Enhanced Stress Resilience Training for Residents (ESRT-R)

February 22, 2022 updated by: University of California, San Francisco

Enhanced Resilience Training to Improve Mental Health, Stress and Performance in Resident Physicians

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Actual)

45

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • California
      • San Francisco, California, United States, 94143
        • University of California San Francisco

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 64 years (Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

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;

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: 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).
Behavioral: 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.
Other Names:
  • Modified MBSR
Active Comparator: Active Control
Active control that emphasizes externalized attention via the "shared reading and listening" model.
Behavioral: 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change in executive function: National Institutes of Health Examiner battery
Time Frame: Baseline; post-intervention (9-10wk after baseline), 6 months follow-up.

Executive function as assessed via working memory capacity, cognitive control and executive composite components of the NIH EXAMINER battery.

NIH EXAMINER Battery measures working memory, inhibition, set shifting, fluency, planning, insight, and social cognition and behavior. The EXAMINER battery software calculates the executive composite and factor scores in the R language.
Baseline; post-intervention (9-10wk after baseline), 6 months follow-up.

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change in psychological well-being: Mental Health Continuum
Time Frame: Baseline; post-intervention (9-10wk after baseline), 6 months follow-up.
Mental Health Continuum Short Version consists of 14 items that were chosen as the most prototypical items representing the construct definition for each facet of well-being. 6-point Likert scale, from Never (0) to Every Day (5).
Baseline; post-intervention (9-10wk after baseline), 6 months follow-up.
Change in psychological well-being: Perceived Stress
Time Frame: Baseline; post-intervention (9-10wk after baseline), 6 months follow-up.
Cohen's Perceived Stress Scale: 10-items, 5-point Likert scale, 0-4. Stress is evaluated as continuous variable or as categorical variable, with high stress is score set at >20 for females and >18 for males.
Baseline; post-intervention (9-10wk after baseline), 6 months follow-up.
Change in psychological well-being: Burnout
Time Frame: Baseline; post-intervention (9-10wk after baseline), 6 months follow-up.
Burnout: 2-item Maslach Burnout Inventory, 7-point Likert scale, 0 to 6. High burnout present if either question scores ≥4.
Baseline; post-intervention (9-10wk after baseline), 6 months follow-up.
Change in psychological well-being: Anxiety
Time Frame: Baseline; post-intervention (9-10wk after baseline), 6 months follow-up.
Spielberger's State Trait Anxiety index, 4-point Likert, 1 to 4. High anxiety > 40.
Baseline; post-intervention (9-10wk after baseline), 6 months follow-up.
Change in psychological well-being: Depression
Time Frame: Baseline; post-intervention (9-10wk after baseline), 6 months follow-up.
Depression and Suicidal Ideation are assessed using the 9-item form of the Patient Health Questionnaire. 4-point Likert scale, 0 to 3 and a total score from 0 to 27 is calculated. Severe depression > 20.
Baseline; post-intervention (9-10wk after baseline), 6 months follow-up.
Change in psychological well-being: Mindfulness
Time Frame: Baseline; post-intervention (9-10wk after baseline), 6 months follow-up.
Cognitive and Affective Mindfulness Scale-Revised. 4-point Likert scale, 1 to 4. High mindfulness ≥ 31.
Baseline; post-intervention (9-10wk after baseline), 6 months follow-up.
Change in psychological well-being: Alcohol Misuse
Time Frame: Baseline; post-intervention (9-10wk after baseline), 6 months follow-up.
The AUDIT Alcohol Consumption Questions, 5-point Likert scale, 0 to 4. Misuse for females if score ≥ 3, for males if score ≥ 4.
Baseline; post-intervention (9-10wk after baseline), 6 months follow-up.

Other Outcome Measures

Outcome Measure
Measure Description
Time Frame
Functional neuroanatomic changes
Time Frame: Baseline; post-intervention (9-10wk after baseline), 6 months follow-up.
Functional changes in areas associated with reappraisal/emotional regulation (amygdala, hippocampus, reward circuitry, appraisal pathway) as evidenced by fMRI BOLD and DTI brain scans analyzed by whole brain and a prior region of interest approaches.
Baseline; post-intervention (9-10wk after baseline), 6 months follow-up.
Motor skills
Time Frame: Baseline; 6 weeks post-intervention (9-10wk after baseline), 6 months follow-up.
Performance as assessed by the Fundamentals of Laparoscopic Surgery (FLS) modules
Baseline; 6 weeks post-intervention (9-10wk after baseline), 6 months follow-up.
Mind-Wandering
Time Frame: Baseline; post-intervention (9-10wk after baseline), 6 months follow-up.
The Mind-Wandering Questionnaire, 5 item scale that is measured the frequency of mind-wandering. 6-point Likert scale, 1 to 6. The total is the sum of the five items within a 5-30 range.
Baseline; post-intervention (9-10wk after baseline), 6 months follow-up.
Change in Emotional Regulation: Decentering
Time Frame: Baseline; post-intervention (9-10wk after baseline), 6 months follow-up.
The Experiences Questionnaire is a 12 item instrument that assesses decentering. 5-point Likert scale,1 to 5.
Baseline; post-intervention (9-10wk after baseline), 6 months follow-up.
Change in Performance: Consultation and Relational Empathy
Time Frame: Baseline; post-intervention (9-10wk after baseline), 6 months follow-up.
The Consultation and Relational Empathy Measure is a validated 10-item questionnaire measuring patient perceptions of empathetic behaviors. 5-point Likert scale from "poor (1)" to "excellent (5)". Score is totaled (10-50 points), with higher scores indicating more empathic behavior.
Baseline; post-intervention (9-10wk after baseline), 6 months follow-up.
Change in Performance: Patient Experience
Time Frame: Baseline; post-intervention (9-10wk after baseline), 6 months follow-up.
The Patient Enablement Instrument is a six-item questionnaire measuring enablement, a concept related to patient satisfaction, but more specific to the physician's patient-centeredness and empowerment. 3-point Likert scale of "much better," "better," and "same or less." Score is totaled (0-12 points), with higher scores indicating greater enablement.
Baseline; post-intervention (9-10wk after baseline), 6 months follow-up.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of California, San Francisco

Investigators

  • Principal Investigator: Carter K Lebrares, MD, University of California, San Francisco

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

June 13, 2018

Primary Completion (Actual)

June 30, 2021

Study Completion (Actual)

June 30, 2021

Study Registration Dates

First Submitted

April 24, 2018

First Submitted That Met QC Criteria

May 4, 2018

First Posted (Actual)

May 8, 2018

Study Record Updates

Last Update Posted (Actual)

February 24, 2022

Last Update Submitted That Met QC Criteria

February 22, 2022

Last Verified

February 1, 2022

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • 18-24601

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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