Mental HealthNCT04610333
On Top of Everything
A study testing Modified MBSR programme in people with Mental Health and Youth, run by University of Aarhus at 1 site in Denmark.
Trial summary
Our primary aim of this trial is to evaluate the effectiveness of a teacher training programme to teach mindfulness as part of regular classroom teaching in the total population of students in Danish upper secondary schools and schools of health and social care, respectively, on students' self-reported mental health… Read more about this study
- Who is it for?
- Ages 16 to 24 yearsHealthy volunteers can take part
- Conditions the study is for
- Mental Health, Youth, Mindfulness
- What is being tested?
- Modified MBSR programme
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 992 participants
- Where
- 1 siteDenmark
- Study dates
- 13 Jan 2021to 24 Nov 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 24 years
- All sexes
- Healthy volunteers accepted
- Child, Adult
Who may be able to join
- All students in the enrolled school classes
Who cannot join
- None
Trial locations and contacts
1 site in 1 country.
About this study
Official title: On Top of Everything. A Study Protocol for a Cluster-Randomised Controlled Trial Testing a Teacher Training Programme to Teach Mindfulness Among Students in Danish Upper Secondary Schools and Schools of Health and Social Care
Our primary aim of this trial is to evaluate the effectiveness of a teacher training programme to teach mindfulness as part of regular classroom teaching in the total population of students in Danish upper secondary schools and schools of health and social care, respectively, on students' self-reported mental health at six-month follow-up.
Our secondary aim is to evaluate the effectiveness of the teacher training programme to teach mindfulness in a vulnerable subgroup of students on their self-reported mental health at three and six months after baseline.
Read the detailed description
The study is designed as a pragmatic cluster randomised two-arm trial including 43 Danish schools (30 upper secondary schools and 13 schools of health and social care). The schools included a total of 76 school teachers for teacher training (44 teachers from upper secondary schools and 32 teachers from schools of health and social care). Each included teacher will be asked to recruit a class of students (15-30 students) to test the effectiveness of the modified MBSR programme (in total approx. 1.000 students).
- Conditions
- Mental Health, Youth, Mindfulness, Stress
- Being tested
- Modified MBSR programme
- Keywords
- School-based intervention, Population-based preventive strategy, Public health
- 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.
Modified MBSR programmeBehavioural
1 hour group session once a week in 10 weeks
| Study group | Role | What they receive |
|---|---|---|
| School teacher training | Experimental | Teacher training programme:
* 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.
* Four-day residental course
* 3 x 2 seminar days
Modified MBSR programme delivered to the students:
- 1hour group session once a week in 10 weeks taught by the educated teachers on class Receives: Behavioral: Modified MBSR programme |
| Usual practice | No intervention | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
Warwick-Edinburgh Mental Well-Being Scale (SWEMWBS) - The short version
Change in the score among the total study population
Measured: Six months after baseline
Secondary outcomes (17)
Warwick-Edinburgh Mental Well-Being Scale (SWEMWBS) - The short version
Change in the score among the total study population
Measured: Three months after baseline
Strengths and Difficulties Questionnaire (SDQ) - The youth self-report version
Change in the score among the total study population
Measured: Three months after baseline
Strengths and Difficulties Questionnaire (SDQ) - The youth self-report version
Change in the score among the total study population
Measured: Six months after baseline
Perseived Stress Scale
Change in the score among the total study population
Measured: Three months after baseline
Perseived Stress Scale
Change in the score among the total study population
Measured: Six months after baseline
Depression Anxiety Stress Scale (DASS) - The short form version
Change in the score among the total study population
Measured: Three months after baseline
Depression Anxiety Stress Scale (DASS) - The short form version
Change in the score among the total study population
Measured: Six months after baseline
Brief Resilience Scale (BRS)
Change in the score among the total study population
Measured: Three months after baseline
Brief Resilience Scale (BRS)
Change in the score among the total study population
Measured: Six months after baseline
Three-Item Loneliness Scale (T-ILS)
Change in the score among the total study population
Measured: Three months after baseline
Three-Item Loneliness Scale (T-ILS)
Change in the score among the total study population
Measured: Six months after baseline
Experiences Questionnaire (EQ) - Decentering subscale
Change in the score among the total study population
Measured: Three months after baseline
Experiences Questionnaire (EQ) - Decentering subscale
Change in the score among the total study population
Measured: Six months after baseline
EQ-5D
Change in the score among the total study population
Measured: Three months after baseline
EQ-5D
Change in the score among the total study population
Measured: Six months after baseline
Karolinska Sleep Questionnaire - Modified version
Change in the score among the total study population
Measured: Three months after baseline
Karolinska Sleep Questionnaire - Modified version
Change in the score among the total study population
Measured: Six months after baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Oct 2020
- Study start13 Jan 2021
- Primary completion24 Nov 2021
- Study completion24 Nov 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Mental HealthStudies of the same condition, open and under way.
- 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
- Double blind
- Who is masked
- Investigator, Outcomes assessor
- Enrolment
- 992 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Aarhus
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Lise Juul, PhD, Principal investigator, Danish Center for Mindfulness
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04610333
- Sponsor's protocol ID
- 15092020
- Status last verified
- Sep 2020
- First submitted
- 26 Oct 2020
- Last updated
- 26 Mar 2024
- Results posted
- No
- Data monitoring committee
- 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, Frydenberg M, Bonde EH, Beck MS, Goetzsche K, Bruggisser S, Fjorback LO. Introducing a mindfulness-based intervention in school curriculum to 16-24-year-olds. A nationwide cluster-randomized trial. Npj Ment Health Res. 2025 Aug 11;4(1):37. doi: 10.1038/s44184-025-00150-w.
