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Mindfulness Training for Medical Personnel

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ClinicalTrials.gov Identifier: NCT03514862
Recruitment Status : Completed
First Posted : May 2, 2018
Last Update Posted : February 12, 2019
Sponsor:
Information provided by (Responsible Party):
David Lee, PhD, University of Miami

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.

Condition or disease Intervention/treatment Phase
Burnout, Professional Stress Behavioral: Mindfulness Booster Training Behavioral: Mindfulness-Based Intervention (MBI) Behavioral: Self-Practice Not Applicable

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 74 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Mindfulness Resiliency Training Pilot for University of Miami Medical Personnel
Actual Study Start Date : March 29, 2018
Actual Primary Completion Date : November 27, 2018
Actual Study Completion Date : November 27, 2018

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.
Behavioral: Mindfulness Booster Training
Four additional mindfulness booster sessions after the 4-week MBI program.

Behavioral: Mindfulness-Based Intervention (MBI)
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.
Behavioral: Mindfulness Booster Training
Four additional mindfulness booster sessions after the 4-week MBI program.

Behavioral: Self-Practice
4 weeks of self-practice after the MBI training.




Primary Outcome Measures :
  1. 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.


Secondary Outcome Measures :
  1. 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.



Information from the National Library of Medicine

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Ages Eligible for Study:   Child, Adult, Older Adult
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03514862


Locations
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United States, Florida
University of Miami Miller School of Medicine
Miami, Florida, United States, 33136
Sponsors and Collaborators
University of Miami
Investigators
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Principal Investigator: David J Lee, PhD University of Miami

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Responsible Party: David Lee, PhD, Professor, University of Miami
ClinicalTrials.gov Identifier: NCT03514862    
Other Study ID Numbers: 20180138
First Posted: May 2, 2018    Key Record Dates
Last Update Posted: February 12, 2019
Last Verified: February 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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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, Professional
Burnout, Psychological
Stress, Psychological
Behavioral Symptoms
Occupational Stress
Occupational Diseases