- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04558008
Effectiveness of MBSR Among Teachers at Upper Secondary Schools and Schools of Health and Social Care
September 16, 2020 updated by: University of Aarhus
Effectiveness of Online Mindfulness-based Stress Reduction Among Teachers at Upper Secondary Schools and Schools of Health and Social Care
The aim is to evaluate the effectiveness of online Mindfulness-based Stress Reduction among school teachers in Danish upper secondary schools and schools of health and social care on mental well-being in the teachers and their students.
The study is a cluster-randomised trial including 43 schools; 76 teachers; 1.000 students.
Study Overview
Status
Unknown
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Actual)
76
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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Aarhus, Denmark, 8220
- Danish Center for Mindfulness
-
-
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 upper secondary school or school of health and social care that commit to participate in a trial aiming to implement and evaluate the effectiveness of 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 |
---|---|
Experimental: Online 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
|
No Intervention: Wait-list control
Usual practice
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Perceived Stress Scale
Time Frame: 6 months from baseline
|
Change in perceived stress among the school teachers
|
6 months from baseline
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Perceived Stress Scale
Time Frame: post MBSR (8 weeks from baseline) and 12 months from baseline
|
Change in perceived stress among the school teachers
|
post MBSR (8 weeks from baseline) and 12 months from baseline
|
Brief Resilience Scale
Time Frame: post MBSR (8 weeks from baseline), 6 and 12 months from baseline
|
Change in resilience among the school teachers
|
post MBSR (8 weeks from baseline), 6 and 12 months from baseline
|
Symptom Check List - 5
Time Frame: post MBSR (8 weeks from baseline), 6 and 12 months from baseline
|
Change in symptoms of anxiety and depression among the school teachers
|
post MBSR (8 weeks from baseline), 6 and 12 months from baseline
|
WHO-5
Time Frame: post MBSR (8 weeks from baseline), 6 and 12 months from baseline
|
Change in well-being among the school teachers
|
post MBSR (8 weeks from baseline), 6 and 12 months from baseline
|
Five Facet Mindfulness Questionnaire-15
Time Frame: post MBSR (8 weeks from baseline), 6 and 12 months from baseline
|
Change in mindfulness among the school teachers
|
post MBSR (8 weeks from baseline), 6 and 12 months from baseline
|
Amsterdam Resting State Questionnaire
Time Frame: post MBSR (8 weeks from baseline), 6 and 12 months from baseline
|
Change in resting state among the school teachers
|
post MBSR (8 weeks from baseline), 6 and 12 months 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, MD, 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)
October 28, 2019
Primary Completion (Anticipated)
October 28, 2021
Study Completion (Anticipated)
October 28, 2021
Study Registration Dates
First Submitted
September 16, 2020
First Submitted That Met QC Criteria
September 16, 2020
First Posted (Actual)
September 22, 2020
Study Record Updates
Last Update Posted (Actual)
September 22, 2020
Last Update Submitted That Met QC Criteria
September 16, 2020
Last Verified
July 1, 2020
More Information
Terms related to this study
Other Study ID Numbers
- 07072020
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Yes
IPD Plan Description
Individual deidentified participant data will be shared by reasonable request, following publication of planned papers.
IPD Sharing Supporting Information Type
- Study Protocol
- Statistical Analysis Plan (SAP)
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.
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