Clinical trial NCT03518359: Enhanced Stress Resilience Training for Residents
Official title: Enhanced Resilience Training to Improve Mental Health, Stress and Performance in Resident Physicians
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Stress
Mindfulness
Cognitive Change
Keywords: Residents
Stress
Well-being
Lead sponsor: University of California, San Francisco
Sponsor class: OTHER
First posted: 2018-05-08
Enrollment: 45
Sex: ALL
Minimum age (years): 18
Maximum age (years): 64
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Randomized, partially-blinded.
Primary purpose: PREVENTION

Brief 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 surgical and non-surgical residents evaluated for well-being, cognition and performance changes at baseline, post-intervention and six-month follow-up.

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 is being linked to diminished physician performance, patient outcomes, and hospital economics. This suggests that demands are outstripping resources, thereby 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, 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.

Eligibility criteria: 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, once a week or more frequent;
* Use of medications with Central Nervous System effects;
* Lifetime history of an organic mental illness;
* Acute or chronic immune or inflammatory disorders;
* Pregnancy;

Primary outcomes:
measure: Change in executive function: National Institutes of Health Examiner battery
timeFrame: Baseline; post-intervention (9-10wk after baseline), 6 months follow-up.
Secondary outcomes:
measure: Change in psychological well-being: Mental Health Continuum
timeFrame: Baseline; post-intervention (9-10wk after baseline), 6 months follow-up.
measure: Change in psychological well-being: Perceived Stress
timeFrame: Baseline; post-intervention (9-10wk after baseline), 6 months follow-up.
measure: Change in psychological well-being: Burnout
timeFrame: Baseline; post-intervention (9-10wk after baseline), 6 months follow-up.
measure: Change in psychological well-being: Anxiety
timeFrame: Baseline; post-intervention (9-10wk after baseline), 6 months follow-up.
measure: Change in psychological well-being: Depression
timeFrame: Baseline; post-intervention (9-10wk after baseline), 6 months follow-up.
measure: Change in psychological well-being: Mindfulness
timeFrame: Baseline; post-intervention (9-10wk after baseline), 6 months follow-up.
measure: Change in psychological well-being: Alcohol Misuse
timeFrame: Baseline; post-intervention (9-10wk after baseline), 6 months follow-up.
Other outcomes:
measure: Functional neuroanatomic changes
timeFrame: Baseline; post-intervention (9-10wk after baseline), 6 months follow-up.
measure: Motor skills
timeFrame: Baseline; 6 weeks post-intervention (9-10wk after baseline), 6 months follow-up.
measure: Mind-Wandering
timeFrame: Baseline; post-intervention (9-10wk after baseline), 6 months follow-up.
measure: Change in Emotional Regulation: Decentering
timeFrame: Baseline; post-intervention (9-10wk after baseline), 6 months follow-up.
measure: Change in Performance: Consultation and Relational Empathy
timeFrame: Baseline; post-intervention (9-10wk after baseline), 6 months follow-up.
measure: Change in Performance: Patient Experience
timeFrame: Baseline; post-intervention (9-10wk after baseline), 6 months follow-up.
Locations:
city: San Francisco
country: United States
facility: University of California San Francisco
state: California
Study officials:
affiliation: University of California, San Francisco
name: Carter K Lebrares, MD
role: PRINCIPAL_INVESTIGATOR
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