Overview

This trial is active, not recruiting.

Condition psychological distress
Treatment mindfulness training
Sponsor Norwegian Knowledge Centre for the Health Services
Collaborator University of Oslo
Start date September 2009
End date November 2018
Trial size 290 participants
Trial identifier NCT00892138, 08/4352 Norw Medical Assoc

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.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Allocation randomized
Endpoint classification efficacy study
Intervention model parallel assignment
Masking single blind (outcomes assessor)
Primary purpose prevention
Arm
(Experimental)
Mindfulness training
mindfulness training Mindfulness-Based Stress Reduction
7 week course modeled on MBSR according to Kabat-Zinn
(No Intervention)
Study program as usual

Primary Outcomes

Measure
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)
time frame: 9 years

Eligibility Criteria

Male or female participants of any age.

Inclusion Criteria: - 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.

Additional Information

Official title Mindfulness Training for Stress Management: A Two-centre Randomised Controlled Study of Medical and Psychology Students With Long-term Follow up
Trial information was received from ClinicalTrials.gov and was last updated in September 2014.
Information provided to ClinicalTrials.gov by Norwegian Knowledge Centre for the Health Services.