaktuj się z register@clinicaltrials.gov. Gdy tylko zmiana zostanie wprowadzona na stronie clinicaltrials.gov, zostanie ona automatycznie zaktualizowana również na naszej stronie internetowej .

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