Stress ReductionNCT03886363
Effectiveness of MBSR Among School 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 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. 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?
- MBSR
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 200 participants
- Where
- 1 siteDenmark
- Study dates
- 18 Dec 2018to 18 Dec 2020
- 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 school that commit to participate in a trial aiming to implement and evaluate the effectiveness of ".b" (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.
Denmark1 site, 1 recruiting
- Recruiting
Danish Center for Mindfulness
Aarhus, 8220
Lise Juul, PhD, +4524619664, lise.juul@clin.au.dk
About this study
Official title: Effectiveness of Mindfulness-Based Stress Reduction Among Danish School Teachers
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.
- 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.
Change in perceived stress among the school teachers
Perceived Stress Scale
Measured: post MBSR (8 weeks from baseline), 6 and 12 months from baseline
Change in resilience among the school teachers
Brief Resilience Scale
Measured: post MBSR (8 weeks from baseline), 6 and 12 months from baseline
Secondary outcomes (7)
Change in symptoms of anxiety and depression among the school teachers
Symptom Check List - 5
Measured: post MBSR (8 weeks from baseline), 6 and 12 months from baseline
Change in well-being among the school teachers
WHO-5
Measured: post MBSR (8 weeks from baseline), 6 and 12 months from baseline
Change in mindfulness among the school teachers
Five Facet Mindfulness Questionnaire-15
Measured: post MBSR (8 weeks from baseline), 6 and 12 months from baseline
Change in resting state among the school teachers
Amsterdam Resting State Questionnaire
Measured: post MBSR (8 weeks from baseline), 6 and 12 months from baseline
Change in social capital among the pupils spending >5 hours with the teachers
Questions about social capital
Measured: post MBSR (8 weeks from baseline)
Change in strengths and difficulties among the pupils spending >5 hours with the teachers
Strengths and difficulties questionnaire (SDQ)
Measured: post MBSR (8 weeks from baseline)
Change in well-being among the pupils spending >5 hours with the teachers
WHO-5
Measured: post MBSR (8 weeks 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 Mar 2019
- Study start18 Dec 2018
- Primary completion18 Dec 2020 (estimated)
- Study completion18 Dec 2020 (estimated)
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
- 200 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Aarhus
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Lone Fjorback, PhD, Study director, Aarhus University, Danish Center for Mindfulness
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03886363
- Sponsor's protocol ID
- 05032019
- Status last verified
- Mar 2019
- First submitted
- 21 Mar 2019
- Last updated
- 22 Mar 2019
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Juul L, Bonde EH, Fjorback LO. Altered self-reported resting state mediates the effects of Mindfulness-Based Stress Reduction on mental health: a longitudinal path model analysis within a community-based randomized trial with 6-months follow-up. Front Psychol. 2023 Jun 20;14:1154277. doi: 10.3389/fpsyg.2023.1154277. eCollection 2023.
PubMed 37408978
Study at a glance
From the registry record, last updated by the sponsor on 22 Mar 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effectiveness of Mindfulness-Based Stress Reduction Among Danish School Teachers
- ClinicalTrials.gov ID
- NCT03886363
- Acronym / sponsor ID
- 05032019
- Conditions
- Stress Reduction, Mental Well-being
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 200 participants (estimated)
- Lead sponsor
- University of AarhusUniversity, hospital or other
- Study start
- 18 Dec 2018 (actual)
- Primary completion
- 18 Dec 2020 (estimated)
- Study completion
- 18 Dec 2020 (estimated)
- First posted
- 22 Mar 2019 (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 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.
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
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (1 listed)
- 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)
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
Change in perceived stress among the school teachers
Time frame: post MBSR (8 weeks from baseline), 6 and 12 months from baseline
Perceived Stress Scale
Change in resilience among the school teachers
Time frame: post MBSR (8 weeks from baseline), 6 and 12 months from baseline
Brief Resilience Scale
7 secondary outcomes
Change in symptoms of anxiety and depression among the school teachers
Time frame: post MBSR (8 weeks from baseline), 6 and 12 months from baseline
Change in well-being among the school teachers
Time frame: post MBSR (8 weeks from baseline), 6 and 12 months from baseline
Change in mindfulness among the school teachers
Time frame: post MBSR (8 weeks from baseline), 6 and 12 months from baseline
Change in resting state among the school teachers
Time frame: post MBSR (8 weeks from baseline), 6 and 12 months from baseline
Change in social capital among the pupils spending >5 hours with the teachers
Time frame: post MBSR (8 weeks from baseline)
Change in strengths and difficulties among the pupils spending >5 hours with the teachers
Time frame: post MBSR (8 weeks from baseline)
Change in well-being among the pupils spending >5 hours with the teachers
Time frame: post MBSR (8 weeks 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 Mar 2019.
- Derived from this study: PubMed 37408978Juul L, Bonde EH, Fjorback LO. Altered self-reported resting state mediates the effects of Mindfulness-Based Stress Reduction on mental health: a longitudinal path model analysis within a community-based randomized trial with 6-months follow-up. Front Psychol. 2023 Jun 20;14:1154277. doi: 10.3389/fpsyg.2023.1154277. eCollection 2023.
Related trials for Stress Reduction
Recruiting
Effect of a Brief Daily Digital Meditation on Well-Being in US Young Adults (BEGIN II)
Mental Health and General Well-being
Recruiting
Stress Reduction and Lifestyle Modification in Irritable Bowel Syndrome Patients
Irritable Bowel Syndrome
Not yet recruiting
Meditation Apps for Stress Management in Black Women
Psychological Stress
Active, not recruiting
Online Mindfulness-Based Stress Reduction for the Mental Health of Healthcare Professionals
Occupational Stress or Workplace Stress, Burnout, Professionals
Recruiting
VOCALE LBD: Online Peer Support for Caregivers of People With Lewy Body Dementia
Lewy Bodies Disease, Depression Disorder
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 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: status not confirmed, as of the sponsor's last update on 22 Mar 2019. 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?
Contact Lise Juul, PhD, associate professor (+4524619664, lise.juul@clin.au.dk), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in perceived stress among the school teachers (time frame: post MBSR (8 weeks from baseline), 6 and 12 months from baseline). The study lists 2 primary outcomes in all. 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 NCT03886363, 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 2019.