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COVID-19 Burnout Study

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04594278
Recruitment Status : Not yet recruiting
First Posted : October 20, 2020
Last Update Posted : October 6, 2021
Sponsor:
Information provided by (Responsible Party):
University Health Network, Toronto

Brief Summary:
The aims of this study are to assess whether the use of a MBI therapy delivered remotely is associated with a reduction of perceived stress among HCPs in the Radiation Medicine Program (RMP) and with a decrease risk of burnout during and post COVID-19.

Condition or disease Intervention/treatment Phase
Stress Behavioral: Mindfulness Based Intervention Not Applicable

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 100 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Health Services Research
Official Title: Remote Delivery of a Mindfulness-based Intervention to Decrease Anxiety Levels and Burnout Among Health-care Professionals During the Covid-19 Pandemic
Estimated Study Start Date : November 2021
Estimated Primary Completion Date : April 2022
Estimated Study Completion Date : July 2022

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Mindfulness Based Intervention
A remotely delivered closed group mindfulness-based intervention using Microsoft Teams Meeting will be performed, consisting of 12-16 participants (Maximum 10 groups) and one professional with a background in mindfulness coaching . Three professionals will be coaching 2-3 groups each. The curriculum entails weekly sessions (1 hour) over a 4-week period.
Behavioral: Mindfulness Based Intervention
A remotely delivered closed group mindfulness-based intervention using Microsoft Teams Meeting will be performed, consisting of 12-16 participants (Maximum 10 groups) and one professional with a background in mindfulness coaching . Three professionals will be coaching 2-3 groups each. The curriculum entails weekly sessions (1 hour) over a 4-week period.




Primary Outcome Measures :
  1. Perceived Stress [ Time Frame: 6 months ]
    Perceived Stress measured by the Perceived Stress Scale/ Higher number indicates higher levels of stress. Minimum value = 10, Max Value = 40


Secondary Outcome Measures :
  1. Burnout [ Time Frame: 6 months ]
    Burnout assessed by the 2-item Maslach Burnout Inventory using single-item measures of emotional exhaustion and depersonalization

  2. Coping with Stress [ Time Frame: 6 months ]
    Coping measured by the BriefCOPE questionnaire. High numbers indicate that the participant is not coping well with the specific situation. Minimum value = 28, Max Value = 112



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • -Employee in the radiation medicine program in UHN
  • Health Care Professional (Therapist, Nurse, Physician, Resident, Physician assistant, Physician admin assistant)
  • Over 18

Exclusion Criteria:

  • Not working at the radiation medicine program at UHN
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Responsible Party: University Health Network, Toronto
ClinicalTrials.gov Identifier: NCT04594278    
Other Study ID Numbers: 20-5678
First Posted: October 20, 2020    Key Record Dates
Last Update Posted: October 6, 2021
Last Verified: October 2021

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Burnout, Psychological
Stress, Psychological
Behavioral Symptoms