NCT03669016

Brief Summary

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
120

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Aug 2018

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

August 22, 2018

Completed
9 days until next milestone

First Submitted

Initial submission to the registry

August 31, 2018

Completed
13 days until next milestone

First Posted

Study publicly available on registry

September 13, 2018

Completed
7 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 15, 2019

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

April 15, 2019

Completed
Last Updated

September 13, 2018

Status Verified

September 1, 2018

Enrollment Period

8 months

First QC Date

August 31, 2018

Last Update Submit

September 11, 2018

Conditions

Keywords

well-beingfunctional abilitystressmindfulnessundergaduate students

Outcome Measures

Primary Outcomes (1)

  • Change from Baseline CORE-OM measure at post-intervention and 4-month follow-up.

    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.

Secondary Outcomes (25)

  • Change from Baseline rate of stress at post-intervention and 4-month follow-up.

    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.

    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.

    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.

    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

    It is measured three weeks before the interventions start.

  • +20 more secondary outcomes

Study Arms (3)

Face-to-face group-based mindfulness

EXPERIMENTAL

8 weeks training.

Behavioral: Face-to-face group-based mindfulness

Internet-based mindfulness

EXPERIMENTAL

8 weeks training.

Behavioral: Internet-based mindfulness

Waiting-list control group

NO INTERVENTION

No training during the study.

Interventions

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.

Face-to-face group-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.

Internet-based mindfulness

Eligibility Criteria

Sexall
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • \- All undergraduate students of Faculty of Medicine, University of Helsinki who have started their studies in year 2009 or after that.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Helsinki

Helsinki, University of Helsinki, 00014, Finland

RECRUITING

Related Publications (4)

  • 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.

    PMID: 22945032BACKGROUND
  • 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.

    PMID: 29113526BACKGROUND
  • 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.

  • 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.

Study Officials

  • Saara Repo, PhD

    University of Helsinki

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator, Senior lecturer in University Pedagogy

Study Record Dates

First Submitted

August 31, 2018

First Posted

September 13, 2018

Study Start

August 22, 2018

Primary Completion

April 15, 2019

Study Completion

April 15, 2019

Last Updated

September 13, 2018

Record last verified: 2018-09

Locations