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Mindful Mental Training for Surgeons to Enhance Resilience and Performance Under Stress

Official Title:

Mindfulness Training to Improve Mental Health, Stress and Performance In Physicians

Basic Trial Information

Phase Type Age Sponsor Protocol IDs Status
N/A Interventional 18 Years and older University of California, San Francisco 16-19688
NCT03141190
Enrolling by invitation

Study Design:


Principal Investigator

Assistant Professor of Surgery
Division of General Surgery


Trial Summary

Our understanding of the magnitude of physician burnout, its relationship to diminished performance and the development of mental and physical illness is crystalizing. Data now links burnout with diminished physician professionalism, patient outcomes, hospital economics and patient safety.

Moreover, burnout appears to be a surrogate measure of distress among physicians. In a national survey of practicing surgeons, alcohol misuse and suicidal ideation were up to 3 times that of the general population. When burnout was present the likelihood increased 25% and 90%, respectively. Among physicians in general, burnout increases the likelihood of depressive symptoms 170%. In surgical trainees, there is alarming prevalence of distress symptoms, with a recent national survey (manuscript in preparation) showing 16% suicidal ideation, 32% moderate to severe depression, 58% high stress and 61% alcohol misuse or abuse among PGY-3s. It has been proposed that chronic and overwhelming stress in the absence of adequate coping skills promotes burnout and associated distress symptoms. It has also been posited that performance deficits, from surgical errors to poor professionalism, derive in large part from the deleterious effects of stress on cognition.

Mindfulness mental training, most frequently in the form of Mindfulness-Based Stress Reduction (MBSR, as developed by John Kabat-Zinn), has been shown to protect or enhance cognition, well-being and physical health in multiple clinical populations and in healthy adults. Two decades of research have shown that MBSR and MBSR-based interventions create new habits in the brain subserved by organic, structural changes. Such interventions have been shown to protect cognitive function in pre-deployment marines and incarcerated juveniles; reduce relapse in major depressive disorder; enhance immune function in HIV+ males; reduce PTSD severity in veterans; enhance job performance in inner-city teachers; improve cognitive function and pro-social skills in children; increase professionalism and decrease burnout in PCPs; improve work satisfaction and engagement in numerous populations of health care workers; and diminish psychological stress in soldiers, physicians and professional athletes.

This study seeks to demonstrate the feasibility of mindfulness training in surgical Interns while simultaneously providing objective pilot data on the effectiveness of mindfulness training in a randomized, controlled setting. In-coming surgical Interns will be recruited, randomized to mindfulness training or an active control group and undergo psychologic, physiologic, neurocognitive, neuroanatomic and performance assessments at baseline, post-intervention and one year later. Data will inform sample size calculations for subsequent, adequately-powered RCTs and will guide the creation of a feasible formal training model. Moreover, results could significantly impact formal medical training, the mental health of providers at every level, and the overall quality of patient care.

Eligibility

Inclusion Criteria:
  • UCSF surgical interns entering training. Do not meet exclusion criteria.
Exclusion Criteria:
  • Current personal mindfulness practice, medications with CNS effects, lifetime history
    of a mental disorder, acute or chronic immune or inflammatory disorders, pregnancy,
    breast-feeding or implanted MRI-incompatible metal.

Detailed Description

Burnout, which comprises emotional exhaustion, depersonalization and diminished satisfaction
with one's work, has been documented among front-line physicians since 1981. Since then,
burnout has been reported in medical students, trainees and every medical specialty
examined, including 69% of surgical residents and 40-60% of practicing physicians. The
problem is growing: a recent national survey of US physicians showed an 8.9% increase in
burnout between 2011 and 2014.
Concomitantly, our understanding of the relationship between physician burnout, diminished
performance and the development of mental and physical illness is crystalizing. Data now
links burnout with diminished physician professionalism, patient outcomes, hospital
economics and patient safety. Moreover, burnout appears to be a surrogate measure of
distress and vulnerability among physicians. In practicing surgeons, alcohol misuse and
suicidal ideation are up to 3 times that of the general population, but when burnout exists
the likelihood increases 25% and 90%, respectively. Among physicians in general, when
burnout is present, depressive symptoms are 170% more likely. In surgical trainees, there is
alarming prevalence of distress symptoms, with a recent national survey (manuscript in
preparation) showing 16% suicidal ideation, 32% moderate to severe depression, 58% high
stress and 61% alcohol misuse or abuse among PGY-3s.
It has been proposed that chronic and overwhelming stress, in the absence of adequate coping
skills, promotes burnout and associated distress symptoms. It has also been posited that
performance deficits, from surgical errors to poor professionalism, derive from stress
effects on cognition. Very few studies have examined the effects of burnout on performance
among surgeons and surgical trainees, nor have any focused on mediating psychological
characteristics in this population. Moreover, while recent studies have described
environmental assets that may reduce the risk of burnout and distress, there is very little
work testing individual-based interventions among surgeons and no work to date focusing on
mindfulness in this population. Interestingly, our cross-sectional national survey of
general surgery residents examined psychological characteristics that mediate stress and
found that dispositional mindfulness reduces the risk of burnout, perceived stress, alcohol
misuse and abuse, moderate to severe depression and suicidal ideation.
In this context, we suggest that purposeful mindfulness training could be a powerful
component of stress resilience training among surgeons and surgical trainees. This
hypothesis is further supported by the Mindful Surgeon pilot RCT of surgical interns who
underwent an 8-wk formalized mindfulness mental training curriculum with pre-, post- and 1
year follow-up assessment in 2016. Outcome measures included burnout, depression,
suicidality, stress, mindfulness, executive function testing, circulating biomarkers of
stress and functional MRI of the brain and neural circuitry. Data is still being collected
and analyzed, but preliminary analysis suggests that the intervention arm manifests less
stress and stress deterioration than controls.
We propose to repeat this pilot RCT with greater numbers of participants, although still
focusing on the in-coming class of surgical interns at a single institution. Recruitment
will happen through email, describing the voluntary opportunity to participate and the
details of the study commitment. For those that meet inclusion criteria, baseline
assessments will occur during 'Bootcamp Week' which is a mandatory immersion experience for
all new surgical interns at UCSF. Assessments include questionnaires to assess burnout,
stress, mental health and coping strategies, biologic markers of stress and resilience,
executive function, motor skills acquisition and fMRI brain scans. Participants will then
undergo the 8 weeks of either intervention or active-control condition and have repeated
assessment right after completion. Long-term follow-up with involve re-assessment at
6-months and 1 year.
The significance of studying mindfulness mental training in surgeons and surgical trainees
is two-fold: 1) As a process-centered skill with demonstrated effects on psychological
well-being, perceived stress, cognitive performance and physiologic health it presents a
potential gateway mechanism for providing individuals with a 'universal tool' for challenges
across all stages of medical training and practice, including burnout and errors which have
been largely immutable problems for the last decade. 2) If efficacy among surgeons 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.
The innovation of this work is in bringing a mind-body intervention (mindfulness mental
training) to bear in a meaningful way in one of the most traditionally conservative branches
of medicine. Additionally, the focus of such training on the cognitive processes that
underlie surgical expertise - as a means of improving both surgical errors and surgical
training - is unprecedented. In all, the potential for advancing an evidence-based culture
change focused on well-being and performance enhancement is remarkable.

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 7/3/2017. UCSF specific information including the PI (Principal Investigator), trial enrollment status, and UCSF Study ID, supplement the ClinicalTrials.gov study posting.
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