University of California San Francisco

Enhanced Stress Resilience Training for Residents

Basic Trial Information

Phase: N/A
Type: Interventional    
Age: 18 - 64 Years    
Sponsor: University of California, San Francisco
Protocol IDs: 18-24601
NCT03518359    
Status: Enrolling Patients

Study Design

Principal Investigator

Lebares Carter 34267 3

Carter Lebares, M.D.
Associate Professor of Surgery
Division of General Surgery
Director, UCSF Center for Mindfulness in Surgery

Clinical Research Coordinator

Ekaterina Guvva

Ekaterina Guvva, BS
UCSF Medical Center at Parnassus
(415) 476-0973 Phone
[email protected]

Official Title: Enhanced Resilience Training to Improve Mental Health, Stress and Performance in Resident Physicians

Trial Summary

Burnout and overwhelming stress are growing issues in medicine and are associated with mental illness, performance deficits and diminished patient care. Among surgical trainees, high dispositional mindfulness decreases these risks by 75% or more, and formal mindfulness training has been shown feasible and acceptable. In other high-stress populations formal mindfulness training has improved well-being, stress, cognition and performance, yet the ability of such training to mitigate stress and burnout across medical specialties, or to affect improvements in the cognition and performance of physicians, remains unknown. To address these gaps and thereby promote the wider adoption of contemplative practices within medical training, investigators have developed Enhanced Stress Resilience Training, a modified form of MBSR - streamlined, tailored and contextualized for physicians and trainees. Investigators propose to test Enhanced Stress Resilience Training (ESRT), versus active control and residency-as-usual, in mixed-specialty interns (from Emergency Medicine, Internal Medicine, Pediatrics, Family Practice, OBGYN and Surgery Departments) evaluated for well-being, cognition and performance changes at baseline, post-intervention and three or six-month follow-up.

Eligibility

Inclusion Criteria:
Any consented medical intern from Emergency Medecine, Internal Medicine, Pediatrics,Family Practice, OBGYN and Surgery Departments in-coming to University of CaliforniaSan Francisco in the study year.

Exclusion Criteria:

  • Current personal mindfulness practice;
  • Use of medications with Central Nervous System effects;
  • Lifetime history of an organic mental illness;
  • Acute or chronic immune or inflammatory disorders;
  • Pregnancy;
  • Breast-feeding;
  • Implanted MRI-incompatible metal.

Detailed Description

Experiencing joy in the practice of medicine is by no means guaranteed. For many physicians,the unique bond with patients, the deep satisfaction of saving a life, and a profound senseof calling make the sacrifice and heartache worthwhile. In contrast, the growing prevalenceof burnout and mental distress in physicians is being linked to diminished performance,patient outcomes, and hospital economics. This has broad ramifications, including threateningthe physician-patient bond and the societal pillar this represents.Overwhelming stress without adequate coping skills has been posited to promote burnout anddistress, and may promote performance deficits (from surgical errors to poor professionalism)by impairing cognition and self-regulation. In other high-stress/high-performance groupsformal mindfulness training has been shown to enhance stress resilience, well-being andperformance. Nevertheless, quality research exploring the effects of mindfulness training onchronic stress and performance in physicians remains scarce, contributing to the slowadoption of mindfulness training into medical practice and residency.To date, investigators have conducted a national survey which showed that the presence ofhigh dispositional mindfulness in surgery residents reduced the risk of burnout and distressby 75% or more. Investigators have conducted a Randomized Clinical Trial of Mindfulness-BasedStress Reduction (MBSR) in surgery interns, demonstrating feasibility and acceptability offormal mindfulness training as well as promising positive effects in well-being, cognitionand performance. Finally, investigators developed an MBSR-based, streamlined curriculumtailored for physicians called Enhanced Stress Resilience Training (ESRT). ESRT has beenbeta-tested in surgery and anesthesia faculty and mixed-level residents allowing refinementin terms of logistics, dose and delivery. Investigators have disseminated promising results,thereby generating access to a larger study population for the proposed Randomized ClinicalTrial in mixed-specialty interns, studying ESRT as a means to improve well-being, cognitionand performance.As such, the investigators aim to:Aim 1. Assess the feasibility of ESRT for multi-specialty interns. Aim 2. Optimize andManualize ESRT. Aim 3. Identify outcome measures that are feasible and reflect relevantintervention targets for physicians' well-being, cognition and performance.While this study will likely not reach statistical power, it will absolutely allow forbroader vetting of the curriculum, testing of scaled-up data acquisition and managementmethods, and the appropriateness of the outcome measures in a mixed-specialty population,paving the way for a high-quality, fully-powered multi-center trial in the near future.The significance of studying mindfulness mental training in medical and surgical trainees istwo-fold.One, as a process-centered skill with demonstrated effects on psychological well-being,perceived stress, cognitive performance and physiologic health, mindfulness represents apotential gateway mechanism for providing individuals with a 'universal tool' to addresschallenges across all stages of medical training and practice. This includes burnout anderrors, both looming issues that have been largely immutable for the last decade.Two, if feasibility and efficacy among medical and surgical trainees can be shown, the socialclout of impacting such a high stress and high performance field is uniquely powerful andcould further the dissemination of evidence-based mindfulness interventions to a remarkabledegree. Finally, the enhanced self-awareness and equipoise frequently resulting frommindfulness training has been contagious in other settings, and could hold great promise fora culture change in medicine that benefits patients and providers, alike.The innovation of this work is in bringing a mind-body intervention to bear not only onwell-being but also on the fundamental cognitive processes believed to sub-serve performance,such as the impact of attention and working memory capacity on medical decision-making, andthe impact of emotional regulation and self-awareness on professionalism and team work. Thepotential to improve both the operative and clinical environments as well as medical errorsis unprecedented. Finally, a vetted, manualized curriculum specifically crafted forphysicians could accelerate dissemination nationally.

Important

Final eligibility is determined by the health professionals conducting the trial and the protocol approved by the Committee on Human Resources (CHR) at the University of California, San Francisco (UCSF). The Patient Consent Form for this trial is available upon request. For more information about this trial, please see the full posting at ClinicalTrials.gov.

Information about this trial was obtained from the NIH Clinical Trials website, http://clinicaltrials.gov on 5/21/2018. UCSF specific information including the PI (Principal Investigator), trial enrollment status, and UCSF Study ID, supplement the ClinicalTrials.gov study posting.