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Enhanced Stress Resilience Training for Faculty (ESRT-Faculty)

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ClinicalTrials.gov Identifier: NCT03516877
Recruitment Status : Active, not recruiting
First Posted : May 4, 2018
Last Update Posted : January 6, 2020
Sponsor:
Information provided by (Responsible Party):
University of California, San Francisco

Tracking Information
First Submitted Date  ICMJE April 6, 2018
First Posted Date  ICMJE May 4, 2018
Last Update Posted Date January 6, 2020
Actual Study Start Date  ICMJE July 9, 2018
Estimated Primary Completion Date December 2020   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: May 29, 2019)
  • Change in Psychological Well-being: Burnout [ Time Frame: Baseline; 6 weeks (post-intervention); 12 and 18 month follow-up. ]
    Burnout: 2-item Maslach Burnout Inventory, 7-point Likert scale, 0 to 6. High burnout present if either question scores >= 4.
  • Change in Psychological Well-being: Perceived Stress [ Time Frame: Baseline; 6 weeks (post-intervention); 12 and 18 month follow-up. ]
    Cohen's Perceived Stress Scale: 10-items, 5-point Likert scale, 0-4. High stress is score >17.
  • Change in Psychological Well-being: Anxiety [ Time Frame: Baseline; 6 weeks (post-intervention); 12 and 18 month follow-up. ]
    Spielberger's State Trait Anxiety index, 4-point Likert, 1 to 4. High anxiety > 40.
  • Change in Psychological Well-being: Depression [ Time Frame: Baseline; 6 weeks (post-intervention); 12 and 18 month 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.
  • Change in Psychological Well-being: Mindfulness [ Time Frame: Baseline; 6 weeks (post-intervention); 12 and 18 month follow-up. ]
    Cognitive and Affective Mindfulness Scale-Revised. 4-point Likert scale, 1 to 4. High mindfulness ≥ 31.
  • Change in Psychological Well-being: Alcoholism [ Time Frame: Baseline; 6 weeks (post-intervention); 12 and 18 month 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.
  • Change in Psychological Well-being: Work Climate [ Time Frame: Baseline; 6 weeks (post-intervention); 12 and 18 month follow-up. ]
    The Swedish Demand-Control-Support Questionnaire assess work climate. 4-point Likert scale, 1 to 4.
  • Change in Psychological Well-being: Mental Health [ Time Frame: Baseline; 6 weeks (post-intervention); 12 and 18 month follow-up. ]
    The short form of the Mental Health Continuum assess various facets of well-being. 6-point Likert scale, 0 to 5.
  • Change in Psychological Well-being: Perceived Stress Reactivity [ Time Frame: Baseline; 6 weeks (post-intervention); 12 and 18 month follow-up. ]
    The Perceived Stress Reactivity Scale is a 23-item questionnaire with 5 subscales (Prolonged Reactivity; Reactivity to Work Overload; Reactivity to Social Conflict; Reactivity to Failure; Reactivity to Social Evaluation), and 1 overall scale (Perceived Stress Reactivity total score). The first answer category of each item is coded 0, the second 1, and the third 2.
  • Change in Psychological Well-being: Mental Disorders [ Time Frame: Baseline; 6 weeks (post-intervention); 12 and 18 month follow-up. ]
    The Primary Care Evaluation of Mental Disorders Patient Health Questionnaire (PRIME-MD PHQ). This is a 2 item screening instrument used for the assessment of depression with an answer of "yes" to either question indicating a positive response where the respondent displayed traits of possible depression.
Original Primary Outcome Measures  ICMJE
 (submitted: May 2, 2018)
  • Change in Psychological Well-being: Burnout [ Time Frame: Baseline; 6 weeks (post-intervention); 12 and 18 month follow-up. ]
    Burnout: 2-item Maslach Burnout Inventory, 7-point Likert scale, 0 to 6. High burnout present if either question scores >= 4.
  • Change in Psychological Well-being: Perceived Stress [ Time Frame: Baseline; 6 weeks (post-intervention); 12 and 18 month follow-up. ]
    Cohen's Perceived Stress Scale: 10-items, 5-point Likert scale, 0-4. High stress is score >17.
  • Change in Psychological Well-being: Anxiety [ Time Frame: Baseline; 6 weeks (post-intervention); 12 and 18 month follow-up. ]
    Spielberger's State Trait Anxiety index, 4-point Likert, 1 to 4. High anxiety > 40.
  • Change in Psychological Well-being: Depression [ Time Frame: Baseline; 6 weeks (post-intervention); 12 and 18 month 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.
  • Change in Psychological Well-being: Mindfulness [ Time Frame: Baseline; 6 weeks (post-intervention); 12 and 18 month follow-up. ]
    Cognitive and Affective Mindfulness Scale-Revised. 4-point Likert scale, 1 to 4. High mindfulness ≥ 31.
  • Change in Psychological Well-being: Alcoholism [ Time Frame: Baseline; 6 weeks (post-intervention); 12 and 18 month 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.
  • Change in Psychological Well-being: Sleep [ Time Frame: Baseline; 6 weeks (post-intervention); 12 and 18 month follow-up. ]
    Pittsburgh Sleep Quality Index, 4-point Likert scale, 0 to 3. Poor sleep quality ≥ 5.
  • Change in Psychological Well-being: Work Climate [ Time Frame: Baseline; 6 weeks (post-intervention); 12 and 18 month follow-up. ]
    The Swedish Demand-Control-Support Questionnaire assess work climate. 4-point Likert scale, 1 to 4.
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: May 29, 2019)
  • Change in Performance: Strategies [ Time Frame: Baseline; 6 weeks (post-intervention); 12 and 18 month follow-up. ]
    The Test of Performance Strategies-2 is a 68-item self-report instrument that measures a comprehensive range of psychological skills that have been shown to impact successful performance: goal-setting, imagery, self-talk, relaxation, activation, emotional control, and automaticity. 5 point Likert Scale, 1 to 5.
  • Change in Performance: Psychological Skills [ Time Frame: Baseline; 6 weeks (post-intervention); 12 and 18 month follow-up. ]
    The Test of Performance Strategies-2 is a 68-item self-report instrument that measures a comprehensive range of psychological skills that have been shown to impact successful performance: goal-setting, imagery, self-talk, relaxation, activation, emotional control, and automaticity. 5 point Likert Scale, 1 to 5.
