On Top of Everything

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

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.

Study Overview

• Status: Completed
• Conditions: Stress; Mental Health; Mindfulness; Youth
• Intervention / Treatment: Behavioral: Modified MBSR programme

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).

• Study Type: Interventional
• Enrollment (Actual): 992
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Denmark
  • Brabrand
    • Aarhus, Brabrand, Denmark, 8220
      • Danish Center for Mindfulness

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 16 years to 24 years (Child, Adult)
• Accepts Healthy Volunteers: Yes

Description

Inclusion Criteria:

• All students in the enrolled school classes

Exclusion Criteria:

• None

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: 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	Behavioral: Modified MBSR programme; 1 hour group session once a week in 10 weeks
No Intervention: Usual practice

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

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

Collaborators and Investigators

• Sponsor: University of Aarhus
• Investigators: Principal Investigator: Lise Juul, PhD, Danish Center for Mindfulness

Study record dates

Study Major Dates

• Study Start (Actual): January 13, 2021
• Primary Completion (Actual): November 24, 2021
• Study Completion (Actual): November 24, 2021

Study Registration Dates

• First Submitted: October 26, 2020
• First Submitted That Met QC Criteria: October 26, 2020
• First Posted (Actual): October 30, 2020

Study Record Updates

• Last Update Posted (Actual): March 26, 2024
• Last Update Submitted That Met QC Criteria: March 22, 2024
• Last Verified: September 1, 2020

More Information

Terms related to this study

• Keywords: School-based intervention; Public health; Population-based preventive strategy
• Other Study ID Numbers: 15092020

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: Individual deidentified participant data will be shared by reasonable request, following publication of planned papers.
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL; SAP; ICF

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No