On Top of Everything

NCT04610333 | Completed

• 1 other identifier: 15092020
• Study Type: interventional
• Target: 992
• Locations: 1 country
• Sites: 1

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.

Conditions

Mental Health; Youth; Mindfulness; Stress

Keywords

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

Outcome Measures

Primary Outcomes (1)

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

  Change in the score among the total study population

  Six months after baseline

Secondary Outcomes (17)

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

  Three months after baseline

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

  Three months after baseline

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

  Six months after baseline

• Perseived Stress Scale

  Three months after baseline

• Perseived Stress Scale

  Six months after baseline

Study Arms (2)

School teacher training

EXPERIMENTAL

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

Usual practice

NO INTERVENTION

Interventions

Modified MBSR programme BEHAVIORAL

1 hour group session once a week in 10 weeks

School teacher training

Eligibility Criteria

• Age: 16 Years - 24 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• All students in the enrolled school classes

You may not qualify if:

• None

Sponsors & Collaborators

• University of Aarhus: lead

Study Sites (1)

Danish Center for Mindfulness

Aarhus, Brabrand, 8220, Denmark

Location

Related Publications (2)

• Juul L, Frydenberg M, Bonde EH, Beck MS, Goetzsche K, Bruggisser S, Fjorback LO. Introducing a mindfulness-based intervention in school curriculum to 16-24-year-olds. A nationwide cluster-randomized trial. Npj Ment Health Res. 2025 Aug 11;4(1):37. doi: 10.1038/s44184-025-00150-w.

  PMID: 40789917 DERIVED

• Beck MS, Juul L, Frydenberg M, Fjorback LO. 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. Trials. 2023 Jan 6;24(1):17. doi: 10.1186/s13063-022-06920-7.

  PMID: 36609335 DERIVED

MeSH Terms

Conditions

Psychological Well-Being

Condition Hierarchy (Ancestors)

Personal Satisfaction; Behavior

Study Officials

• Lise Juul, PhD

  Danish Center for Mindfulness

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 26, 2020
• First Posted: October 30, 2020
• Study Start: January 13, 2021
• Primary Completion: November 24, 2021
• Study Completion: November 24, 2021
• Last Updated: March 26, 2024

Record last verified: 2020-09

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF

Locations

DK (1)