Mindfulness Training for Stress Management

This study is ongoing, but not recruiting participants.
Sponsor:
Collaborators:
University of Oslo
University of Tromso
Norwegian Medical Association
Information provided by (Responsible Party):
Michael de Vibe, Norwegian Knowledge Centre for the Health Services
ClinicalTrials.gov Identifier:
NCT00892138
First received: May 1, 2009
Last updated: April 25, 2012
Last verified: April 2012
  Purpose

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 approximately 190 medical and psychology students from the University of Oslo and 135 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.


Condition Intervention
Psychological Distress
Behavioral: Mindfulness training

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Outcomes Assessor)
Primary Purpose: Prevention
Official Title: Mindfulness Training for Stress Management: A Two-centre Randomised Controlled Study of Medical and Psychology Students With Long-term Follow up

Further study details as provided by Norwegian Knowledge Centre for the Health Services:

Primary Outcome Measures:
  • 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 ] [ Designated as safety issue: No ]
    The following predictor variables will be measured: Coping (WCCL), Regulatory focus, Personality (BCI), Perceived social support, Life events


Enrollment: 290
Study Start Date: September 2009
Estimated Study Completion Date: November 2018
Estimated Primary Completion Date: November 2018 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Mindfulness training
Mindfulness training
Behavioral: Mindfulness training
7 week course modeled on MBSR according to Kabat-Zinn
Other Name: Mindfulness-Based Stress Reduction
No Intervention: Control
Study program as usual

  Eligibility

Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00892138

Locations
Norway
University of Oslo
Oslo, Norway
University of Tromso
Tromso, Norway
Sponsors and Collaborators
Norwegian Knowledge Centre for the Health Services
University of Oslo
University of Tromso
Norwegian Medical Association
  More Information

No publications provided by Norwegian Knowledge Centre for the Health Services

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Michael de Vibe, Senior Advisor, Norwegian Knowledge Centre for the Health Services
ClinicalTrials.gov Identifier: NCT00892138     History of Changes
Other Study ID Numbers: 08/4352 Norw Medical Assoc
Study First Received: May 1, 2009
Last Updated: April 25, 2012
Health Authority: Norway:National Committee for Medical and Health Research Ethics

Keywords provided by Norwegian Knowledge Centre for the Health Services:
mindfulness training
medical students
psychology students
stress management
personal development
stress

ClinicalTrials.gov processed this record on September 18, 2014