Effectiveness of MBSR Among Student Teachers

• Sponsor: University of Aarhus (Other)
• Overall Status: Completed
• CT.gov ID: NCT04558099
• Collaborator: (none)
• Enrollment: 67
• Location: 1
• Arms: 2
• Actual Duration (Months): 16.4
• Patients Per Site Per Month: 4.1

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Stress Reduction; Mental Well-being	Behavioral: MBSR	N/A

Study Design

• Study Type: Interventional
• Actual Enrollment: 67 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Single (Investigator)
• Primary Purpose: Prevention
• Official Title: Effectiveness of Mindfulness-based Stress Reduction Among Student Teachers
• Actual Study Start Date: Sep 1, 2019
• Actual Primary Completion Date: Jan 12, 2021
• Actual Study Completion Date: Jan 12, 2021

Arms and Interventions

Arm	Intervention/Treatment
Experimental: MBSR 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; Described previously
No Intervention: Wait-list control Usual practice

Outcome Measures

Primary Outcome Measures

1. Perceived Stress Scale [2 months from baseline]

   Change in perceived stress among the student teachers

Secondary Outcome Measures

1. Brief Resilience Scale Brief Resilience Scale Brief Resilience Scale Brief Resilience Scale [post MBSR (8 weeks from baseline)]

   Change in resilience among the student teachers

2. Symptom Check List - 5 [post MBSR (8 weeks from baseline)]

   Change in symptoms of anxiety and depression among the student teachers

3. WHO-5 [post MBSR (8 weeks from baseline)]

   Change in well-being among the student teachers

4. Five Facet Mindfulness Questionnaire-15 [post MBSR (8 weeks from baseline)]

   Change in mindfulness among the student teachers

5. Amsterdam Resting State Questionnaire [post MBSR (8 weeks from baseline), 6 and 12 months from baseline]

   Change in resting state among the student teachers

Eligibility Criteria

Criteria

• Ages Eligible for Study: N/A and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: Yes

Inclusion Criteria:

• Danish student teacher

Exclusion Criteria:

• acute treatment-demanding clinical depression or a diagnosis of psychosis or schizophrenia

• abuse of alcohol, drugs, medicine

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Aarhus University, Department of Clinical Medicine, Danish Center for Mindfulness	Aarhus		Denmark	8220

Sponsors and Collaborators

• University of Aarhus

Investigators

• Study Director: Lone Fjorback, PhD, MD, Aarhus University, Danish Center for Mindfulness

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: University of Aarhus
• ClinicalTrials.gov Identifier: NCT04558099
• Other Study ID Numbers: 08072020
• First Posted: Sep 22, 2020
• Last Update Posted: Apr 19, 2021
• Last Verified: Jul 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

Study Results

No Results Posted as of Apr 19, 2021