Stress ReductionNCT04558099
Effectiveness of MBSR Among Student Teachers
A study testing MBSR in people with Stress Reduction and Mental Well-being, run by University of Aarhus at 1 site in Denmark.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 16 to 40 yearsHealthy volunteers can take part
- Conditions the study is for
- Stress Reduction, Mental Well-being
- What is being tested?
- MBSR
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 67 participants
- Where
- 1 siteDenmark
- Study dates
- 1 Sep 2019to 12 Jan 2021
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 16 to 40 years
- All sexes
- Healthy volunteers accepted
- Child, Adult
Who may be able to join
- Danish student teacher
Who cannot join
- acute treatment-demanding clinical depression or a diagnosis of psychosis or schizophrenia
- abuse of alcohol, drugs, medicine
Trial locations and contacts
1 site in 1 country.
Denmark1 site
Aarhus University, Department of Clinical Medicine, Danish Center for Mindfulness
Aarhus, 8220
About this study
Official title: 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.
- Conditions
- Stress Reduction, Mental Well-being
- Being tested
- MBSR
- Medical subject headings
- Psychological Well-Being
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MBSRBehavioural
Described previously
| Study group | Role | What they receive |
|---|---|---|
| MBSR | Experimental | 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. Receives: Behavioral: MBSR |
| Wait-list control | No intervention | Usual practice |
What is being measured
The primary outcome is the main question the study is designed to answer.
Perceived Stress Scale
Change in perceived stress among the student teachers
Measured: 2 months from baseline
Secondary outcomes (5)
Brief Resilience Scale Brief Resilience Scale Brief Resilience Scale Brief Resilience Scale
Change in resilience among the student teachers
Measured: post MBSR (8 weeks from baseline)
Symptom Check List - 5
Change in symptoms of anxiety and depression among the student teachers
Measured: post MBSR (8 weeks from baseline)
WHO-5
Change in well-being among the student teachers
Measured: post MBSR (8 weeks from baseline)
Five Facet Mindfulness Questionnaire-15
Change in mindfulness among the student teachers
Measured: post MBSR (8 weeks from baseline)
Amsterdam Resting State Questionnaire
Change in resting state among the student teachers
Measured: post MBSR (8 weeks from baseline), 6 and 12 months from baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Sep 2020
- Study start1 Sep 2019
- Primary completion12 Jan 2021
- Study completion12 Jan 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Stress ReductionStudies of the same condition, open and under way.
- More trials run by University of AarhusThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Investigator
- Enrolment
- 67 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Aarhus
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Lone Fjorback, PhD, MD, Study director, Aarhus University, Danish Center for Mindfulness
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04558099
- Sponsor's protocol ID
- 08072020
- Status last verified
- Jul 2020
- First submitted
- 16 Sep 2020
- Last updated
- 22 Mar 2024
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Individual deidentified participant data will be shared by reasonable request, following publication of planned papers.
Publications
Juul L, Brorsen E, Gotzsche K, Nielsen BL, Fjorback LO. The Effects of a Mindfulness Program on Mental Health in Students at an Undergraduate Program for Teacher Education: A Randomized Controlled Trial in Real-Life. Front Psychol. 2021 Dec 6;12:722771. doi: 10.3389/fpsyg.2021.722771. eCollection 2021.
PubMed 34938226
Study at a glance
From the registry record, last updated by the sponsor on 22 Mar 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effectiveness of Mindfulness-based Stress Reduction Among Student Teachers
- ClinicalTrials.gov ID
- NCT04558099
- Acronym / sponsor ID
- 08072020
- Conditions
- Stress Reduction, Mental Well-being
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 67 participants (actual)
- Lead sponsor
- University of AarhusUniversity, hospital or other
- Study start
- 1 Sep 2019 (actual)
- Primary completion
- 12 Jan 2021 (actual)
- Study completion
- 12 Jan 2021 (actual)
- First posted
- 22 Sep 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| MBSR | Experimental | Behavioral: MBSRMBSR 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. |
| Wait-list control | No intervention | –Usual practice |
Who may qualify
- Ages
- 16 to 40 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult
Key inclusion criteria (1 listed)
- Danish student teacher
Key exclusion criteria (2 listed)
- acute treatment-demanding clinical depression or a diagnosis of psychosis or schizophrenia
- abuse of alcohol, drugs, medicine
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| MBSRDescribed previously | Behavioural | MBSR |
Primary outcome
Perceived Stress Scale
Time frame: 2 months from baseline
Change in perceived stress among the student teachers
5 secondary outcomes
Brief Resilience Scale Brief Resilience Scale Brief Resilience Scale Brief Resilience Scale
Time frame: post MBSR (8 weeks from baseline)
Symptom Check List - 5
Time frame: post MBSR (8 weeks from baseline)
WHO-5
Time frame: post MBSR (8 weeks from baseline)
Five Facet Mindfulness Questionnaire-15
Time frame: post MBSR (8 weeks from baseline)
Amsterdam Resting State Questionnaire
Time frame: post MBSR (8 weeks from baseline), 6 and 12 months from baseline
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Mar 2024.
- Derived from this study: PubMed 34938226Juul L, Brorsen E, Gotzsche K, Nielsen BL, Fjorback LO. The Effects of a Mindfulness Program on Mental Health in Students at an Undergraduate Program for Teacher Education: A Randomized Controlled Trial in Real-Life. Front Psychol. 2021 Dec 6;12:722771. doi: 10.3389/fpsyg.2021.722771. eCollection 2021.
- Individual participant dataSharing planned: Yes. Individual deidentified participant data will be shared by reasonable request, following publication of planned papers.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Lone Fjorback, PhD, MD study director
Aarhus University, Danish Center for Mindfulness
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing MBSR in people with Stress Reduction and Mental Well-being, run by University of Aarhus at 1 site in Denmark.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 22 Mar 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Denmark. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Perceived Stress Scale (time frame: 2 months from baseline). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04558099, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Mar 2024.