Ameliorating Work Burnout and Medical Residents

NCT02736045 | Withdrawn

• 1 other identifier: LCH-1-032015
• Study Type: interventional
• Target: N/A
• Locations: 1 country
• Sites: 1

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.

Conditions

Burnout, Professional; Depression; Stress; Anxiety; Distress

Outcome Measures

Primary Outcomes (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)

  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

Secondary Outcomes (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

Other Outcomes (2)

• 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

• 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

Study Arms (2)

Control

NO INTERVENTION

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

emWave

EXPERIMENTAL

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

Interventions

emWave 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).

Also known as: INT

emWave

Eligibility Criteria

• Age: 25 Years - 50 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• Must be a medical resident attending a valid residency program from either Family Medicine, Internal Medicine, Surgery or Psychiatry at Larkin Community Hospital

Sponsors & Collaborators

• Larkin Community Hospital: lead

Study Sites (1)

Larkin Community Hospital

South Miami, Florida, 33143, United States

Location

Related Publications (7)

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

  BACKGROUND

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

  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.

  BACKGROUND

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

  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.

  PMID: 17474998 BACKGROUND

• 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.

  PMID: 11874308 BACKGROUND

• 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.

  PMID: 1731137 BACKGROUND

MeSH Terms

Conditions

Burnout, Professional; Depression; Anxiety Disorders

Condition Hierarchy (Ancestors)

Occupational Stress; Occupational Diseases; Burnout, Psychological; Stress, Psychological; Behavioral Symptoms; Behavior; Mental Disorders

Study Officials

• John S Samaan, MD MPH

  Larkin Community Hospital

  PRINCIPAL INVESTIGATOR

• Marcos Sanchez-Gonzalez, MD PhD

  Larkin Community Hospital

  STUDY CHAIR

• Juan D Oms, MD

  Larkin Community Hospital

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: OTHER
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 27, 2015
• First Posted: April 13, 2016
• Study Start: July 1, 2015
• Primary Completion: July 30, 2016
• Study Completion: July 30, 2016
• Last Updated: October 16, 2023

Record last verified: 2023-10

Locations

US (1)