- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02736045
Ameliorating Work Burnout and Medical Residents
The Impact of Work Burnout on Sleep Quality and Negative Emotions in Medical Residents: An Intervention for Improving Wellbeing in Graduate Medical Education
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
Background: Burnout during residency years, in particular training to obtain a medical specialty, has been well recognized. Often, burnout has been associated with poor sleep quality and negative affectivity, such as depression. However, aspects of positive emotion that have been linked to improved physical and mental health, such as trait forgiveness (TF), have been poorly explored.
For instance, according to statistics, depression in residents is as high as twenty-five percent, while residents' suffering from depression with resident burnout (defined as an occupational related syndrome of emotional exhaustion and low sense of professional accomplishment) is as high as seventy-six percent. In fact, first-year residents, with a sense of high well-being, experience great level of burnout and depression by the end of their first year. ( www.aafp.org, Yi M.S. et al. , 2007 ; Shanafelt T.D. et al. ,2002 ; Richman J.A. et. al. , 1992)
There are two specific aims my collaborators and I are focusing on in in this two-phase study:
Specific Aim 1: To explore the impact of work burnout on cognitive performance and psychological functioning in medical residents. Mounting evidence points towards the conclusion that work burnout can have a negative effect on psychological functioning in medical residents. We will test the working hypothesis that work burnout will be associated with poor cognitive performance, poor sleep quality, and high negative affectivity. Our approach is to use self-reported cognitive impairment and cognitive performance tasks designed to measure three basic processes underlying executive control: (i) updating, (ii) inhibition, and (iii) switching. Negative affective symptoms will be measured using validated psychometric scales for depression (Beck Depressive Inventory; BDI), anxiety (State-Trait Anxiety Inventory; STAI), and anger (State-Trait Anger Expression Inventory-2; STAEI-2). Sleep quality will be assessed via the Pittsburgh Sleep Quality Index (PSQI).
Specific Aim 2 - To examine the impact of an 8-week computer based resilience training intervention on work burnout, cognitive performance, and affectivity in medical residents. Our approach will be to test the impact of this intervention through a SmartPhone (e.g Android Phone or Iphone) application, emWave software, which will be provided to all our subjects. emWave is a tool that reduces stress by allowing individuals to be less reactive, think clearly, and make good decisions, especially under pressure. Fifty medical residents with high burnout symptoms will be randomized to receive an 8-week intervention (INT; n=25) or sham control (CON; n=25).
Study Type
Phase
- Not Applicable
Contacts and Locations
Study Locations
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Florida
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South Miami, Florida, United States, 33143
- Larkin Community Hospital
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Description
Inclusion Criteria:
- Must be a medical resident attending a valid residency program from either Family Medicine, Internal Medicine, Surgery or Psychiatry at Larkin Community Hospital
Exclusion Criteria:
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Other
- Allocation: Non-Randomized
- Interventional Model: Single Group Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
No Intervention: Control
Sham control.
Subjects will be asked to write a journal (per week).
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Experimental: emWave
Our approach will be to test the impact of a behavioral intervention through a smartphone application, emWave software, which will be provided to all our subjects.
The intervention (emWave) is a tool that reduces stress by allowing individuals to be less reactive, think clearly, and make good decisions, especially under pressure.
Fifty medical residents with high burnout symptoms will be randomized to receive an 8-week intervention.
|
Our approach will be to test the impact of this intervention through a smartphone application, emWave software, which will be provided to all our subjects.
emWave is a tool that reduces stress by allowing individuals to be less reactive, think clearly, and make good decisions, especially under pressure.
Fifty medical residents with high burnout symptoms will be randomized to receive an 8-week intervention (emWave - computer based resilience training program).
Other Names:
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Change in Work Burnout Symptoms ( measured by Maslach Burnout Inventory) (Of note, changes in Work Burnout Symptoms & Findings by Medical Residents will be attempted to be observed)
Time Frame: Change from baseline work burnout symptoms after 8 weeks
|
Work Burnout will be measured using the Maslach Burnout Inventory (MBI:Maslach et.
al., 1981).
The MBI consists of 22 items that are broken up into three dimensions of burnout: a) nine items relating to emotional exhaustion, b) five to depersonalization, and c) eight to personal accomplishment.
|
Change from baseline work burnout symptoms after 8 weeks
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Change in Depression ( measured by Epidemiologic Studies Depression Scale) (Of note, changes in Depressive Symptoms by Medical Residents will be attempted to be observed)
Time Frame: Change from baseline depressive-like symptoms after 8 weeks
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Depression will be measured using the 10-item Center for Epidemiologic Studies Depression Scale (CES-D; Radloff 1977, Santor and Coyne 1997).
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Change from baseline depressive-like symptoms after 8 weeks
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Other Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Change in Anxiety State ( measured by State-Trait Anxiety Inventory) ( Of note, changes in Anxiety State by Medical Residents will be attempted to be observed)
Time Frame: Change from baseline anxiety state after 8 weeks
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Anxiety will be measured using the 20-item State-Trait Anxiety Inventory (STAI; Spielberger C.D., 2010).
Satisfactory reliability (α > .7)
has been established in previous research.
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Change from baseline anxiety state after 8 weeks
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Change in Sleep Quality ( measured by Pittsburgh Sleep Quality Index) ( Of note, changes in Sleep Quality by Medical Residents will be attempted to be observed)
Time Frame: Change from baseline sleep quality index after 8 weeks
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Sleep Quality will be measured using the Pittsburgh Sleep Quality Index (PSQI).
This instrument is a well-regarded measure in the sleep research literature.
It is 19-item measure assessing sleep quality and disturbance over the past month.
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Change from baseline sleep quality index after 8 weeks
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Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: John S Samaan, MD MPH, Larkin Community Hospital
- Study Chair: Marcos Sanchez-Gonzalez, MD PhD, Larkin Community Hospital
- Study Director: Juan D Oms, MD, Larkin Community Hospital
Publications and helpful links
General Publications
- Shanafelt TD, Bradley KA, Wipf JE, Back AL. Burnout and self-reported patient care in an internal medicine residency program. Ann Intern Med. 2002 Mar 5;136(5):358-67. doi: 10.7326/0003-4819-136-5-200203050-00008.
- Santor DA, Coyne JC. Shortening the CES-D to improve its ability to detect cases of depression 9(3) : 233-243, 1997.
- Maslach C, Jackson S. The measurement of experienced burnout. Journal of Organizational Behavior 2(2) 99-113, 1981.
- Radloff L. The CES-D Scale : A Self-Report Depression Scale for Research in the General Population. Applied Psychological Measurement. 1(3) : 385-401, 1977.
- Spielberger, CD. State-Trait Anxiety Inventory. Corsini Encyclopedia of Psychology 1, 2010.
- Yi MS, Mrus JM, Mueller CV, Luckhaupt SE, Peterman AH, Puchalski CM, Tsevat J. Self-rated health of primary care house officers and its relationship to psychological and spiritual well-being. BMC Med Educ. 2007 May 2;7:9. doi: 10.1186/1472-6920-7-9.
- Richman JA, Flaherty JA, Rospenda KM, Christensen ML. Mental health consequences and correlates of reported medical student abuse. JAMA. 1992 Feb 5;267(5):692-4.
Study record dates
Study Major Dates
Study Start (Estimated)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimated)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- LCH-1-032015
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
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