- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03886363
Effectiveness of MBSR Among School Teachers
March 21, 2019 updated by: University of Aarhus
Effectiveness of Mindfulness-Based Stress Reduction Among Danish School Teachers
The aim is to evaluate the effectiveness of Mindfulness-Based Stress Reduction among school teachers in Danish schools on mental weii-being in the teachers and their pupils.
The study is a cluster-randomised trial including 150 schools; 200 teachers; 4000 pupils from the five geographical regions in Denmark.
Study Overview
Status
Unknown
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Anticipated)
200
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
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-
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Aarhus, Denmark, 8220
- Recruiting
- Danish Center for Mindfulness
-
Contact:
- Lise Juul, PhD
- Phone Number: +4524619664
- Email: lise.juul@clin.au.dk
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-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
- Child
- Adult
- Older Adult
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
Inclusion Criteria:
- School teacher at a Danish school that commit to participate in a trial aiming to implement and evaluate the effectiveness of ".b" (a school-based mindfulness programme)
Exclusion Criteria:
- acute treatment-demanding clinical depression or a diagnosis of psychosis or schizophrenia
- abuse of alcohol, drugs, medicine
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Prevention
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
No Intervention: Wait-list control
Usual practice
|
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Experimental: MBSR
MBSR according to international standards (2.5 hours group session once a week in 8 weeks; a silence retreat day; and 45-60 minutes homework six days a week).
Content in accordance with MBSR curriculum.
|
Described previously
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Change in perceived stress among the school teachers
Time Frame: post MBSR (8 weeks from baseline), 6 and 12 months from baseline
|
Perceived Stress Scale
|
post MBSR (8 weeks from baseline), 6 and 12 months from baseline
|
|
Change in resilience among the school teachers
Time Frame: post MBSR (8 weeks from baseline), 6 and 12 months from baseline
|
Brief Resilience Scale
|
post MBSR (8 weeks from baseline), 6 and 12 months from baseline
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Change in symptoms of anxiety and depression among the school teachers
Time Frame: post MBSR (8 weeks from baseline), 6 and 12 months from baseline
|
Symptom Check List - 5
|
post MBSR (8 weeks from baseline), 6 and 12 months from baseline
|
|
Change in well-being among the school teachers
Time Frame: post MBSR (8 weeks from baseline), 6 and 12 months from baseline
|
WHO-5
|
post MBSR (8 weeks from baseline), 6 and 12 months from baseline
|
|
Change in mindfulness among the school teachers
Time Frame: post MBSR (8 weeks from baseline), 6 and 12 months from baseline
|
Five Facet Mindfulness Questionnaire-15
|
post MBSR (8 weeks from baseline), 6 and 12 months from baseline
|
|
Change in resting state among the school teachers
Time Frame: post MBSR (8 weeks from baseline), 6 and 12 months from baseline
|
Amsterdam Resting State Questionnaire
|
post MBSR (8 weeks from baseline), 6 and 12 months from baseline
|
|
Change in social capital among the pupils spending >5 hours with the teachers
Time Frame: post MBSR (8 weeks from baseline)
|
Questions about social capital
|
post MBSR (8 weeks from baseline)
|
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Change in strengths and difficulties among the pupils spending >5 hours with the teachers
Time Frame: post MBSR (8 weeks from baseline)
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Strengths and difficulties questionnaire (SDQ)
|
post MBSR (8 weeks from baseline)
|
|
Change in well-being among the pupils spending >5 hours with the teachers
Time Frame: post MBSR (8 weeks from baseline)
|
WHO-5
|
post MBSR (8 weeks from baseline)
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Study Director: Lone Fjorback, PhD, Aarhus University, Danish Center for Mindfulness
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
December 18, 2018
Primary Completion (Anticipated)
December 18, 2020
Study Completion (Anticipated)
December 18, 2020
Study Registration Dates
First Submitted
March 21, 2019
First Submitted That Met QC Criteria
March 21, 2019
First Posted (Actual)
March 22, 2019
Study Record Updates
Last Update Posted (Actual)
March 22, 2019
Last Update Submitted That Met QC Criteria
March 21, 2019
Last Verified
March 1, 2019
More Information
Terms related to this study
Other Study ID Numbers
- 05032019
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.