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Clinical Trials/NCT04610333
NCT04610333
Completed
Not Applicable

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

University of Aarhus1 site in 1 country992 target enrollmentJanuary 13, 2021

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Mental Health
Sponsor
University of Aarhus
Enrollment
992
Locations
1
Primary Endpoint
Warwick-Edinburgh Mental Well-Being Scale (SWEMWBS) - The short version
Status
Completed
Last Updated
2 years ago

Overview

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).

Registry
clinicaltrials.gov
Start Date
January 13, 2021
End Date
November 24, 2021
Last Updated
2 years ago
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Responsible Party
Sponsor

Eligibility Criteria

Inclusion Criteria

  • All students in the enrolled school classes

Exclusion Criteria

  • Not provided

Outcomes

Primary Outcomes

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

Secondary Outcomes

  • Depression Anxiety Stress Scale (DASS) - The short form version(Six months after baseline)
  • Three-Item Loneliness Scale (T-ILS)(Six months after baseline)
  • Experiences Questionnaire (EQ) - Decentering subscale(Six months after baseline)
  • Warwick-Edinburgh Mental Well-Being Scale (SWEMWBS) - The short version(Three months after baseline)
  • Strengths and Difficulties Questionnaire (SDQ) - The youth self-report version(Six months after baseline)
  • Perseived Stress Scale(Six months after baseline)
  • Brief Resilience Scale (BRS)(Six months after baseline)
  • EQ-5D(Six months after baseline)
  • Karolinska Sleep Questionnaire - Modified version(Six months after baseline)

Study Sites (1)

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