On Top of Everything

Study Overview
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Brief Summary
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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
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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).

Official Title
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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

Conditions
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Mental Health, Youth, Mindfulness, Stress

Intervention / Treatment
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* Behavioral: Modified MBSR programme


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: All students in the enrolled school classes Exclusion Criteria: None

Ages Eligible for Study
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Minimum Age: 16 Years
Maximum Age: 24 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: School teacher training<br>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 | Behavioral: Modified MBSR programme<br>* 1 hour group session once a week in 10 weeks<br>|
| No Intervention: Usual practice<br> | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Warwick-Edinburgh Mental Well-Being Scale (SWEMWBS) - The short version | Change in the score among the total study population | Six months after baseline | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Warwick-Edinburgh Mental Well-Being Scale (SWEMWBS) - The short version | Change in the score among the total study population | Three months after baseline | 
| Strengths and Difficulties Questionnaire (SDQ) - The youth self-report version | Change in the score among the total study population | Three months after baseline | 
| Strengths and Difficulties Questionnaire (SDQ) - The youth self-report version | Change in the score among the total study population | Six months after baseline | 
| Perseived Stress Scale | Change in the score among the total study population | Three months after baseline | 
| Perseived Stress Scale | Change in the score among the total study population | Six months after baseline | 
| Depression Anxiety Stress Scale (DASS) - The short form version | Change in the score among the total study population | Three months after baseline | 
| Depression Anxiety Stress Scale (DASS) - The short form version | Change in the score among the total study population | Six months after baseline | 
| Brief Resilience Scale (BRS) | Change in the score among the total study population | Three months after baseline | 
| Brief Resilience Scale (BRS) | Change in the score among the total study population | Six months after baseline | 
| Three-Item Loneliness Scale (T-ILS) | Change in the score among the total study population | Three months after baseline | 
| Three-Item Loneliness Scale (T-ILS) | Change in the score among the total study population | Six months after baseline | 
| Experiences Questionnaire (EQ) - Decentering subscale | Change in the score among the total study population | Three months after baseline | 
| Experiences Questionnaire (EQ) - Decentering subscale | Change in the score among the total study population | Six months after baseline | 
| EQ-5D | Change in the score among the total study population | Three months after baseline | 
| EQ-5D | Change in the score among the total study population | Six months after baseline | 
| Karolinska Sleep Questionnaire - Modified version | Change in the score among the total study population | Three months after baseline | 
| Karolinska Sleep Questionnaire - Modified version | Change in the score among the total study population | Six months after baseline | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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School-based intervention, Population-based preventive strategy, Public health