Mindfulness Training for Stress Management
1 other identifier
interventional
290
1 country
2
Brief Summary
This study will assess the short and long term effects of a group-based mindfulness programme (Mindfulness-Based Stress Reduction, MBSR) on first year medical and psychology students at the Universities of Oslo and Tromso. The primary outcome variables are mental distress, student stress and subsequent work stress, subjective wellbeing, empathy, mindfulness and spirituality. The investigators will also study explanatory moderator and mediator variables. The study will be a two-centre randomized controlled study involving 288 medical and psychology students from the University of Oslo and from the University of Tromso. The sample size calculation is based on a reduction in mental distress and perceived medical/psychology school stress of 20% in the intervention group. The control group will not receive an intervention. After the initial seven week course (taking place in 2009 and 2010) the intervention group will receive a follow-up session of 1.5 hours twice a year throughout their study course of 5-6 years. The follow-up period will last until 1 year after graduation in the Oslo cohort and until 3 years after graduation in the Tromso cohort.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable
Started Sep 2009
Longer than P75 for not_applicable
2 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
May 1, 2009
CompletedFirst Posted
Study publicly available on registry
May 4, 2009
CompletedStudy Start
First participant enrolled
September 1, 2009
CompletedPrimary Completion
Last participant's last visit for primary outcome
November 1, 2018
CompletedStudy Completion
Last participant's last visit for all outcomes
November 1, 2018
CompletedSeptember 25, 2014
September 1, 2014
9.2 years
May 1, 2009
September 23, 2014
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
The primary outcome variables are mental distress (GHQ12, SCL5 and MBI), student stress (PMSS) and subsequent work stress, subjective wellbeing (SWB), empathy (JPSE), mindfulness (FFMS)
The following predictor variables will be measured: Coping (WCCL), Regulatory focus, Personality (BCI), Perceived social support, Life events
9 years
Study Arms (2)
Mindfulness training
EXPERIMENTALMindfulness training
Control
NO INTERVENTIONStudy program as usual
Interventions
7 week course modeled on MBSR according to Kabat-Zinn
Eligibility Criteria
You may qualify if:
- All students in term 3 of their medical and psychology study at the University of Oslo in the autumn of 2009, and spring of 2010.
- All students in term 3 of their medical and psychology study at the University of Tromso in the autumn of 2010, and autumn of 2011.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Norwegian Knowledge Centre for the Health Serviceslead
- University of Oslocollaborator
- University of Tromsocollaborator
- Norwegian Medical Associationcollaborator
Study Sites (2)
University of Oslo
Oslo, Norway
University of Tromso
Tromsø, Norway
Related Publications (3)
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.
PMID: 32691879DERIVEDde Vibe M, Solhaug I, Rosenvinge JH, Tyssen R, Hanley A, Garland E. Six-year positive effects of a mindfulness-based intervention on mindfulness, coping and well-being in medical and psychology students; Results from a randomized controlled trial. PLoS One. 2018 Apr 24;13(4):e0196053. doi: 10.1371/journal.pone.0196053. eCollection 2018.
PMID: 29689081DERIVEDde Vibe M, Solhaug I, Tyssen R, Friborg O, Rosenvinge JH, Sorlie T, Bjorndal A. Mindfulness training for stress management: a randomised controlled study of medical and psychology students. BMC Med Educ. 2013 Aug 13;13:107. doi: 10.1186/1472-6920-13-107.
PMID: 23941053DERIVED
MeSH Terms
Interventions
Intervention Hierarchy (Ancestors)
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Who Masked
- OUTCOMES ASSESSOR
- Purpose
- PREVENTION
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER GOV
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Senior Advisor
Study Record Dates
First Submitted
May 1, 2009
First Posted
May 4, 2009
Study Start
September 1, 2009
Primary Completion
November 1, 2018
Study Completion
November 1, 2018
Last Updated
September 25, 2014
Record last verified: 2014-09