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Ameliorating Work Burnout and Medical Residents

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ClinicalTrials.gov Identifier: NCT02736045
Recruitment Status : Withdrawn (No participants enrolled)
First Posted : April 13, 2016
Last Update Posted : August 30, 2019
Sponsor:
Information provided by (Responsible Party):
Larkin Community Hospital

Brief Summary:
Prior research has demonstrated that during residency years, in particular training to obtain a medical specialty, work burnout is a very prevalent problem. Work burnout is defined as a syndrome of dysfunction in three domains, emotional exhaustion, depersonalization, and a reduced sense of personal accomplishment. (Maslach et. al., 1981). Often, burnout has been associated with poor sleep quality and negative affectivity, such as depression and anxiety. In fact, our preliminary data demonstrate that burnout in medical residents affects sleep quality, and increases negative emotions. Strikingly, burnout in medical residents negatively impacts working performance as well as patient-physician interactions, and hence may affect the quality of health care. However, lacking are studies aimed at understating how work burnout affects cognitive performance and decision making in medical residents. The proposed study will provide essential groundwork in demonstrating the link between burnout and impaired cognitive performance. In addition, the proposed study will demonstrate feasibility for a future trial to test whether an intervention, emWave, integrating a computer based stress management (resilience training), can have a positive impact on residents with high burnout symptoms. The amelioration of psychological risk factors in medical residents may lead to improved physician-patient relationships in the service of improved quality of care.

Condition or disease Intervention/treatment Phase
Burnout, Professional Depression Stress Anxiety Distress Device: emWave Not Applicable

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).


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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 0 participants
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: Single (Participant)
Primary Purpose: Other
Official Title: The Impact of Work Burnout on Sleep Quality and Negative Emotions in Medical Residents: An Intervention for Improving Wellbeing in Graduate Medical Education
Estimated Study Start Date : July 1, 2015
Actual Primary Completion Date : July 30, 2016
Actual Study Completion Date : July 30, 2016

Arm Intervention/treatment
No Intervention: Control
Sham control. Subjects will be asked to write a journal (per week).
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.
Device: emWave
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 Name: INT




Primary Outcome Measures :
  1. 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.


Secondary Outcome Measures :
  1. 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 ]
    Depression will be measured using the 10-item Center for Epidemiologic Studies Depression Scale (CES-D; Radloff 1977, Santor and Coyne 1997).


Other Outcome Measures:
  1. 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 ]
    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.

  2. 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 ]
    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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Ages Eligible for Study:   25 Years to 50 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

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:


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): NCT02736045


Locations
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United States, Florida
Larkin Community Hospital
South Miami, Florida, United States, 33143
Sponsors and Collaborators
Larkin Community Hospital
Investigators
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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:
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.

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Responsible Party: Larkin Community Hospital
ClinicalTrials.gov Identifier: NCT02736045     History of Changes
Other Study ID Numbers: LCH-1-032015
First Posted: April 13, 2016    Key Record Dates
Last Update Posted: August 30, 2019
Last Verified: August 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided
Additional relevant MeSH terms:
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Burnout, Professional
Burnout, Psychological
Behavioral Symptoms
Stress, Psychological
Occupational Stress
Occupational Diseases