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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT03886363
Other study ID # 05032019
Secondary ID
Status Recruiting
Phase N/A
First received
Last updated
Start date December 18, 2018
Est. completion date December 18, 2020

Study information

Verified date March 2019
Source University of Aarhus
Contact Lise Juul, PhD, associate professor
Phone +4524619664
Email lise.juul@clin.au.dk
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

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.


Recruitment information / eligibility

Status Recruiting
Enrollment 200
Est. completion date December 18, 2020
Est. primary completion date December 18, 2020
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group N/A and older
Eligibility 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 Design


Related Conditions & MeSH terms


Intervention

Behavioral:
MBSR
Described previously

Locations

Country Name City State
Denmark Danish Center for Mindfulness Aarhus

Sponsors (1)

Lead Sponsor Collaborator
University of Aarhus

Country where clinical trial is conducted

Denmark, 

Outcome

Type Measure Description Time frame Safety issue
Primary Change in perceived stress among the school teachers Perceived Stress Scale post MBSR (8 weeks from baseline), 6 and 12 months from baseline
Primary Change in resilience among the school teachers Brief Resilience Scale post MBSR (8 weeks from baseline), 6 and 12 months from baseline
Secondary Change in symptoms of anxiety and depression among the school teachers Symptom Check List - 5 post MBSR (8 weeks from baseline), 6 and 12 months from baseline
Secondary Change in well-being among the school teachers WHO-5 post MBSR (8 weeks from baseline), 6 and 12 months from baseline
Secondary Change in mindfulness among the school teachers Five Facet Mindfulness Questionnaire-15 post MBSR (8 weeks from baseline), 6 and 12 months from baseline
Secondary Change in resting state among the school teachers Amsterdam Resting State Questionnaire post MBSR (8 weeks from baseline), 6 and 12 months from baseline
Secondary Change in social capital among the pupils spending >5 hours with the teachers Questions about social capital post MBSR (8 weeks from baseline)
Secondary Change in strengths and difficulties among the pupils spending >5 hours with the teachers Strengths and difficulties questionnaire (SDQ) post MBSR (8 weeks from baseline)
Secondary Change in well-being among the pupils spending >5 hours with the teachers WHO-5 post MBSR (8 weeks from baseline)
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