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Enhanced Stress Resilience Training for Faculty (ESRT-Faculty)

Primary Purpose

Burnout, Professional

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Enhanced Stress Resilience Training for Faculty Physicians
Sponsored by
University of California, San Francisco
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Burnout, Professional focused on measuring Mindfulness-Bases Stress Reduction, Stress, Resilience, Well-being

Eligibility Criteria

18 Years - 64 Years (Adult)All SexesAccepts Healthy Volunteers

Exclusion Criteria:

- Lifetime history of an organic mental illness.

Inclusion Criteria:

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

Sites / Locations

  • University of California San Francisco

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

ESRT

Arm Description

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.

Outcomes

Primary Outcome Measures

Change in Psychological Well-being: Burnout
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
Cohen's Perceived Stress Scale: 10-items, 5-point Likert scale, 0-4. High stress is score >17.
Change in Psychological Well-being: Anxiety
Spielberger's State Trait Anxiety index, 4-point Likert, 1 to 4. High anxiety > 40.
Change in Psychological Well-being: Depression
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
Cognitive and Affective Mindfulness Scale-Revised. 4-point Likert scale, 1 to 4. High mindfulness ≥ 31.
Change in Psychological Well-being: Alcoholism
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
The Swedish Demand-Control-Support Questionnaire assess work climate. 4-point Likert scale, 1 to 4.
Change in Psychological Well-being: Mental Health
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
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
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.

Secondary Outcome Measures

Change in Performance: Strategies
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
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
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
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
The Experiences Questionnaire is a 12 item instrument that assesses decentering. 5-point Likert scale,1 to 5.
Change in Cognitive Function
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: 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. Rapid Visual Information Processing is a measure of sustained attention. Outcome measures cover latency, probability of false alarms and sensitivity. 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
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.

Full Information

First Posted
April 6, 2018
Last Updated
October 25, 2021
Sponsor
University of California, San Francisco
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1. Study Identification

Unique Protocol Identification Number
NCT03516877
Brief Title
Enhanced Stress Resilience Training for Faculty
Acronym
ESRT-Faculty
Official Title
Enhanced Stress Resilience Training for Faculty Physicians
Study Type
Interventional

2. Study Status

Record Verification Date
October 2021
Overall Recruitment Status
Completed
Study Start Date
July 9, 2018 (Actual)
Primary Completion Date
December 1, 2020 (Actual)
Study Completion Date
December 1, 2020 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University of California, San Francisco

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Burnout, Professional
Keywords
Mindfulness-Bases Stress Reduction, Stress, Resilience, Well-being

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
48 (Actual)

8. Arms, Groups, and Interventions

Arm Title
ESRT
Arm Type
Experimental
Arm Description
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 Type
Behavioral
Intervention Name(s)
Enhanced Stress Resilience Training for Faculty Physicians
Other Intervention Name(s)
ESRT
Intervention Description
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.
Primary Outcome Measure Information:
Title
Change in Psychological Well-being: Burnout
Description
Burnout: 2-item Maslach Burnout Inventory, 7-point Likert scale, 0 to 6. High burnout present if either question scores >= 4.
Time Frame
Baseline; 6 weeks (post-intervention); 12 and 18 month follow-up.
Title
Change in Psychological Well-being: Perceived Stress
Description
Cohen's Perceived Stress Scale: 10-items, 5-point Likert scale, 0-4. High stress is score >17.
Time Frame
Baseline; 6 weeks (post-intervention); 12 and 18 month follow-up.
Title
Change in Psychological Well-being: Anxiety
Description
Spielberger's State Trait Anxiety index, 4-point Likert, 1 to 4. High anxiety > 40.
Time Frame
Baseline; 6 weeks (post-intervention); 12 and 18 month follow-up.
Title
Change in Psychological Well-being: Depression
Description
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.
Time Frame
Baseline; 6 weeks (post-intervention); 12 and 18 month follow-up.
Title
Change in Psychological Well-being: Mindfulness
Description
Cognitive and Affective Mindfulness Scale-Revised. 4-point Likert scale, 1 to 4. High mindfulness ≥ 31.
Time Frame
Baseline; 6 weeks (post-intervention); 12 and 18 month follow-up.
Title
Change in Psychological Well-being: Alcoholism
Description
The AUDIT Alcohol Consumption Questions, 5-point Likert scale, 0 to 4. Misuse for females if score ≥ 3, for males if score ≥ 4.
Time Frame
Baseline; 6 weeks (post-intervention); 12 and 18 month follow-up.
Title
Change in Psychological Well-being: Work Climate
Description
The Swedish Demand-Control-Support Questionnaire assess work climate. 4-point Likert scale, 1 to 4.
Time Frame
Baseline; 6 weeks (post-intervention); 12 and 18 month follow-up.
Title
Change in Psychological Well-being: Mental Health
Description
The short form of the Mental Health Continuum assess various facets of well-being. 6-point Likert scale, 0 to 5.
Time Frame
Baseline; 6 weeks (post-intervention); 12 and 18 month follow-up.
Title
Change in Psychological Well-being: Perceived Stress Reactivity
Description
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.
Time Frame
Baseline; 6 weeks (post-intervention); 12 and 18 month follow-up.
Title
Change in Psychological Well-being: Mental Disorders
Description
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.
Time Frame
Baseline; 6 weeks (post-intervention); 12 and 18 month follow-up.
Secondary Outcome Measure Information:
Title
Change in Performance: Strategies
Description
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.
Time Frame
Baseline; 6 weeks (post-intervention); 12 and 18 month follow-up.
Title
Change in Performance: Psychological Skills
Description
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.
Time Frame
Baseline; 6 weeks (post-intervention); 12 and 18 month follow-up.
Title
Change in Emotional Regulation: Mind-Wandering
Description
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.
Time Frame
Baseline; 6 weeks (post-intervention); 12 and 18 month follow-up.
Title
Change in Emotional Regulation: Emotions
Description
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.
Time Frame
Baseline; 6 weeks (post-intervention); 12 and 18 month follow-up.
Title
Change in Emotional Regulation: Decentering
Description
The Experiences Questionnaire is a 12 item instrument that assesses decentering. 5-point Likert scale,1 to 5.
Time Frame
Baseline; 6 weeks (post-intervention); 12 and 18 month follow-up.
Title
Change in Cognitive Function
Description
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: 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. Rapid Visual Information Processing is a measure of sustained attention. Outcome measures cover latency, probability of false alarms and sensitivity. 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.
Time Frame
Baseline; 6 weeks (post-intervention); 12 and 18 month follow-up.
Title
Change in Cognitive Function: NIH EXAMINER Battery
Description
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.
Time Frame
Baseline; 6 weeks (post-intervention); 12 and 18 month follow-up.

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
64 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Carter C Lebares, MD
Organizational Affiliation
University of California, San Francisco
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of California San Francisco
City
San Francisco
State/Province
California
ZIP/Postal Code
94143
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
No
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Enhanced Stress Resilience Training for Faculty

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