Clinical trial NCT03516877: Enhanced Stress Resilience Training for Faculty
Official title: Enhanced Stress Resilience Training for Faculty Physicians
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Burnout, Professional
Keywords: Mindfulness-Bases Stress Reduction, Stress, Resilience, Well-being
Lead sponsor: University of California, San Francisco
Sponsor class: OTHER
First posted: 2018-05-04
Enrollment: 48
Sex: ALL
Minimum age (years): 18
Maximum age (years): 64
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: Mounting evidence shows that burnout, a critical metric for dissatisfaction and distress, is a growing problem within medicine. Burnout is a syndrome associated with worse physician performance, patient outcomes, and hospital economics. Furthermore, researchers are coming to understand that burnout, diminished performance and the development of mental and physical illness are related. It has been proposed that chronic and overwhelming stress, in the absence of adequate coping skills, promotes performance deficits from surgical errors to poor professionalism due to the effects of stress on cognition.

Notably, in small studies of physicians and other high-stress/high-performance groups mindfulness-based interventions have shown exceptional promise in improving burnout and distress symptoms, protecting cognition, and enhancing meaningfulness and satisfaction in work. Nevertheless, in spite of promising results in various populations the translation of mindfulness-based interventions to real-world settings has been slow.

There is a paucity of quality research examining individually-based interventions, formal mindfulness training in physicians, or either of these things in the high stakes world of surgeons and anesthesiologists. To address these gaps, researchers have developed Enhanced Stress-Resilience Training (ESRT) based on MBSR, but streamlined and tailored for surgeons and anesthesiologists.

Moreover, researchers have refined the scales included in our psychosocial survey of well-being in order to sharpen our approach to the complex issue of physician well-being and factors influencing physician resilience, within Surgery and Anesthesia, at UCSF.

Detailed description: Burnout, which comprises emotional exhaustion, depersonalization and diminished satisfaction with one's work, has been documented in medical students, trainees, and practicing physicians across specialties, including 69% of surgical residents and 40-60% of practicing physicians.

Furthermore, a strong correlation between burnout, impaired performance and the development of mental and physical illness is coming to light. It has been proposed that chronic and overwhelming stress, in the absence of adequate coping skills, promotes burnout and associated distress symptoms such as depression, suicidal ideation and anxiety. Among physicians, performance deficits from surgical errors to poor professionalism have been proposed to result from the effects of stress on cognition. Notably, in other high-stress/high-performance groups, mindfulness-based interventions (MBIs) have shown promise in reducing distress symptoms, protecting cognition, and enhancing performance. Among physicians, limited studies of MBIs have shown improvements in burnout and the sense of meaningfulness and satisfaction in work. Nevertheless, in spite of such evidence, MBIs have yet to be tested in surgeons and have made little progress being translated to real-world settings within healthcare.

Interestingly, our cross-sectional national survey of general surgery residents found that high dispositional mindfulness reduces the risk of emotional exhaustion, depersonalization, moderate to severe depression and suicidal ideation, by 75% or more. This suggests that while mindfulness may seem out of place among surgeons and operating room culture, it is in fact already in use in this setting, albeit unconsciously. More importantly, it appears to be beneficial. These findings, in combination with promising preliminary data from our longitudinal RCT of mindfulness training in surgical interns, suggested that an appropriate MBI could enhance native skills and potentially become a powerful component of stress resilience training among surgeons and anesthesiologists. Therefore, through iterative work in surgical trainees, researchers have created a streamlined, modular MBI for surgery and anesthesia faculty physicians and aim to test it both for pragmatic feasibility and for efficacy at enhancing stress resilience and improving wellbeing.

The significance of this work lies in evaluating a process-centered skill believed to promote resilience, defined as the ability to thrive under adversity and predicated on the perception of stressors as challenges rather than overwhelming threats. The transformation of how people experience stress is a learned skill that can be applied across career stages, practice trajectories and life. The potential to protect individuals, while researchers work for mandatory institutional and systemic change, is powerful. Moreover, the resultant tendency for self-awareness and equipoise has been contagious in other settings, providing fuel for the greater culture change that is inarguably necessary and holds great promise for us and our patients.

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 attention, working memory capacity, emotional regulation and self-awareness, which may impact behaviors such as medical decision-making, professionalism and team work. The potential to improve both the operative environment and surgical or medical errors is unprecedented. Moreover, the use of a manualized curriculum specifically crafted for physicians could pave the way for translation to larger studies, other specialties and outside institutions.

Eligibility criteria: Exclusion Criteria:

- Lifetime history of an organic mental illness.

Inclusion Criteria:

- Any consented surgery or anesthesia faculty who does not meet exclusion criteria.

Primary outcomes:
measure: Change in Psychological Well-being: Burnout
timeFrame: Baseline; 6 weeks (post-intervention); 12 and 18 month follow-up.
measure: Change in Psychological Well-being: Perceived Stress
timeFrame: Baseline; 6 weeks (post-intervention); 12 and 18 month follow-up.
measure: Change in Psychological Well-being: Anxiety
timeFrame: Baseline; 6 weeks (post-intervention); 12 and 18 month follow-up.
measure: Change in Psychological Well-being: Depression
timeFrame: Baseline; 6 weeks (post-intervention); 12 and 18 month follow-up.
measure: Change in Psychological Well-being: Mindfulness
timeFrame: Baseline; 6 weeks (post-intervention); 12 and 18 month follow-up.
measure: Change in Psychological Well-being: Alcoholism
timeFrame: Baseline; 6 weeks (post-intervention); 12 and 18 month follow-up.
measure: Change in Psychological Well-being: Work Climate
timeFrame: Baseline; 6 weeks (post-intervention); 12 and 18 month follow-up.
measure: Change in Psychological Well-being: Mental Health
timeFrame: Baseline; 6 weeks (post-intervention); 12 and 18 month follow-up.
measure: Change in Psychological Well-being: Perceived Stress Reactivity
timeFrame: Baseline; 6 weeks (post-intervention); 12 and 18 month follow-up.
measure: Change in Psychological Well-being: Mental Disorders
timeFrame: Baseline; 6 weeks (post-intervention); 12 and 18 month follow-up.
Secondary outcomes:
measure: Change in Performance: Strategies
timeFrame: Baseline; 6 weeks (post-intervention); 12 and 18 month follow-up.
measure: Change in Performance: Psychological Skills
timeFrame: Baseline; 6 weeks (post-intervention); 12 and 18 month follow-up.
measure: Change in Emotional Regulation: Mind-Wandering
timeFrame: Baseline; 6 weeks (post-intervention); 12 and 18 month follow-up.
measure: Change in Emotional Regulation: Emotions
timeFrame: Baseline; 6 weeks (post-intervention); 12 and 18 month follow-up.
measure: Change in Emotional Regulation: Decentering
timeFrame: Baseline; 6 weeks (post-intervention); 12 and 18 month follow-up.
measure: Change in Cognitive Function
timeFrame: Baseline; 6 weeks (post-intervention); 12 and 18 month follow-up.
measure: Change in Cognitive Function: NIH EXAMINER Battery
timeFrame: Baseline; 6 weeks (post-intervention); 12 and 18 month follow-up.
Other outcomes:
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 C Lebares, MD
role: PRINCIPAL_INVESTIGATOR
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