NCT04558008

Brief Summary

The aim is to evaluate the effectiveness of online Mindfulness-based Stress Reduction among school teachers in Danish upper secondary schools and schools of health and social care on mental well-being in the teachers and their students. The study is a cluster-randomised trial including 43 schools; 76 teachers; 1.000 students.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
76

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Oct 2019

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

October 28, 2019

Completed
11 months until next milestone

First Submitted

Initial submission to the registry

September 16, 2020

Completed
6 days until next milestone

First Posted

Study publicly available on registry

September 22, 2020

Completed
1.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 28, 2021

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

October 28, 2021

Completed
Last Updated

September 22, 2020

Status Verified

July 1, 2020

Enrollment Period

2 years

First QC Date

September 16, 2020

Last Update Submit

September 16, 2020

Conditions

Outcome Measures

Primary Outcomes (1)

  • Perceived Stress Scale

    Change in perceived stress among the school teachers

    6 months from baseline

Secondary Outcomes (6)

  • Perceived Stress Scale

    post MBSR (8 weeks from baseline) and 12 months from baseline

  • Brief Resilience Scale

    post MBSR (8 weeks from baseline), 6 and 12 months from baseline

  • Symptom Check List - 5

    post MBSR (8 weeks from baseline), 6 and 12 months from baseline

  • WHO-5

    post MBSR (8 weeks from baseline), 6 and 12 months from baseline

  • Five Facet Mindfulness Questionnaire-15

    post MBSR (8 weeks from baseline), 6 and 12 months from baseline

  • +1 more secondary outcomes

Study Arms (2)

Online MBSR

EXPERIMENTAL

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.

Behavioral: Online MBSR

Wait-list control

NO INTERVENTION

Usual practice

Interventions

Online MBSRBEHAVIORAL

Described previously

Online MBSR

Eligibility Criteria

Sexall
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • School teacher at a Danish upper secondary school or school of health and social care that commit to participate in a trial aiming to implement and evaluate the effectiveness of a school-based mindfulness programme.

You may not qualify if:

  • acute treatment-demanding clinical depression or a diagnosis of psychosis or schizophrenia
  • abuse of alcohol, drugs, medicine

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Danish Center for Mindfulness

Aarhus, 8220, Denmark

Location

MeSH Terms

Conditions

Psychological Well-Being

Condition Hierarchy (Ancestors)

Personal SatisfactionBehavior

Study Officials

  • Lone Fjorback, PhD, MD

    Aarhus University, Danish Center for Mindfulness

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
INVESTIGATOR
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

September 16, 2020

First Posted

September 22, 2020

Study Start

October 28, 2019

Primary Completion

October 28, 2021

Study Completion

October 28, 2021

Last Updated

September 22, 2020

Record last verified: 2020-07

Data Sharing

IPD Sharing
Will share

Individual deidentified participant data will be shared by reasonable request, following publication of planned papers.

Shared Documents
STUDY PROTOCOL, SAP

Locations