  • Change in Emotional Regulation: Mind-Wandering [ Time Frame: Baseline; 6 weeks (post-intervention); 12 and 18 month 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.
  • Change in Emotional Regulation: Emotions [ Time Frame: Baseline; 6 weeks (post-intervention); 12 and 18 month follow-up. ]
    The Difficulties in Emotion Regulation Scale, an 18 item scale focuses on adaptive ways of responding to emotional distress. 5-point Likert scale, 1 to 5. The total score is sum the subscale scores.
  • Change in Emotional Regulation: Decentering [ Time Frame: Baseline; 6 weeks (post-intervention); 12 and 18 month follow-up. ]
    The Experiences Questionnaire is a 12 item instrument that assesses decentering. 5-point Likert scale,1 to 5.
  • Change in Cognitive Function [ Time Frame: Baseline; 6 weeks (post-intervention); 12 and 18 month follow-up. ]
    Outcome contains: 1. 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. 2. The Cambridge Neuropsychological Test Automated Battery measures:
    1. Reaction Time - assessments of motor and mental response speeds, measures of movement time, reaction time, response accuracy and impulsivity. Outcome measures are divided into reaction time and movement time for both the simple and five-choice variants.
    2. Rapid Visual Information Processing is a measure of sustained attention. Outcome measures cover latency, probability of false alarms and sensitivity.
    3. Paired Associates Learning assesses visual memory and new learning. Outcome measures include the errors made by the participant, the number of trials required to locate the patterns correctly, memory scores and stages completed.
  • Change in Cognitive Function: NIH EXAMINER Battery [ Time Frame: Baseline; 6 weeks (post-intervention); 12 and 18 month follow-up. ]
    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.
Original Secondary Outcome Measures  ICMJE
 (submitted: May 2, 2018)
  • Change in Performance: Strategies [ Time Frame: Baseline; 6 weeks (post-intervention); 12 and 18 month follow-up. ]
    The Test of Performance Strategies-2 is a 68-item self-report instrument that measures a comprehensive range of psychological skills that have been shown to impact successful performance: goal-setting, imagery, self-talk, relaxation, activation, emotional control, and automaticity. 5 point Likert Scale, 1 to 5.
  • Change in Performance: Psychological Skills [ Time Frame: Baseline; 6 weeks (post-intervention); 12 and 18 month follow-up. ]
    The Test of Performance Strategies-2 is a 68-item self-report instrument that measures a comprehensive range of psychological skills that have been shown to impact successful performance: goal-setting, imagery, self-talk, relaxation, activation, emotional control, and automaticity. 5 point Likert Scale, 1 to 5.
  • Change in Emotional Regulation: Mind-Wandering [ Time Frame: Baseline; 6 weeks (post-intervention); 12 and 18 month 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.
  • Change in Emotional Regulation: Emotions [ Time Frame: Baseline; 6 weeks (post-intervention); 12 and 18 month follow-up. ]
    The Difficulties in Emotion Regulation Scale, an 18 item scale focuses on adaptive ways of responding to emotional distress. 5-point Likert scale, 1 to 5. The total score is sum the subscale scores.
  • Change in Emotional Regulation: Decentering [ Time Frame: Baseline; 6 weeks (post-intervention); 12 and 18 month follow-up. ]
    The Experiences Questionnaire is a 12 item instrument that assesses decentering. 5-point Likert scale,1 to 5.
  • Change in Emotional Regulation: Interoceptive Awareness [ Time Frame: Baseline; 6 weeks (post-intervention); 12 and 18 month follow-up. ]
    Multidimensional Assessment of Interoceptive Awareness is 32-item scale that measures interoceptive awareness. 6 point Likert scale, 0 to 5.
  • Change in Cognitive Function [ Time Frame: Baseline; 6 weeks (post-intervention); 12 and 18 month follow-up. ]
    Outcome contains: 1. 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. 2. The Cambridge Neuropsychological Test Automated Battery measures:
    1. Reaction Time - assessments of motor and mental response speeds, measures of movement time, reaction time, response accuracy and impulsivity. Outcome measures are divided into reaction time and movement time for both the simple and five-choice variants.
    2. Rapid Visual Information Processing is a measure of sustained attention. Outcome measures cover latency, probability of false alarms and sensitivity.
    3. Paired Associates Learning assesses visual memory and new learning. Outcome measures include the errors made by the participant, the number of trials required to locate the patterns correctly, memory scores and stages completed.
  • Change in Cognitive Function: NIH EXAMINER Battery [ Time Frame: Baseline; 6 weeks (post-intervention); 12 and 18 month follow-up. ]
    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.
  • Change in Cognitive Function: The Cambridge Neuropsychological Test Automated Battery [ Time Frame: Baseline; 6 weeks (post-intervention); 12 and 18 month follow-up. ]
    The Cambridge Neuropsychological Test Automated Battery measures:
    1. Reaction Time - assessments of motor and mental response speeds, measures of movement time, reaction time, response accuracy and impulsivity. Outcome measures are divided into reaction time and movement time for both the simple and five-choice variants.
    2. Rapid Visual Information Processing is a measure of sustained attention. Outcome measures cover latency, probability of false alarms and sensitivity.
    3. Paired Associates Learning assesses visual memory and new learning. Outcome measures include the errors made by the participant, the number of trials required to locate the patterns correctly, memory scores and stages completed.
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Enhanced Stress Resilience Training for Faculty
Official Title  ICMJE Enhanced Stress Resilience Training for Faculty Physicians
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.

Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Burnout, Professional
Intervention  ICMJE Behavioral: Enhanced Stress Resilience Training for Faculty Physicians
Enhanced Stress Resilience Training (ESRT) is derived from Mindfulness-Based Stress Reduction with modifications to language, activities and contextualization to tailor the training to physicians involved in the operating room environment. ESRT consists of 5 weekly 1-hour group classes and 2-4 hour retreat. Classes focus on developing sustained attention and open monitoring in addition to training focused on stress and coping. Increasing duration (3-20 minutes per day) of guided mindfulness exercises are assigned each week. A 2-4 hour intensive retreat occurs at week 4 or 5. The central exercises of the training are the body scan, sitting meditation, qi gong and yoga. The weekly teaching sessions will be offered at various days and times each week in order to accommodate complicated physicians schedules that vary at each site. Participants can attend whichever session is most convenient. Daily practice will occur independently, with the duration reported weekly through text or email.
Other Name: ESRT
Study Arms  ICMJE Experimental: ESRT

Volunteer surgery and anesthesia faculty from UCSF working at Parnassus Hospital site and interested in training.

Volunteer surgery and anesthesia faculty from UCSF working at Zuckerberg San Francisco General Hospital site and interested in training.

Volunteer surgery and anesthesia faculty from UCSF working at Mission Bay Hospital site and interested in training.

Intervention: Behavioral: Enhanced Stress Resilience Training for Faculty Physicians
Publications *

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Active, not recruiting
Estimated Enrollment  ICMJE
 (submitted: September 30, 2019)
56
Original Estimated Enrollment  ICMJE
 (submitted: May 2, 2018)
100
Estimated Study Completion Date  ICMJE December 2020
Estimated Primary Completion Date December 2020   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Exclusion Criteria:

- Lifetime history of an organic mental illness.

Inclusion Criteria:

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

Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 64 Years   (Adult)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03516877
Other Study ID Numbers  ICMJE 18-24596
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Responsible Party University of California, San Francisco
Study Sponsor  ICMJE University of California, San Francisco
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Carter C Lebares, MD University of California, San Francisco
PRS Account University of California, San Francisco
Verification Date January 2020

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP