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Completed

NCT Number: NCT04610333

On Top of Everything

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.

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Key information

Conditions

Mental Health Behavior Mindfulness Personal Satisfaction Psychological Well-Being Stress Youth

Age range

16 year–24 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Danish Center for Mindfulness

Aarhus, Brabrand, 8220, Denmark

About this study

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).

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • All students in the enrolled school classes

Exclusion criteria

  • None

Treatment and study plan

Modified MBSR programme

Behavioral

1 hour group session once a week in 10 weeks

Primary outcomes

  1. 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

  1. Warwick-Edinburgh Mental Well-Being Scale (SWEMWBS) - The short version

    Time frame: Three months after baseline

    Change in the score among the total study population

  2. Strengths and Difficulties Questionnaire (SDQ) - The youth self-report version

    Time frame: Three months after baseline

    Change in the score among the total study population

  3. Strengths and Difficulties Questionnaire (SDQ) - The youth self-report version

    Time frame: Six months after baseline

    Change in the score among the total study population

  4. Perseived Stress Scale

    Time frame: Three months after baseline

    Change in the score among the total study population

  5. Perseived Stress Scale

    Time frame: Six months after baseline

    Change in the score among the total study population

  6. Depression Anxiety Stress Scale (DASS) - The short form version

    Time frame: Three months after baseline

    Change in the score among the total study population

  7. Depression Anxiety Stress Scale (DASS) - The short form version

    Time frame: Six months after baseline

    Change in the score among the total study population

  8. Brief Resilience Scale (BRS)

    Time frame: Three months after baseline

    Change in the score among the total study population

  9. Brief Resilience Scale (BRS)

    Time frame: Six months after baseline

    Change in the score among the total study population

  10. Three-Item Loneliness Scale (T-ILS)

    Time frame: Three months after baseline

    Change in the score among the total study population

  11. Three-Item Loneliness Scale (T-ILS)

    Time frame: Six months after baseline

    Change in the score among the total study population

  12. Experiences Questionnaire (EQ) - Decentering subscale

    Time frame: Three months after baseline

    Change in the score among the total study population

  13. Experiences Questionnaire (EQ) - Decentering subscale

    Time frame: Six months after baseline

    Change in the score among the total study population

  14. EQ-5D

    Time frame: Three months after baseline

    Change in the score among the total study population

  15. EQ-5D

    Time frame: Six months after baseline

    Change in the score among the total study population

  16. Karolinska Sleep Questionnaire - Modified version

    Time frame: Three months after baseline

    Change in the score among the total study population

  17. Karolinska Sleep Questionnaire - Modified version

    Time frame: Six months after baseline

    Change in the score among the total study population

Sponsors and collaborators

Lead sponsor

University of Aarhus

Other

Registry information

Official study 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

Important dates

Study start
2021
Primary completion
2021
Study completion
2021
First posted
Oct 30, 2020
Registry last updated
Mar 26, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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