MIndfulness for Students

NCT ID: NCT03669016

Last Updated: 2018-09-13

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

120 participants

Study Classification

INTERVENTIONAL

Study Start Date

2018-08-22

Study Completion Date

2019-04-15

Brief Summary

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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.

Detailed Description

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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.

Conditions

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Well-being Functional Ability Stress Mindfulness

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Investigators Outcome Assessors

Study Groups

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Face-to-face group-based mindfulness

8 weeks training.

Group Type EXPERIMENTAL

Face-to-face group-based mindfulness

Intervention Type BEHAVIORAL

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.

Internet-based mindfulness

8 weeks training.

Group Type EXPERIMENTAL

Internet-based mindfulness

Intervention Type BEHAVIORAL

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.

Waiting-list control group

No training during the study.

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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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.

Intervention Type BEHAVIORAL

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.

Intervention Type BEHAVIORAL

Eligibility Criteria

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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.
Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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University of Cambridge

OTHER

Sponsor Role collaborator

University of Jyvaskyla

OTHER

Sponsor Role collaborator

Technische Universität Dresden

OTHER

Sponsor Role collaborator

University of Helsinki

OTHER

Sponsor Role lead

Responsible Party

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Saara Repo

Principal Investigator, Senior lecturer in University Pedagogy

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Saara Repo, PhD

Role: PRINCIPAL_INVESTIGATOR

University of Helsinki

Locations

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University of Helsinki

Helsinki, University of Helsinki, Finland

Site Status RECRUITING

Countries

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Finland

Central Contacts

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Saara Repo, PhD

Role: CONTACT

+358405189456

Tiina Paunio, PhD

Role: CONTACT

+358947163734

Facility Contacts

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Saara Repo, PhD

Role: primary

+358405189456

Tiina Paunio, PhD

Role: backup

+358947163734

References

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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.

Reference Type BACKGROUND
PMID: 22945032 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 29113526 (View on PubMed)

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.

Reference Type RESULT
PMID: 29422189 (View on PubMed)

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.

Reference Type DERIVED
PMID: 32691879 (View on PubMed)

Other Identifiers

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MIndfulness for Students

Identifier Type: -

Identifier Source: org_study_id

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