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Mindfulness Training for Stress Management

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT00892138
Recruitment Status : Unknown
Verified September 2014 by Michael de Vibe, Norwegian Knowledge Centre for the Health Services.
Recruitment status was:  Active, not recruiting
First Posted : May 4, 2009
Last Update Posted : September 25, 2014
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

Tracking Information
First Submitted Date  ICMJE May 1, 2009
First Posted Date  ICMJE May 4, 2009
Last Update Posted Date September 25, 2014
Study Start Date  ICMJE September 2009
Estimated Primary Completion Date November 2018   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: April 25, 2012)
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 ]
The following predictor variables will be measured: Coping (WCCL), Regulatory focus, Personality (BCI), Perceived social support, Life events
Original Primary Outcome Measures  ICMJE
 (submitted: May 1, 2009)
The primary outcome variables are mental distress, student stress and subsequent work stress, subjective wellbeing, empathy, mindfulness and spirituality [ Time Frame: 9 years ]
Change History
Current Secondary Outcome Measures  ICMJE Not Provided
Original Secondary Outcome Measures  ICMJE Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Mindfulness Training for Stress Management
Official Title  ICMJE Mindfulness Training for Stress Management: A Two-centre Randomised Controlled Study of Medical and Psychology Students With Long-term Follow up
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.

Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Prevention
Condition  ICMJE Psychological Distress
Intervention  ICMJE Behavioral: Mindfulness training
7 week course modeled on MBSR according to Kabat-Zinn
Other Name: Mindfulness-Based Stress Reduction
Study Arms  ICMJE
  • Experimental: Mindfulness training
    Mindfulness training
    Intervention: Behavioral: Mindfulness training
  • No Intervention: Control
    Study program as usual
Publications *

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Unknown status
Actual Enrollment  ICMJE
 (submitted: April 25, 2012)
290
Original Estimated Enrollment  ICMJE
 (submitted: May 1, 2009)
325
Estimated Study Completion Date  ICMJE November 2018
Estimated Primary Completion Date November 2018   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE Child, Adult, Older Adult
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Norway
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT00892138
Other Study ID Numbers  ICMJE 08/4352 Norw Medical Assoc
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Michael de Vibe, Norwegian Knowledge Centre for the Health Services
Study Sponsor  ICMJE Norwegian Knowledge Centre for the Health Services
Collaborators  ICMJE
  • University of Oslo
  • University of Tromso
  • Norwegian Medical Association
Investigators  ICMJE Not Provided
PRS Account Norwegian Knowledge Centre for the Health Services
Verification Date September 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP