A Mindfulness Based Intervention as a Key Component of Successful Workplace Functioning and Personal Well-being
Primary Purpose
Emotional Stress, Work Related Illnesses, Burnout, Professional
Status
Unknown status
Phase
Not Applicable
Locations
Canada
Study Type
Interventional
Intervention
Mindfulness-Based Stress Reduction (MBSR)
Sponsored by
About this trial
This is an interventional treatment trial for Emotional Stress focused on measuring Mindfulness-Based Stress Reduction, Mindfulness
Eligibility Criteria
Inclusion Criteria:
- An employee of Actionmarguerite or St. Amant Centre in Winnipeg, Manitoba, Canada who has contact with patients.
Exclusion Criteria:
- None.
Sites / Locations
- St. Boniface Hospital Research CentreRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
Frequently Absent
Normal Attendees (Controls)
Arm Description
8 weeks of training in Mindfulness-Based Stress Reduction
8 weeks of training in Mindfulness-Based Stress Reduction
Outcomes
Primary Outcome Measures
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.
Secondary Outcome Measures
Change in the Number of Workplace Accidents and Injuries
A comparison between the number of workplace accidents and injuries in the 2 years prior versus 2 years following the intervention. The desired outcome is a statistically significant decrease in the number of workplace accidents and injuries.
Change in the Number of Late Work Arrivals
A comparison between the number of late work arrivals in the 2 years prior versus 2 years following the intervention. The desired outcome is a statistically significant decrease in the number of late work arrivals.
Change in Perceived Stress
Assessed by total scores on the Perceived Stress Scale (Cohen et al., 1983), which range from 1 to 5 when item scores are averaged. The desired outcome is a statistically significant decrease in perceived stress.
Change in Burnout
Assessed by total scores and subscale scores (personal burnout, work burnout, client burnout) on the Copenhagen Burnout Inventory (Kristensen et al., 2005), which range from 1 to 5 when item scores are averaged. The desired outcome is a statistically significant decrease in burnout.
Change in Positive and Negative Emotions
Assessed by subscale scores (positive affect, negative affect) on the Positive and Negative Affect Schedule (Watson et al., 1988), which range from 1 to 5 when item scores are averaged. The desired outcome is a statistically significant increase in positive emotions and a statistically significant decrease in negative emotions.
Change in Anxiety
Assessed by total scores on the State-Trait Anxiety Inventory (Spielberger, 1983), which range from 1 to 4 when item scores are averaged. The desired outcome is a statistically significant decrease in anxiety.
Change in Health Locus of Control
Assessed by subscale scores (internal, chance, powerful others) on the Multidimensional Health Locus of Control Scale (Wallston et al., 1978), which range from 1 to 6 when item scores are averaged. The desired outcome is a statistically significant increase in internal health locus of control.
Change in Workplace Deviance
Assessed by total scores on the Workplace Deviance Scale (Bennett & Robinson, 2000), which range from 1 to 7 when item scores are averaged. The desired outcome is a statistically significant decrease in workplace deviance.
Change in Mindfulness
Assessed by total scores and subscale scores on the Five Facet Mindfulness Questionnaire (Baer et al., 2006), which range from 1 to 5 when item scores are averaged. The desired outcome is a statistically significant increase in mindfulness.
Change in Self-Compassion
Assessed by total scores and subscale scores on the Self-Compassion Scale (Neff, 2003), which range from 1 to 5 when item scores are averaged. The desired outcome is a statistically significant increase in self-compassion.
Change in Fears of Compassion
Assessed by total scores and subscale scores on the Fears of Compassion Scales (Gilbert et al., 2011), which range from 0 to 4 when item scores are averaged. The desired outcome is a statistically significant decrease in fears of compassion.
