On Top of Everything

Stress Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04610333
• Other study ID #: 15092020
• Status: Completed
• Phase: N/A
• Start date: January 13, 2021
• Est. completion date: November 24, 2021

Study information

• Verified date: September 2020
• Source: University of Aarhus
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 992
• Est. completion date: November 24, 2021
• Est. primary completion date: November 24, 2021
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 16 Years to 24 Years

Eligibility

Inclusion Criteria:

• All students in the enrolled school classes

Exclusion Criteria:

• None

Related Conditions & MeSH terms

• Mental Health
• Mindfulness
• Stress
• Youth

Intervention

Behavioral:
• Modified MBSR programme
1 hour group session once a week in 10 weeks

Locations

Country	Name	City	State
Denmark	Danish Center for Mindfulness	Aarhus	Brabrand

Sponsors (1)

Lead Sponsor	Collaborator
University of Aarhus

Country where clinical trial is conducted

Denmark, 

Outcome

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