- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03514862
Mindfulness Training for Medical Personnel
February 11, 2019 updated by: David Lee, PhD, University of Miami
Mindfulness Resiliency Training Pilot for University of Miami Medical Personnel
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.
Study Overview
Status
Completed
Conditions
Study Type
Interventional
Enrollment (Actual)
74
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
Florida
-
Miami, Florida, United States, 33136
- University of Miami Miller School of Medicine
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
- Child
- Adult
- Older Adult
Accepts Healthy Volunteers
Yes
Genders Eligible for Study
All
Description
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.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: Intervention
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.
|
Four additional mindfulness booster sessions after the 4-week MBI program.
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.
|
|
Active Comparator: Control
Participants will participate in 4 weeks of the Mindfulness-Based Intervention (MBI) and then continue to Self-Practice for 4 weeks.
|
Four additional mindfulness booster sessions after the 4-week MBI program.
4 weeks of self-practice after the MBI training.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Change in measure of stress
Time Frame: Baseline, 4-weeks, 3-months, 6-months
|
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.
|
Baseline, 4-weeks, 3-months, 6-months
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Change in measure of burnout
Time Frame: Baseline, 4-weeks, 3-months, 6-months
|
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.
|
Baseline, 4-weeks, 3-months, 6-months
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Principal Investigator: David J Lee, PhD, University of Miami
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
March 29, 2018
Primary Completion (Actual)
November 27, 2018
Study Completion (Actual)
November 27, 2018
Study Registration Dates
First Submitted
April 20, 2018
First Submitted That Met QC Criteria
April 20, 2018
First Posted (Actual)
May 2, 2018
Study Record Updates
Last Update Posted (Actual)
February 12, 2019
Last Update Submitted That Met QC Criteria
February 11, 2019
Last Verified
February 1, 2019
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 20180138
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
NO
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.