Study Results
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Basic Information
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COMPLETED
NA
45 participants
INTERVENTIONAL
2018-06-13
2021-06-30
Brief Summary
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Detailed Description
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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, subjective well-being and performance. Nevertheless, quality research involving physicians, the effects of chronic stress on performance and the impact of mindfulness training in this context remains scarce, contributing to the slow adoption of mindfulness training into medical practice and residency.
To address these gaps, we first laid the groundwork: we conducted a national survey which showed high dispositional mindfulness in surgery residents reduced the risk of burnout and distress by 75% or more. We conducted a RCT of MBSR in surgery interns, demonstrating feasibility and acceptability of formal mindfulness training. Finally, we have developed an MBSR-based, streamlined curriculum tailored for physicians and trainees, Enhanced Stress Resilience Training (ESRT), which has been beta-tested in surgery faculty and mixed-level residents and refined in terms of logistics, dose and delivery. We have since disseminated our promising results, thereby allowing us access to a larger study population for our proposed RCT of ESRT in mixed-specialty interns as a means to improve well-being, cognition and performance.
While this study will likely not reach statistical power, it will absolutely allow for broader vetting of the curriculum, our current data acquisition and management methods, and the appropriateness of our outcome measures, paving the way for a high-quality, fully-powered MCT 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 presents a potential gateway mechanism for providing individuals with a 'universal tool' for challenges across all stages of medical training and practice. This includes burnout and errors which are looming issues, 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 resultant tendency for enhanced self-awareness and equipoise has been contagious in other settings, providing fuel for a greater culture change in medicine that is much-needed and holds great promise for patients and providers.
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.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
PREVENTION
DOUBLE
Study Groups
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Mental Training for Residents
The intervention will be the modified form of Mindfulness-Based Stress Reduction (MBSR). For this study investigator named the experimental arm Enhanced Stress Resilience Training (ESRT).
Enhanced Stress Resilience Training (ESRT)
ESRT involves six weekly 90-minute group classes and one 2 - 4 hour retreat. Classes focus on developing mindfulness skills (i.e. sustained attention, open monitoring, emotional regulation, meta-cognition) in the context of skills and concepts for managing stress, particularly in practicing medicine. Homework consists of 20 minutes per day of mindfulness exercises following guided meditation CDs or videos of movement-based practice, and practice will be reported periodically by text. A 3-hour outdoor retreat occurs at week six. The central exercises of ESRT are the body scan, sitting meditation, chi gong and yoga. For both arms, the weekly teaching sessions occur on a workday morning during protected time at Parnassus, Mission Bay or Zuckerberg San Francisco General Hospital campus.
Active Control
Active control that emphasizes externalized attention via the "shared reading and listening" model.
Active Control
Control group participants will meet for 6 weeks, 90 minutes each week, for classes focuses on stress management through rest and exercise, with equivalent protected time and small group bonding but without the use of contemplative practices. Topics will include the history of surgery, patient perspective, the physician personality, technical mastery, fallibility and limits, balancing compassion and detachment and knowing when not to operate. For daily practice, control participants will be asked to devote 20 min per day to stress management through rest and exercise again reported daily by text.
Interventions
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Enhanced Stress Resilience Training (ESRT)
ESRT involves six weekly 90-minute group classes and one 2 - 4 hour retreat. Classes focus on developing mindfulness skills (i.e. sustained attention, open monitoring, emotional regulation, meta-cognition) in the context of skills and concepts for managing stress, particularly in practicing medicine. Homework consists of 20 minutes per day of mindfulness exercises following guided meditation CDs or videos of movement-based practice, and practice will be reported periodically by text. A 3-hour outdoor retreat occurs at week six. The central exercises of ESRT are the body scan, sitting meditation, chi gong and yoga. For both arms, the weekly teaching sessions occur on a workday morning during protected time at Parnassus, Mission Bay or Zuckerberg San Francisco General Hospital campus.
Active Control
Control group participants will meet for 6 weeks, 90 minutes each week, for classes focuses on stress management through rest and exercise, with equivalent protected time and small group bonding but without the use of contemplative practices. Topics will include the history of surgery, patient perspective, the physician personality, technical mastery, fallibility and limits, balancing compassion and detachment and knowing when not to operate. For daily practice, control participants will be asked to devote 20 min per day to stress management through rest and exercise again reported daily by text.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
Exclusion Criteria
* Use of medications with Central Nervous System effects;
* Lifetime history of an organic mental illness;
* Acute or chronic immune or inflammatory disorders;
* Pregnancy;
18 Years
64 Years
ALL
Yes
Sponsors
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University of California, San Francisco
OTHER
Responsible Party
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Principal Investigators
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Carter K Lebrares, MD
Role: PRINCIPAL_INVESTIGATOR
University of California, San Francisco
Locations
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University of California San Francisco
San Francisco, California, United States
Countries
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References
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Lebares CC, Guvva EV, Olaru M, Sugrue LP, Staffaroni AM, Delucchi KL, Kramer JH, Ascher NL, Harris HW. Efficacy of Mindfulness-Based Cognitive Training in Surgery: Additional Analysis of the Mindful Surgeon Pilot Randomized Clinical Trial. JAMA Netw Open. 2019 May 3;2(5):e194108. doi: 10.1001/jamanetworkopen.2019.4108.
Lebares CC, Coaston TN, Delucchi KL, Guvva EV, Shen WT, Staffaroni AM, Kramer JH, Epel ES, Hecht FM, Ascher NL, Harris HW, Cole SW. Enhanced Stress Resilience Training in Surgeons: Iterative Adaptation and Biopsychosocial Effects in 2 Small Randomized Trials. Ann Surg. 2021 Mar 1;273(3):424-432. doi: 10.1097/SLA.0000000000004145.
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Other Identifiers
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18-24601
Identifier Type: -
Identifier Source: org_study_id
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