Stress ReductionNCT04558008
Effectiveness of MBSR Among Teachers at Upper Secondary Schools and Schools of Health and Social Care
A study testing Online 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 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. Read more about this study
- Who is it for?
- Any ageHealthy volunteers can take part
- Conditions the study is for
- Stress Reduction, Mental Well-being
- What is being tested?
- Online MBSR
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 76 participants
- Where
- 1 siteDenmark
- Study dates
- 28 Oct 2019to 28 Oct 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 Any age
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Who may be able to join
- 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.
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.
About this study
Official title: 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.
- Conditions
- Stress Reduction, Mental Well-being
- Being tested
- Online 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.
Online MBSRBehavioural
Described previously
| Study group | Role | What they receive |
|---|---|---|
| Online 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: Online 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 school teachers
Measured: 6 months from baseline
Secondary outcomes (6)
Perceived Stress Scale
Change in perceived stress among the school teachers
Measured: post MBSR (8 weeks from baseline) and 12 months from baseline
Brief Resilience Scale
Change in resilience among the school teachers
Measured: post MBSR (8 weeks from baseline), 6 and 12 months from baseline
Symptom Check List - 5
Change in symptoms of anxiety and depression among the school teachers
Measured: post MBSR (8 weeks from baseline), 6 and 12 months from baseline
WHO-5
Change in well-being among the school teachers
Measured: post MBSR (8 weeks from baseline), 6 and 12 months from baseline
Five Facet Mindfulness Questionnaire-15
Change in mindfulness among the school teachers
Measured: post MBSR (8 weeks from baseline), 6 and 12 months from baseline
Amsterdam Resting State Questionnaire
Change in resting state among the school 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 start28 Oct 2019
- Primary completion28 Oct 2021 (estimated)
- Study completion28 Oct 2021 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- 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
- 76 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
- NCT04558008
- Sponsor's protocol ID
- 07072020
- Status last verified
- Jul 2020
- First submitted
- 16 Sep 2020
- Last updated
- 22 Sep 2020
- 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.
Study at a glance
From the registry record, last updated by the sponsor on 22 Sep 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effectiveness of Online Mindfulness-based Stress Reduction Among Teachers at Upper Secondary Schools and Schools of Health and Social Care
- ClinicalTrials.gov ID
- NCT04558008
- Acronym / sponsor ID
- 07072020
- Conditions
- Stress Reduction, Mental Well-being
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 76 participants (actual)
- Lead sponsor
- University of AarhusUniversity, hospital or other
- Study start
- 28 Oct 2019 (actual)
- Primary completion
- 28 Oct 2021 (estimated)
- Study completion
- 28 Oct 2021 (estimated)
- 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 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 design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Online MBSR | Experimental | Behavioral: Online 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
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (1 listed)
- 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.
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 |
|---|---|---|
| Online MBSRDescribed previously | Behavioural | Online MBSR |
Primary outcome
Perceived Stress Scale
Time frame: 6 months from baseline
Change in perceived stress among the school teachers
6 secondary outcomes
Perceived Stress Scale
Time frame: 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
Symptom Check List - 5
Time frame: 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
Five Facet Mindfulness Questionnaire-15
Time frame: 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
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Sep 2020.
- 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 Online 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: status not confirmed, as of the sponsor's last update on 22 Sep 2020. 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?
Results are not available in the source record.
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: 6 months from baseline). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 Sep 2020.