- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04558099
Effectiveness of MBSR Among Student Teachers
March 21, 2024 updated by: University of Aarhus
Effectiveness of Mindfulness-based Stress Reduction Among Student Teachers
The aim is to evaluate the effectiveness of Mindfulness-based Stress Reduction among Danish student teachers on their mental well-being.
The study is a randomised, controlled trial including 100 teachers.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Actual)
67
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
- Aarhus University, Department of Clinical Medicine, 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
Accepts Healthy Volunteers
Yes
Description
Inclusion Criteria:
- Danish student teacher
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 |
|---|---|---|
|
Perceived Stress Scale
Time Frame: 2 months from baseline
|
Change in perceived stress among the student teachers
|
2 months from baseline
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Brief Resilience Scale Brief Resilience Scale Brief Resilience Scale Brief Resilience Scale
Time Frame: post MBSR (8 weeks from baseline)
|
Change in resilience among the student teachers
|
post MBSR (8 weeks from baseline)
|
|
Symptom Check List - 5
Time Frame: post MBSR (8 weeks from baseline)
|
Change in symptoms of anxiety and depression among the student teachers
|
post MBSR (8 weeks from baseline)
|
|
WHO-5
Time Frame: post MBSR (8 weeks from baseline)
|
Change in well-being among the student teachers
|
post MBSR (8 weeks from baseline)
|
|
Five Facet Mindfulness Questionnaire-15
Time Frame: post MBSR (8 weeks from baseline)
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Change in mindfulness among the student teachers
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post MBSR (8 weeks 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 student 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
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
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)
September 1, 2019
Primary Completion (Actual)
January 12, 2021
Study Completion (Actual)
January 12, 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)
March 22, 2024
Last Update Submitted That Met QC Criteria
March 21, 2024
Last Verified
July 1, 2020
More Information
Terms related to this study
Other Study ID Numbers
- 08072020
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.
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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