NCT04558099

Brief Summary

The aim is to evaluate the effectiveness of Mindfulness-based Stress Reduction among Danish student teachers on their mental well-being. The study is a randomised, controlled trial including 100 teachers.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
67

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Sep 2019

Geographic Reach
1 country

1 active site

Status
completed

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

September 1, 2019

Completed
1 year 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
4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 12, 2021

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 12, 2021

Completed
Last Updated

March 22, 2024

Status Verified

July 1, 2020

Enrollment Period

1.4 years

First QC Date

September 16, 2020

Last Update Submit

March 21, 2024

Conditions

Outcome Measures

Primary Outcomes (1)

  • Perceived Stress Scale

    Change in perceived stress among the student teachers

    2 months from baseline

Secondary Outcomes (5)

  • Brief Resilience Scale Brief Resilience Scale Brief Resilience Scale Brief Resilience Scale

    post MBSR (8 weeks from baseline)

  • Symptom Check List - 5

    post MBSR (8 weeks from baseline)

  • WHO-5

    post MBSR (8 weeks from baseline)

  • Five Facet Mindfulness Questionnaire-15

    post MBSR (8 weeks from baseline)

  • Amsterdam Resting State Questionnaire

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

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

Age16 Years - 40 Years
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64)

You may qualify if:

  • Danish student teacher

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)

Aarhus University, Department of Clinical Medicine, Danish Center for Mindfulness

Aarhus, 8220, Denmark

Location

Related Publications (1)

  • Juul L, Brorsen E, Gotzsche K, Nielsen BL, Fjorback LO. The Effects of a Mindfulness Program on Mental Health in Students at an Undergraduate Program for Teacher Education: A Randomized Controlled Trial in Real-Life. Front Psychol. 2021 Dec 6;12:722771. doi: 10.3389/fpsyg.2021.722771. eCollection 2021.

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

September 1, 2019

Primary Completion

January 12, 2021

Study Completion

January 12, 2021

Last Updated

March 22, 2024

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.

Locations