Clinical trial NCT02736045: Ameliorating Work Burnout and Medical Residents
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
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: NA
Conditions: Burnout, Professional
Depression
Stress
Anxiety
Distress
Lead sponsor: Larkin Community Hospital
Sponsor class: OTHER
First posted: 2016-04-13
Enrollment: 0
Sex: ALL
Minimum age (years): 25
Maximum age (years): 50
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: OTHER

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.

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).

Eligibility 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:

Primary outcomes:
measure: 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)
timeFrame: Change from baseline work burnout symptoms after 8 weeks
Secondary outcomes:
measure: Change in Depression ( measured by Epidemiologic Studies Depression Scale) (Of note, changes in Depressive Symptoms by Medical Residents will be attempted to be observed)
timeFrame: Change from baseline depressive-like symptoms after 8 weeks
Other outcomes:
measure: 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)
timeFrame: Change from baseline anxiety state after 8 weeks
measure: 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)
timeFrame: Change from baseline sleep quality index after 8 weeks
Locations:
city: South Miami
country: United States
facility: Larkin Community Hospital
state: Florida
Study officials:
affiliation: Larkin Community Hospital
name: John S Samaan, MD MPH
role: PRINCIPAL_INVESTIGATOR
affiliation: Larkin Community Hospital
name: Marcos Sanchez-Gonzalez, MD PhD
role: STUDY_CHAIR
affiliation: Larkin Community Hospital
name: Juan D Oms, MD
role: STUDY_DIRECTOR
References:
citation: Santor DA, Coyne JC. Shortening the CES-D to improve its ability to detect cases of depression 9(3) : 233-243, 1997.
citation: Maslach C, Jackson S. The measurement of experienced burnout. Journal of Organizational Behavior 2(2) 99-113, 1981.
citation: 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.
citation: Spielberger, CD. State-Trait Anxiety Inventory. Corsini Encyclopedia of Psychology 1, 2010.
citation: 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.
citation: 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.
citation: 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.