Full Information
NCT ID
NCT03969771
First Posted
May 24, 2019
Last Updated
June 24, 2019
Sponsor
University of Manitoba
Collaborators
Workers Compensation Board of Manitoba, Catholic Health Corporation of Manitoba
1. Study Identification
Unique Protocol Identification Number
NCT03969771
Brief Title
A Mindfulness Based Intervention as a Key Component of Successful Workplace Functioning and Personal Well-being
Official Title
A Mindfulness Based Intervention as a Key Component of Successful Workplace Functioning and Personal Well-being
Study Type
Interventional
2. Study Status
Record Verification Date
June 2019
Overall Recruitment Status
Unknown status
Study Start Date
June 24, 2019 (Actual)
Primary Completion Date
September 1, 2021 (Anticipated)
Study Completion Date
September 1, 2021 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Manitoba
Collaborators
Workers Compensation Board of Manitoba, Catholic Health Corporation of Manitoba
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
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.
Detailed Description
The scientific literature is replete with evidence that the demands and pace of providing healthcare is associated with high levels of stress, anxiety, burnout, diminished work engagement, and frequent absence. For example, Actionmarguerite is one of the largest personal care facilities in Western Canada. They have over 500 employees who routinely deal with the task of providing care to a large population of individuals requiring high levels of support. A great many of the residents are suffering progressive dementia and some have very difficult behavioural issues. Caretaker stress is exacerbated by the fact that even the highest, most compassionate levels of care are not likely to result in improvement. The employee population is, therefore, taxed such that one might expect to observe a high level of stress-related illness and accidents. An internal examination of the employee database has identified an interesting circumstance. Approximately fifty of the employees have patterns of persistent, recurring injury, show signs of stress/caretaker stress, depletion, and preoccupation. This group has also largely exhausted their sick leave benefits. Clearly, the medical treatments and the time away from work have not cured the underlying predisposition for accidental injury and illness for these individuals. Such may be the case for employees of other healthcare facilities in Canada and elsewhere.
The question has arisen whether Mindfulness Based Stress Reduction (MBSR) as an option available for frequently absent employees would alter the pattern of recurrence and reduce stress. MBSR is a program initially developed at the University of Massachusetts Medical Centre as a means of reducing the chronic stress of patients experiencing high levels of disabling, chronic physical pain. Scientific evaluation of the program demonstrated significant success. Importantly, MBSR training has been shown to reduce stress and anxiety and promote psychological well-being, both for individuals in the general population and for healthcare workers in particular. Indeed, our own work has demonstrated that MBSR resulted in a very substantial and statistically significant reduction of stress in a diverse group of individuals employed in healthcare.
The purpose of the present research is to examine the efficacy of a program of MBSR to interrupt the existing pattern of recurrent work-related accidents, injuries, and illness; and also, to promote both psychological and physical well-being and to allow a more meaningful and successful return to work. We intend to recruit four groups of thirty participants from two local healthcare institutions (Actionmarguerite and St. Amant). Each group will consist of (a) fifteen individuals identified by the respective institutions as frequently-absent employees, and (b) fifteen individuals who express interest in participation and are randomly selected from the general population of healthcare employees at the two institutions to serve as statistical controls. All participants will receive an intervention of MBSR training. They will complete a survey battery both pre- and post- intervention and provide access to their work histories. We hope to establish that MBSR can be an extremely useful component of a program intended to reverse patterns of frequent absence.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Emotional Stress, Work Related Illnesses, Burnout, Professional, Burnout Syndrome
Keywords
Mindfulness-Based Stress Reduction, Mindfulness
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
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.
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
120 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Frequently Absent
Arm Type
Experimental
Arm Description
8 weeks of training in Mindfulness-Based Stress Reduction
Arm Title
Normal Attendees (Controls)
Arm Type
Active Comparator
Arm Description
8 weeks of training in Mindfulness-Based Stress Reduction
Intervention Type
Behavioral
Intervention Name(s)
Mindfulness-Based Stress Reduction (MBSR)
Intervention Description
The MBSR program was developed by the University of Massachusetts Medical School.
Primary Outcome Measure Information:
Title
Change in the Number of Work Absences
Description
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.
Time Frame
Baseline and 2 years
Secondary Outcome Measure Information:
Title
Change in the Number of Workplace Accidents and Injuries
Description
A comparison between the number of workplace accidents and injuries in the 2 years prior versus 2 years following the intervention. The desired outcome is a statistically significant decrease in the number of workplace accidents and injuries.
