Back to resultsMindfulness Training for Medical Personnel
Primary Purpose
Burnout, Professional, Stress
Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Mindfulness Booster Training
Mindfulness-Based Intervention (MBI)
Self-Practice
Sponsored by
About this trial
This is an interventional treatment trial for Burnout, Professional
Eligibility Criteria
Inclusion Criteria:
- Medical faculty, fellows, residents, and other allied healthcare providers at UM Miller School of Medicine and Jackson will be eligible for participation in the study.
Exclusion Criteria:
- Those not falling into inclusion criteria.
Sites / Locations
- University of Miami Miller School of Medicine
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
Intervention
Control
Arm Description
Participants will participate in 4 weeks of the Mindfulness-Based Intervention (MBI) and then will be invited to continue to participate in 4 additional Mindfulness Booster Training.
Participants will participate in 4 weeks of the Mindfulness-Based Intervention (MBI) and then continue to Self-Practice for 4 weeks.
Outcomes
Primary Outcome Measures
Change in measure of stress
Stress will be measured using the Perceived Stress Scale, a short-form 4 item scale with a range of 0 to 16, with higher scores representing greater stress. Baseline responses will be compared to 4-week assessment responses of the control and intervention groups. Results between the control and intervention groups will be compared for statistical significance.
Secondary Outcome Measures
Change in measure of burnout
Burnout is measured using the 19-item Copenhagen Burnout Inventory including subscales assessing personal burnout, work-related burnout and patient-related burnout. Scores range from 0 to 100. Total score on the scale is the average of the scores on the items with a higher mean representing greater burnout. Baseline responses will be compared to 4-week assessment responses of the control and intervention groups. Results between the control and intervention groups will be compared for statistical significance.
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT03514862
Brief Title
Mindfulness Training for Medical Personnel
Official Title
Mindfulness Resiliency Training Pilot for University of Miami Medical Personnel
Study Type
Interventional
2. Study Status
Record Verification Date
February 2019
Overall Recruitment Status
Completed
Study Start Date
March 29, 2018 (Actual)
Primary Completion Date
November 27, 2018 (Actual)
Study Completion Date
November 27, 2018 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Miami
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
In this project, the investigators propose to evaluate the impact of a Mindfulness-Based Intervention (MBI) Program on the well-being of University of Miami (UM) clinicians and faculty/staff. If successfully implemented and proven to be effective, this training program may be disseminated to other interested medical personnel.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Burnout, Professional, Stress
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
74 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Intervention
Arm Type
Experimental
Arm Description
Participants will participate in 4 weeks of the Mindfulness-Based Intervention (MBI) and then will be invited to continue to participate in 4 additional Mindfulness Booster Training.
Arm Title
Control
Arm Type
Active Comparator
Arm Description
Participants will participate in 4 weeks of the Mindfulness-Based Intervention (MBI) and then continue to Self-Practice for 4 weeks.
Intervention Type
Behavioral
Intervention Name(s)
Mindfulness Booster Training
Intervention Description
Four additional mindfulness booster sessions after the 4-week MBI program.
Intervention Type
Behavioral
Intervention Name(s)
Mindfulness-Based Intervention (MBI)
Intervention Description
MBI program is delivered once a week for 4 weeks, 90 minutes each preceded by a 90-minute orientation session. The training sessions will include discussion, and introduction and practice of mindfulness practices.
Intervention Type
Behavioral
Intervention Name(s)
Self-Practice
Intervention Description
4 weeks of self-practice after the MBI training.
Primary Outcome Measure Information:
Title
Change in measure of stress
Description
Stress will be measured using the Perceived Stress Scale, a short-form 4 item scale with a range of 0 to 16, with higher scores representing greater stress. Baseline responses will be compared to 4-week assessment responses of the control and intervention groups. Results between the control and intervention groups will be compared for statistical significance.
Time Frame
Baseline, 4-weeks, 3-months, 6-months
Secondary Outcome Measure Information:
Title
Change in measure of burnout
Description
Burnout is measured using the 19-item Copenhagen Burnout Inventory including subscales assessing personal burnout, work-related burnout and patient-related burnout. Scores range from 0 to 100. Total score on the scale is the average of the scores on the items with a higher mean representing greater burnout. Baseline responses will be compared to 4-week assessment responses of the control and intervention groups. Results between the control and intervention groups will be compared for statistical significance.
Time Frame
Baseline, 4-weeks, 3-months, 6-months
10. Eligibility
Sex
All
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria:
Medical faculty, fellows, residents, and other allied healthcare providers at UM Miller School of Medicine and Jackson will be eligible for participation in the study.
Exclusion Criteria:
Those not falling into inclusion criteria.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
David J Lee, PhD
Organizational Affiliation
University of Miami
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of Miami Miller School of Medicine
City
Miami
State/Province
Florida
ZIP/Postal Code
33136
Country
United States
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
Mindfulness Training for Medical Personnel
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