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Enhanced Stress Resilience Training for Residents (ESRT-R)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03518359
Recruitment Status : Active, not recruiting
First Posted : May 8, 2018
Last Update Posted : September 27, 2019
Sponsor:
Information provided by (Responsible Party):
University of California, San Francisco

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.

Condition or disease Intervention/treatment Phase
Stress Mindfulness Cognitive Change Behavioral: Enhanced Stress Resilience Training (ESRT) Behavioral: Active Control Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 45 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: Randomized, partially-blinded.
Masking: Double (Participant, Outcomes Assessor)
Masking Description: Participants do not know that the investigator is testing mindfulness. Participants only will be told that they will be learning stress-reduction skills for physicians.
Primary Purpose: Prevention
Official Title: Enhanced Resilience Training to Improve Mental Health, Stress and Performance in Resident Physicians
Actual Study Start Date : June 13, 2018
Estimated Primary Completion Date : June 2021
Estimated Study Completion Date : June 2022

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 Name: 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.




Primary Outcome Measures :
  1. 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.



Secondary Outcome Measures :
  1. 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).

  2. 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.

  3. 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.

  4. 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.

  5. 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.

  6. 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.

  7. 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.


Other Outcome Measures:
  1. 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.

  2. 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

  3. 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.

  4. 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.

  5. 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.

  6. 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.



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 64 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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;

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03518359


Locations
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United States, California
University of California San Francisco
San Francisco, California, United States, 94143
Sponsors and Collaborators
University of California, San Francisco
Investigators
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Principal Investigator: Carter K Lebrares, MD University of California, San Francisco
Publications of Results:

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: University of California, San Francisco
ClinicalTrials.gov Identifier: NCT03518359    
Other Study ID Numbers: 18-24601
First Posted: May 8, 2018    Key Record Dates
Last Update Posted: September 27, 2019
Last Verified: September 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by University of California, San Francisco:
Residents
Stress
Well-being