Ameliorating Work Burnout and Medical Residents

NCT ID: NCT02736045

Last Updated: 2023-10-16

Basic Information

• Recruitment Status: WITHDRAWN
• Clinical Phase: NA
• Study Classification: INTERVENTIONAL
• Study Start Date: 2015-07-01
• Study Completion Date: 2016-07-30

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).

Conditions

Burnout, Professional; Depression; Stress; Anxiety; Distress

Study Design

• Allocation Method: NON_RANDOMIZED
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: OTHER
• Blinding Strategy: SINGLE

Study Groups

Control

Sham control. Subjects will be asked to write a journal (per week).

Group Type: NO_INTERVENTION

No interventions assigned to this group

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.

Group Type: EXPERIMENTAL

emWave

Intervention Type: DEVICE

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).

Interventions

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).

Intervention Type: DEVICE

Other Intervention Names

INT

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

• Minimum Eligible Age: 25 Years
• Maximum Eligible Age: 50 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Larkin Community Hospital

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

John S Samaan, MD MPH

Role: PRINCIPAL_INVESTIGATOR

Larkin Community Hospital

Marcos Sanchez-Gonzalez, MD PhD

Role: STUDY_CHAIR

Larkin Community Hospital

Juan D Oms, MD

Role: STUDY_DIRECTOR

Larkin Community Hospital

Locations

Larkin Community Hospital

South Miami, Florida, United States

Countries

United States

References

Santor DA, Coyne JC. Shortening the CES-D to improve its ability to detect cases of depression 9(3) : 233-243, 1997.

Reference Type: BACKGROUND

Maslach C, Jackson S. The measurement of experienced burnout. Journal of Organizational Behavior 2(2) 99-113, 1981.

Reference Type: BACKGROUND

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.

Reference Type: BACKGROUND

Spielberger, CD. State-Trait Anxiety Inventory. Corsini Encyclopedia of Psychology 1, 2010.

Reference Type: BACKGROUND

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.

Reference Type: BACKGROUND

PMID: 17474998 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 11874308 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 1731137 (View on PubMed)

Other Identifiers

LCH-1-032015

Identifier Type: -

Identifier Source: org_study_id