On Top of Everything

• Sponsor: University of Aarhus (Other)
• Overall Status: Recruiting
• CT.gov ID: NCT04610333
• Collaborator: (none)
• Enrollment: 1,000
• Location: 1
• Arms: 2
• Anticipated Duration (Months): 9.6
• Patients Per Site Per Month: 104.2

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Mental Health; Youth; Mindfulness; Stress	Behavioral: Modified MBSR programme	N/A

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 Design

• Study Type: Interventional
• Anticipated Enrollment: 1000 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Double (Investigator, Outcomes Assessor)
• Primary Purpose: Prevention
• Official 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
• Actual Study Start Date: Jan 13, 2021
• Anticipated Primary Completion Date: Nov 1, 2021
• Anticipated Study Completion Date: Nov 1, 2021

Arms and Interventions

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

Outcome Measures

Primary Outcome Measures

1. 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

1. Warwick-Edinburgh Mental Well-Being Scale (SWEMWBS) - The short version [Three months after baseline]

   Change in the score among the total study population

2. Strengths and Difficulties Questionnaire (SDQ) - The youth self-report version [Three months after baseline]

   Change in the score among the total study population

3. Strengths and Difficulties Questionnaire (SDQ) - The youth self-report version [Six months after baseline]

   Change in the score among the total study population

4. Perseived Stress Scale [Three months after baseline]

   Change in the score among the total study population

5. Perseived Stress Scale [Six months after baseline]

   Change in the score among the total study population

6. Depression Anxiety Stress Scale (DASS) - The short form version [Three months after baseline]

   Change in the score among the total study population

7. Depression Anxiety Stress Scale (DASS) - The short form version [Six months after baseline]

   Change in the score among the total study population

8. Brief Resilience Scale (BRS) [Three months after baseline]

   Change in the score among the total study population

9. Brief Resilience Scale (BRS) [Six months after baseline]

   Change in the score among the total study population

10. Three-Item Loneliness Scale (T-ILS) [Three months after baseline]

    Change in the score among the total study population

11. Three-Item Loneliness Scale (T-ILS) [Six months after baseline]

    Change in the score among the total study population

12. Experiences Questionnaire (EQ) - Decentering subscale [Three months after baseline]

    Change in the score among the total study population

13. Experiences Questionnaire (EQ) - Decentering subscale [Six months after baseline]

    Change in the score among the total study population

14. EQ-5D [Three months after baseline]

    Change in the score among the total study population

15. EQ-5D [Six months after baseline]

    Change in the score among the total study population

16. Karolinska Sleep Questionnaire - Modified version [Three months after baseline]

    Change in the score among the total study population

17. Karolinska Sleep Questionnaire - Modified version [Six months after baseline]

    Change in the score among the total study population

Eligibility Criteria

Criteria

• Ages Eligible for Study: 16 Years to 24 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: Yes

Inclusion Criteria:

• All students in the enrolled school classes

Exclusion Criteria:

• None

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Danish Center for Mindfulness	Aarhus	Brabrand	Denmark	8220

Sponsors and Collaborators

• University of Aarhus

Investigators

• Principal Investigator: Lise Juul, PhD, Danish Center for Mindfulness

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: University of Aarhus
• ClinicalTrials.gov Identifier: NCT04610333
• Other Study ID Numbers: 15092020
• First Posted: Oct 30, 2020
• Last Update Posted: May 4, 2021
• Last Verified: Sep 1, 2020

• Individual Participant Data (IPD) Sharing Statement: Yes
• Plan to Share IPD: Yes
• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Keywords provided by University of Aarhus: School-based intervention; Population-based preventive strategy; Public health

Study Results

No Results Posted as of May 4, 2021