MIndfulness for Students (Mindfulstud)
11 de septiembre de 2018 actualizado por: 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.
Descripción general del estudio
Estado
Desconocido
Condiciones
Intervención / Tratamiento
Descripción detallada
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.
Tipo de estudio
Intervencionista
Inscripción (Anticipado)
120
Fase
- No aplica
Contactos y Ubicaciones
Esta sección proporciona los datos de contacto de quienes realizan el estudio e información sobre dónde se lleva a cabo este estudio.
Estudio Contacto
- Nombre: Saara Repo, PhD
- Número de teléfono: +358405189456
- Correo electrónico: saara.repo@helsinki.fi
Copia de seguridad de contactos de estudio
- Nombre: Tiina Paunio, PhD
- Número de teléfono: +358947163734
- Correo electrónico: tiina.paunio@helsinki.fi
Ubicaciones de estudio
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University Of Helsinki
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Helsinki, University Of Helsinki, Finlandia, 00014
- Reclutamiento
- University of Helsinki
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Contacto:
- Saara Repo, PhD
- Número de teléfono: +358405189456
- Correo electrónico: saara.repo@helsinki.fi
-
Contacto:
- Tiina Paunio, PhD
- Número de teléfono: +358947163734
- Correo electrónico: tiina.paunio@helsinki.fi
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Investigador principal:
- Saara Repo, PhD
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Criterios de participación
Los investigadores buscan personas que se ajusten a una determinada descripción, denominada criterio de elegibilidad. Algunos ejemplos de estos criterios son el estado de salud general de una persona o tratamientos previos.
Criterio de elegibilidad
Edades elegibles para estudiar
- Niño
- Adulto
- Adulto Mayor
Acepta Voluntarios Saludables
Sí
Géneros elegibles para el estudio
Todos
Descripción
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.
Plan de estudios
Esta sección proporciona detalles del plan de estudio, incluido cómo está diseñado el estudio y qué mide el estudio.
¿Cómo está diseñado el estudio?
Detalles de diseño
- Propósito principal: Tratamiento
- Asignación: Aleatorizado
- Modelo Intervencionista: Asignación paralela
- Enmascaramiento: Doble
Armas e Intervenciones
Grupo de participantes/brazo |
Intervención / Tratamiento |
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Experimental: Face-to-face group-based mindfulness
8 weeks training.
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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.
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Experimental: Internet-based mindfulness
8 weeks training.
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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.
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Sin intervención: Waiting-list control group
No training during the study.
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¿Qué mide el estudio?
Medidas de resultado primarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
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Change from Baseline CORE-OM measure at post-intervention and 4-month follow-up.
Periodo de tiempo: 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.
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CORE-OM, Clinical Outcomes in Routine Evaluation Outcome Measure.
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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.
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Medidas de resultado secundarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
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Change from Baseline rate of stress at post-intervention and 4-month follow-up.
Periodo de tiempo: 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.
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Cortisol as an indicator of stress which is measured from hair samples.
Stadler & Kirschbaum 2012.
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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.
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Change from Baseline rate of resilience in studies at post-intervention and 4-month follow-up.
Periodo de tiempo: 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.
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Workplace Acceptance and Action Questionnaire (WAAQ) applied for students.
Bond, Joda, and Guenole 2013; Asikainen, Hailikari, Mattson 2017.
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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.
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Change from Baseline rate of social support in studies at post-intervention and 4-month follow-up.
Periodo de tiempo: 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.
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Application of questionnaires of social support from Sarason et al. 1987 and Pyörälä et al. 2015.
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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.
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Change from Baseline rate of study load in studies at post-intervention and 4-month follow-up.
Periodo de tiempo: 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.
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Application of questionnaire of healthy work measure of Karasek & Theorell 1990.
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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.
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Students' possibilities to influence to their own studies
Periodo de tiempo: It is measured three weeks before the interventions start.
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Application of measures of healthy work measure.
Karasek & Theorell 1990.
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It is measured three weeks before the interventions start.
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Change from Baseline rate of functional ability in studies at post-intervention and 4-month follow-up.
Periodo de tiempo: 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.
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Application of functional ability at work.
Tuomi et al. 1998.
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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.
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Change from Baseline rate of subjective experience of quality of life at post-intervention and 4-month follow-up.
Periodo de tiempo: 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.
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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)
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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.
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Change from Baseline rate of mental well-being Scale at post-intervention and 4-month follow-up.
Periodo de tiempo: 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.
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The Warwick-Edinburgh Mental Well-being Scale
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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.
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Change from Baseline rate of Personality at post-intervention and 4-month follow-up.
Periodo de tiempo: 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.
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Parts of Big Five (Lang et al. 2011)
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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.
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Change from Baseline rate of sense of coherence at post-intervention and 4-month follow-up.
Periodo de tiempo: 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.
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Sence of coherence - SOC 3 (Antonovsky 1987; Schumann et al. 2003)
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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.
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Change from Baseline rate of Resilience at post-intervention and 4-month follow-up.
Periodo de tiempo: 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.
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Resilience scale (Wagnild & Young, 1993; Losoi et al 2013 modified)
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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.
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Change from Baseline rate of experiences of own health at post-intervention and 4-month follow-up.
Periodo de tiempo: 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.
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Questionnaire Kunttu et al. 2017
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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.
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Change from Baseline rate of quality and length of sleep at post-intervention and 4-month follow-up.
Periodo de tiempo: 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.
