On Top of Everything

NCT ID: NCT04610333

Last Updated: 2024-03-26

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 992 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2021-01-13
• Study Completion Date: 2021-11-24

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).

Conditions

Mental Health; Youth; Mindfulness; Stress

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: PREVENTION
• Blinding Strategy: DOUBLE

Study Groups

School teacher training

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

Group Type: EXPERIMENTAL

Modified MBSR programme

Intervention Type: BEHAVIORAL

1 hour group session once a week in 10 weeks

Usual practice

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

Modified MBSR programme

1 hour group session once a week in 10 weeks

Intervention Type: BEHAVIORAL

Eligibility Criteria

Inclusion Criteria

• All students in the enrolled school classes

Exclusion Criteria

• None

• Minimum Eligible Age: 16 Years
• Maximum Eligible Age: 24 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

University of Aarhus

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Lise Juul, PhD

Role: PRINCIPAL_INVESTIGATOR

Danish Center for Mindfulness

Locations

Danish Center for Mindfulness

Aarhus, Brabrand, Denmark

Countries

Denmark

References

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.

Reference Type: DERIVED

PMID: 40789917 (View on PubMed)

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.

Reference Type: DERIVED

PMID: 36609335 (View on PubMed)

Other Identifiers

15092020

Identifier Type: -

Identifier Source: org_study_id