Time Frame
Baseline and 2 years
Title
Change in the Number of Late Work Arrivals
Description
A comparison between the number of late work arrivals in the 2 years prior versus 2 years following the intervention. The desired outcome is a statistically significant decrease in the number of late work arrivals.
Time Frame
Baseline and 2 years
Title
Change in Perceived Stress
Description
Assessed by total scores on the Perceived Stress Scale (Cohen et al., 1983), which range from 1 to 5 when item scores are averaged. The desired outcome is a statistically significant decrease in perceived stress.
Time Frame
Baseline and 8 weeks
Title
Change in Burnout
Description
Assessed by total scores and subscale scores (personal burnout, work burnout, client burnout) on the Copenhagen Burnout Inventory (Kristensen et al., 2005), which range from 1 to 5 when item scores are averaged. The desired outcome is a statistically significant decrease in burnout.
Time Frame
Baseline and 8 weeks
Title
Change in Positive and Negative Emotions
Description
Assessed by subscale scores (positive affect, negative affect) on the Positive and Negative Affect Schedule (Watson et al., 1988), which range from 1 to 5 when item scores are averaged. The desired outcome is a statistically significant increase in positive emotions and a statistically significant decrease in negative emotions.
Time Frame
Baseline and 8 weeks
Title
Change in Anxiety
Description
Assessed by total scores on the State-Trait Anxiety Inventory (Spielberger, 1983), which range from 1 to 4 when item scores are averaged. The desired outcome is a statistically significant decrease in anxiety.
Time Frame
Baseline and 8 weeks
Title
Change in Health Locus of Control
Description
Assessed by subscale scores (internal, chance, powerful others) on the Multidimensional Health Locus of Control Scale (Wallston et al., 1978), which range from 1 to 6 when item scores are averaged. The desired outcome is a statistically significant increase in internal health locus of control.
Time Frame
Baseline and 8 weeks
Title
Change in Workplace Deviance
Description
Assessed by total scores on the Workplace Deviance Scale (Bennett & Robinson, 2000), which range from 1 to 7 when item scores are averaged. The desired outcome is a statistically significant decrease in workplace deviance.
Time Frame
Baseline and 8 weeks
Title
Change in Mindfulness
Description
Assessed by total scores and subscale scores on the Five Facet Mindfulness Questionnaire (Baer et al., 2006), which range from 1 to 5 when item scores are averaged. The desired outcome is a statistically significant increase in mindfulness.
Time Frame
Baseline and 8 weeks
Title
Change in Self-Compassion
Description
Assessed by total scores and subscale scores on the Self-Compassion Scale (Neff, 2003), which range from 1 to 5 when item scores are averaged. The desired outcome is a statistically significant increase in self-compassion.
Time Frame
Baseline and 8 weeks
Title
Change in Fears of Compassion
Description
Assessed by total scores and subscale scores on the Fears of Compassion Scales (Gilbert et al., 2011), which range from 0 to 4 when item scores are averaged. The desired outcome is a statistically significant decrease in fears of compassion.
Time Frame
Baseline and 8 weeks
10. Eligibility
Sex
All
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria:
An employee of Actionmarguerite or St. Amant Centre in Winnipeg, Manitoba, Canada who has contact with patients.
Exclusion Criteria:
None.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Michael McIntyre, Ph.D.
Phone
1-204-235-3206
Email
mmcintyre@sbrc.ca
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Michael McIntyre, Ph.D.
Organizational Affiliation
St. Boniface Hospital Research Centre
Official's Role
Principal Investigator
Facility Information:
Facility Name
St. Boniface Hospital Research Centre
City
Winnipeg
State/Province
Manitoba
ZIP/Postal Code
R2H 2A6
Country
Canada
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Michael McIntyre, Ph.D.
Phone
1-204-235-3206
Email
mmcintyre@sbrc.ca
12. IPD Sharing Statement
Plan to Share IPD
No
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A Mindfulness Based Intervention as a Key Component of Successful Workplace Functioning and Personal Well-being
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