On Top of Everything

Not Applicable

Completed

• Conditions: Mindfulness; Mental Health; Stress; Youth
• Interventions: Behavioral: Modified MBSR programme

• Registration Number: NCT04610333
• Lead Sponsor: University of Aarhus

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).

Basic Information
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Recruitment & Eligibility
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Study & Design
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Trial Locations

Study Timeline

• Status Verified: 2020-09
• Study First Submitted: 2020-10-26
• Study First Submitted QC: 2020-10-26
• Study First Posted: 2020-10-30
• Study Start: 2021-01-13
• Primary Completion: 2021-11-24
• Study Completion: 2021-11-24
• Last Update Submitted: 2024-03-22
• Last Update Posted: 2024-03-26

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 992

Inclusion Criteria

• All students in the enrolled school classes

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Exclusion Criteria

• None

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
School teacher training	Modified MBSR programme	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

Primary Outcome Measures

Name	Time	Method
Warwick-Edinburgh Mental Well-Being Scale (SWEMWBS) - The short version	Six months after baseline	Change in the score among the total study population

Secondary Outcome Measures

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

Trial Locations

Locations (1)

Danish Center for Mindfulness; 🇩🇰 Aarhus, Brabrand, Denmark