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On Top of Everything

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

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT04610333
Enrollment
992
Registered
2020-10-30
Start date
2021-01-13
Completion date
2021-11-24
Last updated
2024-03-26

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Mental Health, Mindfulness, Stress, Youth

Keywords

School-based intervention, Population-based preventive strategy, Public health

Brief 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 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).

Interventions

BEHAVIORALModified MBSR programme

1 hour group session once a week in 10 weeks

Sponsors

University of Aarhus
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
DOUBLE (Investigator, Outcomes Assessor)

Eligibility

Sex/Gender
ALL
Age
16 Years to 24 Years
Healthy volunteers
Yes

Inclusion criteria

* All students in the enrolled school classes

Exclusion criteria

* None

Design outcomes

Primary

MeasureTime frameDescription
Warwick-Edinburgh Mental Well-Being Scale (SWEMWBS) - The short versionSix months after baselineChange in the score among the total study population

Secondary

MeasureTime frameDescription
Strengths and Difficulties Questionnaire (SDQ) - The youth self-report versionThree months after baselineChange in the score among the total study population
Perseived Stress ScaleThree months after baselineChange in the score among the total study population
Depression Anxiety Stress Scale (DASS) - The short form versionThree months after baselineChange in the score among the total study population
Brief Resilience Scale (BRS)Three months after baselineChange in the score among the total study population
Warwick-Edinburgh Mental Well-Being Scale (SWEMWBS) - The short versionThree months after baselineChange in the score among the total study population
Experiences Questionnaire (EQ) - Decentering subscaleThree months after baselineChange in the score among the total study population
EQ-5DThree months after baselineChange in the score among the total study population
Karolinska Sleep Questionnaire - Modified versionThree months after baselineChange in the score among the total study population
Three-Item Loneliness Scale (T-ILS)Three months after baselineChange in the score among the total study population

Countries

Denmark

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 10, 2026