Emotional StressNCT03969771
A Mindfulness Based Intervention as a Key Component of Successful Workplace Functioning and Personal Well-being
A study testing Mindfulness-Based Stress Reduction (MBSR) in people with Emotional Stress and Work Related Illnesses, run by University of Manitoba at 1 site in Canada.
Trial 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. Read more about this study
- Who is it for?
- Any ageHealthy volunteers can take part
- Conditions the study is for
- Emotional Stress, Work Related Illnesses, Burnout, Professional
- What is being tested?
- Mindfulness-Based Stress Reduction (MBSR)
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 120 participants
- Where
- 1 siteCanada
- Study dates
- 24 Jun 2019to 1 Sep 2021
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Who may be able to join
- An employee of Actionmarguerite or St. Amant Centre in Winnipeg, Manitoba, Canada who has contact with patients.
Who cannot join
- None.
Trial locations and contacts
1 site in 1 country.
Canada1 site, 1 recruiting
- Recruiting
St. Boniface Hospital Research Centre
Winnipeg, Manitoba, R2H 2A6
Michael McIntyre, Ph.D., 1-204-235-3206, mmcintyre@sbrc.ca
About this study
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.
Read the 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.
- Being tested
- Mindfulness-Based Stress Reduction (MBSR)
- Keywords
- Mindfulness-Based Stress Reduction, Mindfulness
- Medical subject headings
- Stress, Psychological, Burnout, Professional, Burnout, Psychological
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Mindfulness-Based Stress Reduction (MBSR)Behavioural
The MBSR program was developed by the University of Massachusetts Medical School.
| Study group | Role | What they receive |
|---|---|---|
| Frequently Absent | Experimental | 8 weeks of training in Mindfulness-Based Stress Reduction Receives: Behavioral: Mindfulness-Based Stress Reduction (MBSR) |
| Normal Attendees (Controls) | Active comparator | 8 weeks of training in Mindfulness-Based Stress Reduction Receives: Behavioral: Mindfulness-Based Stress Reduction (MBSR) |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Baseline and 2 years
Secondary outcomes (11)
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.
Measured: Baseline and 2 years
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.
Measured: Baseline and 2 years
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.
Measured: Baseline and 8 weeks
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.
Measured: Baseline and 8 weeks
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.
Measured: Baseline and 8 weeks
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.
Measured: Baseline and 8 weeks
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.
Measured: Baseline and 8 weeks
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.
Measured: Baseline and 8 weeks
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.
Measured: Baseline and 8 weeks
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.
Measured: Baseline and 8 weeks
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.
Measured: Baseline and 8 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 May 2019
- Study start24 Jun 2019
- Primary completion1 Sep 2021 (estimated)
- Study completion1 Sep 2021 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Emotional StressStudies of the same condition, open and under way.
- More trials run by University of ManitobaThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- 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)
- Enrolment
- 120 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Manitoba
- Sponsor type
- University, hospital or other
- Collaborators
- Workers Compensation Board of Manitoba, Catholic Health Corporation of Manitoba
- Responsible party
- Principal investigator, Michael McIntyre, University of Manitoba
- Investigators
- Michael McIntyre, Ph.D., Principal investigator, St. Boniface Hospital Research Centre
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03969771
- Sponsor's protocol ID
- H2018:467
- Status last verified
- Jun 2019
- First submitted
- 24 May 2019
- Last updated
- 25 Jun 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 25 Jun 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Mindfulness Based Intervention as a Key Component of Successful Workplace Functioning and Personal Well-being
- ClinicalTrials.gov ID
- NCT03969771
- Acronym / sponsor ID
- H2018:467
- Keywords
- Mindfulness-Based Stress Reduction, Mindfulness
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 120 participants (estimated)
- Lead sponsor
- University of ManitobaUniversity, hospital or other
- Collaborators
- Workers Compensation Board of Manitoba, Catholic Health Corporation of Manitoba
- Study start
- 24 Jun 2019 (actual)
- Primary completion
- 1 Sep 2021 (estimated)
- Study completion
- 1 Sep 2021 (estimated)
- First posted
- 31 May 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- 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.
| Arm | Type | Receives |
|---|---|---|
| Frequently Absent | Experimental | Behavioral: Mindfulness-Based Stress Reduction (MBSR)8 weeks of training in Mindfulness-Based Stress Reduction |
| Normal Attendees (Controls) | Active comparator | Behavioral: Mindfulness-Based Stress Reduction (MBSR)8 weeks of training in Mindfulness-Based Stress Reduction |
Who may qualify
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (1 listed)
- An employee of Actionmarguerite or St. Amant Centre in Winnipeg, Manitoba, Canada who has contact with patients.
Key exclusion criteria (1 listed)
- None.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Mindfulness-Based Stress Reduction (MBSR)The MBSR program was developed by the University of Massachusetts Medical School. | Behavioural | Frequently Absent, Normal Attendees (Controls) |
Primary outcome
Change in the Number of Work Absences
Time frame: Baseline and 2 years
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.
11 secondary outcomes
Change in the Number of Workplace Accidents and Injuries
Time frame: Baseline and 2 years
Change in the Number of Late Work Arrivals
Time frame: Baseline and 2 years
Change in Perceived Stress
Time frame: Baseline and 8 weeks
Change in Burnout
Time frame: Baseline and 8 weeks
Change in Positive and Negative Emotions
Time frame: Baseline and 8 weeks
Change in Anxiety
Time frame: Baseline and 8 weeks
Change in Health Locus of Control
Time frame: Baseline and 8 weeks
Change in Workplace Deviance
Time frame: Baseline and 8 weeks
Change in Mindfulness
Time frame: Baseline and 8 weeks
Change in Self-Compassion
Time frame: Baseline and 8 weeks
Change in Fears of Compassion
Time frame: Baseline and 8 weeks
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Jun 2019.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Michael McIntyre, Ph.D. principal investigator
St. Boniface Hospital Research Centre
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Mindfulness-Based Stress Reduction (MBSR) in people with Emotional Stress and Work Related Illnesses, run by University of Manitoba at 1 site in Canada.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 25 Jun 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Michael McIntyre, Ph.D. (1-204-235-3206, mmcintyre@sbrc.ca), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in the Number of Work Absences (time frame: Baseline and 2 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 25 Jun 2019.