Enhanced Stress Resilience Training for Residents
Official Title:
Enhanced Resilience Training to Improve Mental Health, Stress and Performance in Resident PhysiciansBasic Trial Information
| Phase | Type | Age | Sponsor | Protocol IDs | Status |
|---|---|---|---|---|---|
| N/A | Interventional | 18 - 64 Years | University of California, San Francisco |
18-24601 NCT03518359 |
Enrolling patients |
Study Design:
Principal Investigator
Associate Professor of Surgery
Division of General Surgery
Director, UCSF Center for Mindfulness in Surgery
Clinical Research Coordinator
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 Depratments in-coming to University of California
San 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 sense
of calling make the sacrifice and heartache worthwhile. In contrast, the growing prevalence
of burnout and mental distress in physicians is being linked to diminished performance,
patient outcomes, and hospital economics. This has broad ramifications, including threatening
the physician-patient bond and the societal pillar this represents.
Overwhelming stress without adequate coping skills has been posited to promote burnout and
distress, and may promote performance deficits (from surgical errors to poor professionalism)
by impairing cognition and self-regulation. In other high-stress/high-performance groups
formal mindfulness training has been shown to enhance stress resilience, well-being and
performance. Nevertheless, quality research exploring the effects of mindfulness training on
chronic stress and performance in physicians remains scarce, contributing to the slow
adoption of mindfulness training into medical practice and residency.
To date, investigators have conducted a national survey which showed that the presence of
high dispositional mindfulness in surgery residents reduced the risk of burnout and distress
by 75% or more. Investigators have conducted a Randomized Clinical Trial of Mindfulness-Based
Stress Reduction (MBSR) in surgery interns, demonstrating feasibility and acceptability of
formal mindfulness training as well as promising positive effects in well-being, cognition
and performance. Finally, investigators developed an MBSR-based, streamlined curriculum
tailored for physicians called Enhanced Stress Resilience Training (ESRT). ESRT has been
beta-tested in surgery and anesthesia faculty and mixed-level residents allowing refinement
in terms of logistics, dose and delivery. Investigators have disseminated promising results,
thereby generating access to a larger study population for the proposed Randomized Clinical
Trial in mixed-specialty interns, studying ESRT as a means to improve well-being, cognition
and performance.
As such, the investigators aim to:
Aim 1. Assess the feasibility of ESRT for multi-specialty interns. Aim 2. Optimize and
Manualize ESRT. Aim 3. Identify outcome measures that are feasible and reflect relevant
intervention targets for physicians' well-being, cognition and performance.
While this study will likely not reach statistical power, it will absolutely allow for
broader vetting of the curriculum, testing of scaled-up data acquisition and management
methods, 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 is
two-fold.
One, as a process-centered skill with demonstrated effects on psychological well-being,
perceived stress, cognitive performance and physiologic health, mindfulness represents a
potential gateway mechanism for providing individuals with a 'universal tool' to address
challenges across all stages of medical training and practice. This includes burnout and
errors, 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 social
clout of impacting such a high stress and high performance field is uniquely powerful and
could further the dissemination of evidence-based mindfulness interventions to a remarkable
degree. Finally, the enhanced self-awareness and equipoise frequently resulting from
mindfulness training has been contagious in other settings, and could hold great promise for
a 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 on
well-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, and
the impact of emotional regulation and self-awareness on professionalism and team work. The
potential to improve both the operative and clinical environments as well as medical errors
is unprecedented. Finally, a vetted, manualized curriculum specifically crafted for
physicians 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.