Mindfulness Training for Stress Management

Psychological Distress Clinical Trial

Official title:

Mindfulness Training for Stress Management: A Two-centre Randomised Controlled Study of Medical and Psychology Students With Long-term Follow up

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT00892138
• Other study ID #: 08/4352 Norw Medical Assoc
• Status: Active, not recruiting
• Phase: N/A
• First received: May 1, 2009
• Last updated: September 23, 2014
• Start date: September 2009
• Est. completion date: November 2018

Study information

• Verified date: September 2014
• Source: Norwegian Knowledge Centre for the Health Services
• Contact: n/a
• Is FDA regulated: No
• Health authority: Norway:National Committee for Medical and Health Research Ethics
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 290
• Est. completion date: November 2018
• Est. primary completion date: November 2018
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: N/A and older

Eligibility

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.

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Outcomes Assessor), Primary Purpose: Prevention

Related Conditions & MeSH terms

• Psychological Distress

Intervention

Behavioral:
• Mindfulness training
7 week course modeled on MBSR according to Kabat-Zinn

Locations

Country	Name	City	State
Norway	University of Oslo	Oslo
Norway	University of Tromso	Tromso

Sponsors (4)

Lead Sponsor	Collaborator
Norwegian Knowledge Centre for the Health Services	Norwegian Medical Association, University of Oslo, University of Tromso

Country where clinical trial is conducted

Norway, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No