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Basic Nordic Sleep Questionnaire shortened (Partinen & Gislason 1995)
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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.
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Change from Baseline rate of fatigue in day-time at post-intervention and 4-month follow-up.
Periodo de tiempo: 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.
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Questionnaire from Health 2000/2001 Research in Finland
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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.
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Change from Baseline amount of nightmares during previous month at post-intervention and 4-month follow-up.
Periodo de tiempo: 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.
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Application of questionnaire Sandman et al 2015.
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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.
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Participant's own evaluation of his/her mental health
Periodo de tiempo: Three weeks before the intervention starts
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Participant's own evaluation of the symptoms of mental health during previous month.
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Three weeks before the intervention starts
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Change from Baseline approximate amount of exercise at post-intervention and 4-month follow-up.
Periodo de tiempo: 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.
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Questionnaire from Health 2000/2001 Research in Finland
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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.
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Change from Baseline regularity of eating habits at post-intervention and 4-month follow-up.
Periodo de tiempo: It is measured before intervention, post-intervention and 4-month follow-up.
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Participant's own evaluation of the regularity of eating habits.
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It is measured before intervention, post-intervention and 4-month follow-up.
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Change from Baseline approximate amount of caffeine used daily. at post-intervention and 4-month follow-up.
Periodo de tiempo: 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.
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Participant's own evaluation of the amount of daily caffeine use.
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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.
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Change from Baseline approximate amount use of alcohol and cigarettes daily.
Periodo de tiempo: 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.
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Participant's own evaluation of approximate amount use of alcohol and cigarettes daily.
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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.
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Change from Baseline rate of Mindfulness skills at post-intervention and 4-month follow-up.
Periodo de tiempo: 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.
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Freiburg Mindfulness Index (FMI) Walach, H., Buchheld, N., Buttenmüller, V., Kleinknecht, N., & Schmidt, S. 2006; Lehto, Uusitalo-Malmivaara & Repo 2015.
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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.
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Change from Baseline rate of stress and recovery of it at post-intervention and 4-month follow-up.
Periodo de tiempo: 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.
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Application of measures of healthy work measure of Lundqvist & Mäkiopas 2016 and Elo et al. 1992.
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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.
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Previous experience in practicing of mindfulness and/or meditation
Periodo de tiempo: It is measured three weeks before the intervention starts.
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Participant's own evaluation of the amount of previous experience in practicing mindfulness and/or meditation
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It is measured three weeks before the intervention starts.
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Amount and quality of independent mindfulness practice
Periodo de tiempo: Immediately after the 8-week intervention is finished.
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Participant's self-evaluation of amount and quality of independent mindfulness practice
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Immediately after the 8-week intervention is finished.
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Change from post-intervention amount and quality of independent mindfulness practice at 4-month follow-up.
Periodo de tiempo: Immediately after the 8-week intervention is finished, and 4-month after the intervention is finished.
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Participant's self-evaluation of amount and quality of independent mindfulness practice.
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Immediately after the 8-week intervention is finished, and 4-month after the intervention is finished.
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Colaboradores e Investigadores
Aquí es donde encontrará personas y organizaciones involucradas en este estudio.
Patrocinador
Investigadores
- Investigador principal: Saara Repo, PhD, University of Helsinki
Publicaciones y enlaces útiles
La persona responsable de ingresar información sobre el estudio proporciona voluntariamente estas publicaciones. Estos pueden ser sobre cualquier cosa relacionada con el estudio.
Publicaciones Generales
- 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.
- 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.
- 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.
- 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.
Fechas de registro del estudio
Estas fechas rastrean el progreso del registro del estudio y los envíos de resultados resumidos a ClinicalTrials.gov. Los registros del estudio y los resultados informados son revisados por la Biblioteca Nacional de Medicina (NLM) para asegurarse de que cumplan con los estándares de control de calidad específicos antes de publicarlos en el sitio web público.
Fechas importantes del estudio
Inicio del estudio (Actual)
22 de agosto de 2018
Finalización primaria (Anticipado)
15 de abril de 2019
Finalización del estudio (Anticipado)
15 de abril de 2019
Fechas de registro del estudio
Enviado por primera vez
31 de agosto de 2018
Primero enviado que cumplió con los criterios de control de calidad
11 de septiembre de 2018
Publicado por primera vez (Actual)
13 de septiembre de 2018
Actualizaciones de registros de estudio
Última actualización publicada (Actual)
13 de septiembre de 2018
Última actualización enviada que cumplió con los criterios de control de calidad
11 de septiembre de 2018
Última verificación
1 de septiembre de 2018
Más información
Términos relacionados con este estudio
Palabras clave
Otros números de identificación del estudio
- MIndfulness for Students
Plan de datos de participantes individuales (IPD)
¿Planea compartir datos de participantes individuales (IPD)?
INDECISO
Información sobre medicamentos y dispositivos, documentos del estudio
Estudia un producto farmacéutico regulado por la FDA de EE. UU.
No
Estudia un producto de dispositivo regulado por la FDA de EE. UU.
No
Esta información se obtuvo directamente del sitio web clinicaltrials.gov sin cambios. Si tiene alguna solicitud para cambiar, eliminar o actualizar los detalles de su estudio, comuníquese con register@clinicaltrials.gov. Tan pronto como se implemente un cambio en clinicaltrials.gov, también se actualizará automáticamente en nuestro sitio web. .
Ensayos clínicos sobre Face-to-face group-based mindfulness
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