Ameliorating Work Burnout and Medical Residents

Sponsor
Larkin Community Hospital (Other)
Overall Status
Withdrawn
CT.gov ID
NCT02736045
Collaborator
(none)
0
1
2
13
0

Study Details

Study Description

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
  • Device: emWave
N/A

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 Design

Study Type:
Interventional
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
Anticipated Study Start Date :
Jul 1, 2015
Actual Primary Completion Date :
Jul 30, 2016
Actual Study Completion Date :
Jul 30, 2016

Arms and Interventions

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 Names:
  • INT
  • Outcome Measures

    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) [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) [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) [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) [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.

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    25 Years to 50 Years
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    Yes
    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:

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Larkin Community Hospital South Miami Florida United States 33143

    Sponsors and Collaborators

    • Larkin Community Hospital

    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

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    Responsible Party:
    Larkin Community Hospital
    ClinicalTrials.gov Identifier:
    NCT02736045
    Other Study ID Numbers:
    • LCH-1-032015
    First Posted:
    Apr 13, 2016
    Last Update Posted:
    Aug 30, 2019
    Last Verified:
    Aug 1, 2019
    Individual Participant Data (IPD) Sharing Statement:
    Undecided
    Plan to Share IPD:
    Undecided
    Additional relevant MeSH terms:

    Study Results

    No Results Posted as of Aug 30, 2019