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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.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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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
What is being tested?
Mindfulness-Based Stress Reduction (MBSR)
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.

Michael McIntyre, Ph.D. contact

1-204-235-3206

mmcintyre@sbrc.ca

Canada1 site, 1 recruiting
  • St. Boniface Hospital Research Centre

    Winnipeg, Manitoba, R2H 2A6

    Michael McIntyre, Ph.D., 1-204-235-3206, mmcintyre@sbrc.ca

    Recruiting

Other trials in Canada

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 groups in NCT03969771
Study groupRoleWhat they receive
Frequently AbsentExperimental8 weeks of training in Mindfulness-Based Stress Reduction
Receives: Behavioral: Mindfulness-Based Stress Reduction (MBSR)
Normal Attendees (Controls)Active comparator8 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.

  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.

    Measured: Baseline and 2 years

Secondary outcomes (11)
  1. 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

  2. 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

  3. 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

  4. 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

  5. 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

  6. 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

  7. 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

  8. 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

  9. 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

  10. 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

  11. 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.

  1. First posted31 May 2019
  2. Study start24 Jun 2019
  3. Primary completion1 Sep 2021 (estimated)
  4. Study completion1 Sep 2021 (estimated)

Resources

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)
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

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.

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