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MIndfulness for Students (Mindfulstud)

11 сентября 2018 г. обновлено: 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.

Обзор исследования

Статус

Неизвестный

Условия

Вмешательство/лечение

Подробное описание

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.

Тип исследования

Интервенционный

Регистрация (Ожидаемый)

120

Фаза

Непригодный

Контакты и местонахождение

В этом разделе приведены контактные данные лиц, проводящих исследование, и информация о том, где проводится это исследование.

Контакты исследования

Имя: Saara Repo, PhD
Номер телефона: +358405189456
Электронная почта: saara.repo@helsinki.fi

Учебное резервное копирование контактов

Имя: Tiina Paunio, PhD
Номер телефона: +358947163734
Электронная почта: tiina.paunio@helsinki.fi

Места учебы

Финляндия
- University Of Helsinki
  - Helsinki, University Of Helsinki, Финляндия, 00014
    - Рекрутинг
    - University of Helsinki
    - Контакт:
      
      Saara Repo, PhD
      
      Номер телефона: +358405189456
      
      Электронная почта: saara.repo@helsinki.fi
    - Контакт:
      
      Tiina Paunio, PhD
      
      Номер телефона: +358947163734
      
      Электронная почта: tiina.paunio@helsinki.fi
    - Главный следователь:
      
      Saara Repo, PhD

Критерии участия

Исследователи ищут людей, которые соответствуют определенному описанию, называемому критериям приемлемости. Некоторыми примерами этих критериев являются общее состояние здоровья человека или предшествующее лечение.

Критерии приемлемости

Возраст, подходящий для обучения

Ребенок
Взрослый
Пожилой взрослый

Принимает здоровых добровольцев

Да

Полы, имеющие право на обучение

Все

Описание

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.

Учебный план

В этом разделе представлена подробная информация о плане исследования, в том числе о том, как планируется исследование и что оно измеряет.

Как устроено исследование?

Детали дизайна

Основная цель: Уход
Распределение: Рандомизированный
Интервенционная модель: Параллельное назначение
Маскировка: Двойной

Количество рук

Оружие и интервенции

Группа участников / Армия	Вмешательство/лечение
Экспериментальный: Face-to-face group-based mindfulness 8 weeks training.	Поведенческий: 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.
Экспериментальный: Internet-based mindfulness 8 weeks training.	Поведенческий: 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.
Без вмешательства: Waiting-list control group No training during the study.

Что измеряет исследование?

Первичные показатели результатов

Мера результата	Мера Описание	Временное ограничение
Change from Baseline CORE-OM measure at post-intervention and 4-month follow-up. Временное ограничение: 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.

Вторичные показатели результатов

Соавторы и исследователи

Здесь вы найдете людей и организации, участвующие в этом исследовании.

Спонсор

University of Helsinki

Соавторы

Technische Universität Dresden

University of Cambridge

University of Jyvaskyla

Следователи

Главный следователь: Saara Repo, PhD, University of Helsinki

Публикации и полезные ссылки

Лицо, ответственное за внесение сведений об исследовании, добровольно предоставляет эти публикации. Это может быть что угодно, связанное с исследованием.

Общие публикации

Даты записи исследования

Эти даты отслеживают ход отправки отчетов об исследованиях и сводных результатов на сайт ClinicalTrials.gov. Записи исследований и сообщаемые результаты проверяются Национальной медицинской библиотекой (NLM), чтобы убедиться, что они соответствуют определенным стандартам контроля качества, прежде чем публиковать их на общедоступном веб-сайте.

Изучение основных дат

Начало исследования (Действительный)

22 августа 2018 г.

Первичное завершение (Ожидаемый)

15 апреля 2019 г.

Завершение исследования (Ожидаемый)

15 апреля 2019 г.

Даты регистрации исследования

Первый отправленный

31 августа 2018 г.

Впервые представлено, что соответствует критериям контроля качества

11 сентября 2018 г.

Первый опубликованный (Действительный)

13 сентября 2018 г.

Обновления учебных записей

Последнее опубликованное обновление (Действительный)

13 сентября 2018 г.

Последнее отправленное обновление, отвечающее критериям контроля качества

11 сентября 2018 г.

Последняя проверка

1 сентября 2018 г.

Дополнительная информация

Термины, связанные с этим исследованием

Ключевые слова

Другие идентификационные номера исследования

MIndfulness for Students

Планирование данных отдельных участников (IPD)

Планируете делиться данными об отдельных участниках (IPD)?

НЕ РЕШЕНО

Информация о лекарствах и устройствах, исследовательские документы

Изучает лекарственный продукт, регулируемый FDA США.

Нет

Изучает продукт устройства, регулируемый Управлением по санитарному надзору за качеством пищевых продуктов и медикаментов США.

Нет

Эта информация была получена непосредственно с веб-сайта clinicaltrials.gov без каких-либо изменений. Если у вас есть запросы на изменение, удаление или обновление сведений об исследовании, обращайтесь по адресу register@clinicaltrials.gov. Как только изменение будет реализовано на clinicaltrials.gov, оно будет автоматически обновлено и на нашем веб-сайте. .

Клинические исследования Стресс

VA Office of Research and Development
VA St. Louis Health Care System

Прекращено

Упражнения для рук в сравнении с фармакологическими стресс-тестами для клинического результата (ArmCrank)

Ветераны, направленные в St. Louis VAMC Stress Tes

Соединенные Штаты

Клинические исследования Face-to-face group-based mindfulness

IRCCS Centro San Giovanni di Dio Fatebenefratelli
IRCCS San Raffaele; Fondazione Don Carlo Gnocchi Onlus; IRCCS Centro Neurolesi Bonino-Pulejo...

Активный, не рекрутирующий

Телереабилитация при легких когнитивных нарушениях

Легкое когнитивное нарушение

Италия

Мера результата	Мера Описание	Временное ограничение
Change from Baseline rate of stress at post-intervention and 4-month follow-up. Временное ограничение: 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. Временное ограничение: 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. Временное ограничение: 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. Временное ограничение: 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 Временное ограничение: 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. Временное ограничение: 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. Временное ограничение: 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. Временное ограничение: 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. Временное ограничение: 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. Временное ограничение: 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. Временное ограничение: 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. Временное ограничение: 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. Временное ограничение: 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. Временное ограничение: 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. Временное ограничение: 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 Временное ограничение: 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. Временное ограничение: 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. Временное ограничение: 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. Временное ограничение: 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. Временное ограничение: 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. Временное ограничение: 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. Временное ограничение: 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 Временное ограничение: 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 Временное ограничение: 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. Временное ограничение: 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)