NCT03886363

Brief Summary

The aim is to evaluate the effectiveness of Mindfulness-Based Stress Reduction among school teachers in Danish schools on mental weii-being in the teachers and their pupils. The study is a cluster-randomised trial including 150 schools; 200 teachers; 4000 pupils from the five geographical regions in Denmark.

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
200

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Dec 2018

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

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

December 18, 2018

Completed
3 months until next milestone

First Submitted

Initial submission to the registry

March 21, 2019

Completed
1 day until next milestone

First Posted

Study publicly available on registry

March 22, 2019

Completed
1.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 18, 2020

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 18, 2020

Completed
Last Updated

March 22, 2019

Status Verified

March 1, 2019

Enrollment Period

2 years

First QC Date

March 21, 2019

Last Update Submit

March 21, 2019

Conditions

Outcome Measures

Primary Outcomes (2)

  • Change in perceived stress among the school teachers

    Perceived Stress Scale

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

  • Change in resilience among the school teachers

    Brief Resilience Scale

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

Secondary Outcomes (7)

  • Change in symptoms of anxiety and depression among the school teachers

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

  • Change in well-being among the school teachers

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

  • Change in mindfulness among the school teachers

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

  • Change in resting state among the school teachers

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

  • Change in social capital among the pupils spending >5 hours with the teachers

    post MBSR (8 weeks from baseline)

  • +2 more secondary outcomes

Study Arms (2)

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: MBSR

Wait-list control

NO INTERVENTION

Usual practice

Interventions

MBSRBEHAVIORAL

Described previously

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 school that commit to participate in a trial aiming to implement and evaluate the effectiveness of ".b" (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

RECRUITING

Related Publications (1)

  • Juul L, Bonde EH, Fjorback LO. Altered self-reported resting state mediates the effects of Mindfulness-Based Stress Reduction on mental health: a longitudinal path model analysis within a community-based randomized trial with 6-months follow-up. Front Psychol. 2023 Jun 20;14:1154277. doi: 10.3389/fpsyg.2023.1154277. eCollection 2023.

MeSH Terms

Conditions

Psychological Well-Being

Condition Hierarchy (Ancestors)

Personal SatisfactionBehavior

Study Officials

  • Lone Fjorback, PhD

    Aarhus University, Danish Center for Mindfulness

    STUDY DIRECTOR

Central Study Contacts

Lise Juul, PhD, associate professor

CONTACT

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

March 21, 2019

First Posted

March 22, 2019

Study Start

December 18, 2018

Primary Completion

December 18, 2020

Study Completion

December 18, 2020

Last Updated

March 22, 2019

Record last verified: 2019-03

Locations