NCT03969771

Brief Summary

This study will evaluate the effectiveness of an 8-week program in Mindfulness-Based Stress Reduction (MBSR) in reducing work absences and improving the well-being of healthcare workers. Half of participants will be healthcare employees who are frequently absent from work, whereas the other half will be healthcare employees with normal attendance patterns. All participants will undergo MBSR training and the outcomes of both groups will be evaluated.

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
120

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Jun 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

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

May 24, 2019

Completed
7 days until next milestone

First Posted

Study publicly available on registry

May 31, 2019

Completed
24 days until next milestone

Study Start

First participant enrolled

June 24, 2019

Completed
2.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2021

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2021

Completed
Last Updated

June 25, 2019

Status Verified

June 1, 2019

Enrollment Period

2.2 years

First QC Date

May 24, 2019

Last Update Submit

June 24, 2019

Conditions

Keywords

Mindfulness-Based Stress ReductionMindfulness

Outcome Measures

Primary Outcomes (1)

  • Change in the Number of Work Absences

    A comparison between the number of work absences in the 2 years prior versus 2 years following the intervention. The desired outcome is a statistically significant decrease in the number of work absences.

    Baseline and 2 years

Secondary Outcomes (11)

  • Change in the Number of Workplace Accidents and Injuries

    Baseline and 2 years

  • Change in the Number of Late Work Arrivals

    Baseline and 2 years

  • Change in Perceived Stress

    Baseline and 8 weeks

  • Change in Burnout

    Baseline and 8 weeks

  • Change in Positive and Negative Emotions

    Baseline and 8 weeks

  • +6 more secondary outcomes

Study Arms (2)

Frequently Absent

EXPERIMENTAL

8 weeks of training in Mindfulness-Based Stress Reduction

Behavioral: Mindfulness-Based Stress Reduction (MBSR)

Normal Attendees (Controls)

ACTIVE COMPARATOR

8 weeks of training in Mindfulness-Based Stress Reduction

Behavioral: Mindfulness-Based Stress Reduction (MBSR)

Interventions

The MBSR program was developed by the University of Massachusetts Medical School.

Frequently AbsentNormal Attendees (Controls)

Eligibility Criteria

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

You may qualify if:

  • An employee of Actionmarguerite or St. Amant Centre in Winnipeg, Manitoba, Canada who has contact with patients.

You may not qualify if:

  • None.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

St. Boniface Hospital Research Centre

Winnipeg, Manitoba, R2H 2A6, Canada

RECRUITING

MeSH Terms

Conditions

Stress, PsychologicalBurnout, ProfessionalBurnout, Psychological

Interventions

Mindfulness-Based Stress Reduction

Condition Hierarchy (Ancestors)

Behavioral SymptomsBehaviorOccupational StressOccupational Diseases

Intervention Hierarchy (Ancestors)

MindfulnessCognitive Behavioral TherapyBehavior TherapyPsychotherapyBehavioral Disciplines and Activities

Study Officials

  • Michael McIntyre, Ph.D.

    St. Boniface Hospital Research Centre

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Michael McIntyre, Ph.D.

CONTACT

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Model Details: 2 x 2 Mixed Factorial Design, with Group (frequently absent / control) as the between-subjects factor and Time (pre / post) as the within-subjects factor.
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

May 24, 2019

First Posted

May 31, 2019

Study Start

June 24, 2019

Primary Completion

September 1, 2021

Study Completion

September 1, 2021

Last Updated

June 25, 2019

Record last verified: 2019-06

Data Sharing

IPD Sharing
Will not share

Locations