PubMed 40789917Beck MS, Juul L, Frydenberg M, Fjorback LO. On Top of Everything: a study protocol for a cluster-randomised controlled trial testing a teacher training programme to teach mindfulness among students in Danish upper secondary schools and schools of health and social care. Trials. 2023 Jan 6;24(1):17. doi: 10.1186/s13063-022-06920-7.
PubMed 36609335
Study at a glance
From the registry record, last updated by the sponsor on 26 Mar 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- On Top of Everything. A Study Protocol for a Cluster-Randomised Controlled Trial Testing a Teacher Training Programme to Teach Mindfulness Among Students in Danish Upper Secondary Schools and Schools of Health and Social Care
- ClinicalTrials.gov ID
- NCT04610333
- Acronym / sponsor ID
- 15092020
- Conditions
- Mental Health, Youth, Mindfulness, Stress
- Keywords
- School-based intervention, Population-based preventive strategy, Public health
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 992 participants (actual)
- Lead sponsor
- University of AarhusUniversity, hospital or other
- Study start
- 13 Jan 2021 (actual)
- Primary completion
- 24 Nov 2021 (actual)
- Study completion
- 24 Nov 2021 (actual)
- First posted
- 30 Oct 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.
Our primary aim of this trial is to evaluate the effectiveness of a teacher training programme to teach mindfulness as part of regular classroom teaching in the total population of students in Danish upper secondary schools and schools of health and social care, respectively, on students' self-reported mental health at six-month follow-up.
Our secondary aim is to evaluate the effectiveness of the teacher training programme to teach mindfulness in a vulnerable subgroup of students on their self-reported mental health at three and six months after baseline.
Detailed description
The study is designed as a pragmatic cluster randomised two-arm trial including 43 Danish schools (30 upper secondary schools and 13 schools of health and social care). The schools included a total of 76 school teachers for teacher training (44 teachers from upper secondary schools and 32 teachers from schools of health and social care). Each included teacher will be asked to recruit a class of students (15-30 students) to test the effectiveness of the modified MBSR programme (in total approx. 1.000 students).
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| School teacher training | Experimental | Behavioral: Modified MBSR programmeTeacher training programme: * 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. * Four-day residental course * 3 x 2 seminar days Modified MBSR programme delivered to the students: - 1hour group session once a week in 10 weeks taught by the educated teachers on class |
| Usual practice | No intervention | – |
Who may qualify
- Ages
- 16 to 24 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult
Key inclusion criteria (1 listed)
- All students in the enrolled school classes
Key exclusion criteria (1 listed)
- None
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 |
|---|---|---|
| Modified MBSR programme1 hour group session once a week in 10 weeks | Behavioural | School teacher training |
Primary outcome
Warwick-Edinburgh Mental Well-Being Scale (SWEMWBS) - The short version
Time frame: Six months after baseline
Change in the score among the total study population
17 secondary outcomes
Warwick-Edinburgh Mental Well-Being Scale (SWEMWBS) - The short version
Time frame: Three months after baseline
Strengths and Difficulties Questionnaire (SDQ) - The youth self-report version
Time frame: Three months after baseline
Strengths and Difficulties Questionnaire (SDQ) - The youth self-report version
Time frame: Six months after baseline
Perseived Stress Scale
Time frame: Three months after baseline
Perseived Stress Scale
Time frame: Six months after baseline
Depression Anxiety Stress Scale (DASS) - The short form version
Time frame: Three months after baseline
Depression Anxiety Stress Scale (DASS) - The short form version
Time frame: Six months after baseline
Brief Resilience Scale (BRS)
Time frame: Three months after baseline
Brief Resilience Scale (BRS)
Time frame: Six months after baseline
Three-Item Loneliness Scale (T-ILS)
Time frame: Three months after baseline
Three-Item Loneliness Scale (T-ILS)
Time frame: Six months after baseline
Experiences Questionnaire (EQ) - Decentering subscale
Time frame: Three months after baseline
Experiences Questionnaire (EQ) - Decentering subscale
Time frame: Six months after baseline
EQ-5D
Time frame: Three months after baseline
EQ-5D
Time frame: Six months after baseline
Karolinska Sleep Questionnaire - Modified version
Time frame: Three months after baseline
Karolinska Sleep Questionnaire - Modified version
Time frame: Six months after 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 26 Mar 2024.
- Derived from this study: PubMed 40789917Juul L, Frydenberg M, Bonde EH, Beck MS, Goetzsche K, Bruggisser S, Fjorback LO. Introducing a mindfulness-based intervention in school curriculum to 16-24-year-olds. A nationwide cluster-randomized trial. Npj Ment Health Res. 2025 Aug 11;4(1):37. doi: 10.1038/s44184-025-00150-w.
- Derived from this study: PubMed 36609335Beck MS, Juul L, Frydenberg M, Fjorback LO. On Top of Everything: a study protocol for a cluster-randomised controlled trial testing a teacher training programme to teach mindfulness among students in Danish upper secondary schools and schools of health and social care. Trials. 2023 Jan 6;24(1):17. doi: 10.1186/s13063-022-06920-7.
- 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.
Lise Juul, PhD principal investigator
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 Modified MBSR programme in people with Mental Health and Youth, 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 1 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 26 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?
Warwick-Edinburgh Mental Well-Being Scale (SWEMWBS) - The short version (time frame: Six months after 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 NCT04610333, which also lists 2 linked publications.
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 26 Mar 2024.