Burnout, ProfessionalESRT-FacultyNCT03516877
Enhanced Stress Resilience Training for Faculty
A study testing Enhanced Stress Resilience Training for Faculty Physicians in people with Burnout, Professional, run by University of California, San Francisco at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 64 yearsHealthy volunteers can take part
- Conditions the study is for
- Burnout, Professional
- What is being tested?
- Enhanced Stress Resilience Training for Faculty Physicians
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 48 participants
- Where
- 1 siteUnited States
- Study dates
- 9 Jul 2018to 1 Dec 2020
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 64 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Any consented surgery or anesthesia faculty who does not meet exclusion criteria.
Who cannot join
- Lifetime history of an organic mental illness.
Trial locations and contacts
1 site in 1 country.
United States1 site
University of California San Francisco
San Francisco, California, 94143
About this study
Official title: Enhanced Stress Resilience Training for Faculty Physicians
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.
Read more
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.
Read the 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.
- Conditions
- Burnout, Professional
- Being tested
- Enhanced Stress Resilience Training for Faculty Physicians
- Keywords
- Mindfulness-Bases Stress Reduction, Stress, Resilience, Well-being
- Medical subject headings
- Burnout, Professional
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Enhanced Stress Resilience Training for Faculty PhysiciansBehavioural
Also called ESRT
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.
| Study group | Role | What they receive |
|---|---|---|
| ESRT | Experimental | 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. Receives: Behavioral: Enhanced Stress Resilience Training for Faculty Physicians |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Baseline; 6 weeks (post-intervention); 12 and 18 month follow-up.
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.
Measured: Baseline; 6 weeks (post-intervention); 12 and 18 month follow-up.
Change in Psychological Well-being: Anxiety
Spielberger's State Trait Anxiety index, 4-point Likert, 1 to 4. High anxiety > 40.
Measured: Baseline; 6 weeks (post-intervention); 12 and 18 month follow-up.
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.
Measured: Baseline; 6 weeks (post-intervention); 12 and 18 month follow-up.
Change in Psychological Well-being: Mindfulness
Cognitive and Affective Mindfulness Scale-Revised. 4-point Likert scale, 1 to 4. High mindfulness ≥ 31.
Measured: Baseline; 6 weeks (post-intervention); 12 and 18 month follow-up.
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.
Measured: Baseline; 6 weeks (post-intervention); 12 and 18 month follow-up.
Change in Psychological Well-being: Work Climate
The Swedish Demand-Control-Support Questionnaire assess work climate. 4-point Likert scale, 1 to 4.
Measured: Baseline; 6 weeks (post-intervention); 12 and 18 month follow-up.
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.
Measured: Baseline; 6 weeks (post-intervention); 12 and 18 month follow-up.
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.
Measured: Baseline; 6 weeks (post-intervention); 12 and 18 month follow-up.
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.
Measured: Baseline; 6 weeks (post-intervention); 12 and 18 month follow-up.
Secondary outcomes (7)
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.
Measured: Baseline; 6 weeks (post-intervention); 12 and 18 month follow-up.
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.
Measured: Baseline; 6 weeks (post-intervention); 12 and 18 month follow-up.
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.
Measured: Baseline; 6 weeks (post-intervention); 12 and 18 month follow-up.
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.
Measured: Baseline; 6 weeks (post-intervention); 12 and 18 month follow-up.
Change in Emotional Regulation: Decentering
The Experiences Questionnaire is a 12 item instrument that assesses decentering. 5-point Likert scale,1 to 5.
Measured: Baseline; 6 weeks (post-intervention); 12 and 18 month follow-up.
Change in Cognitive Function
Outcome contains:
- 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.
- 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.
Measured: Baseline; 6 weeks (post-intervention); 12 and 18 month follow-up.
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.
Measured: Baseline; 6 weeks (post-intervention); 12 and 18 month follow-up.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 May 2018
- Study start9 Jul 2018
- Primary completion1 Dec 2020
- Study completion1 Dec 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (21)Papers the sponsor has linked to this study.
- Other trials for Burnout, ProfessionalStudies of the same condition, open and under way.
- More trials run by University of California, San FranciscoThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 48 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of California, San Francisco
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Carter C Lebares, MD, Principal investigator, University of California, San Francisco
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03516877
- Sponsor's protocol ID
- 18-24596
- Acronym
- ESRT-Faculty
- Status last verified
- Oct 2021
- First submitted
- 6 Apr 2018
- Last updated
- 26 Oct 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Shanafelt TD, Hasan O, Dyrbye LN, Sinsky C, Satele D, Sloan J, West CP. Changes in Burnout and Satisfaction With Work-Life Balance in Physicians and the General US Working Population Between 2011 and 2014. Mayo Clin Proc. 2015 Dec;90(12):1600-13. doi: 10.1016/j.mayocp.2015.08.023.
PubMed 26653297Shanafelt TD, Balch CM, Bechamps G, Russell T, Dyrbye L, Satele D, Collicott P, Novotny PJ, Sloan J, Freischlag J. Burnout and medical errors among American surgeons. Ann Surg. 2010 Jun;251(6):995-1000. doi: 10.1097/SLA.0b013e3181bfdab3.
PubMed 19934755Scheepers RA, Boerebach BC, Arah OA, Heineman MJ, Lombarts KM. A Systematic Review of the Impact of Physicians' Occupational Well-Being on the Quality of Patient Care. Int J Behav Med. 2015 Dec;22(6):683-98. doi: 10.1007/s12529-015-9473-3.
PubMed 25733349Haas JS, Cook EF, Puopolo AL, Burstin HR, Cleary PD, Brennan TA. Is the professional satisfaction of general internists associated with patient satisfaction? J Gen Intern Med. 2000 Feb;15(2):122-8. doi: 10.1046/j.1525-1497.2000.02219.x.
PubMed 10672116DiMatteo MR, Sherbourne CD, Hays RD, Ordway L, Kravitz RL, McGlynn EA, Kaplan S, Rogers WH. Physicians' characteristics influence patients' adherence to medical treatment: results from the Medical Outcomes Study. Health Psychol. 1993 Mar;12(2):93-102. doi: 10.1037/0278-6133.12.2.93.
PubMed 8500445Del Canale S, Louis DZ, Maio V, Wang X, Rossi G, Hojat M, Gonnella JS. The relationship between physician empathy and disease complications: an empirical study of primary care physicians and their diabetic patients in Parma, Italy. Acad Med. 2012 Sep;87(9):1243-9. doi: 10.1097/ACM.0b013e3182628fbf.
PubMed 22836852Sinsky CA, Dyrbye LN, West CP, Satele D, Tutty M, Shanafelt TD. Professional Satisfaction and the Career Plans of US Physicians. Mayo Clin Proc. 2017 Nov;92(11):1625-1635. doi: 10.1016/j.mayocp.2017.08.017. Epub 2017 Nov 1.
PubMed 29101932Dyrbye LN, Trockel M, Frank E, Olson K, Linzer M, Lemaire J, Swensen S, Shanafelt T, Sinsky CA. Development of a Research Agenda to Identify Evidence-Based Strategies to Improve Physician Wellness and Reduce Burnout. Ann Intern Med. 2017 May 16;166(10):743-744. doi: 10.7326/M16-2956. Epub 2017 Apr 18. No abstract available.
PubMed 28418518Bodenheimer T, Sinsky C. From triple to quadruple aim: care of the patient requires care of the provider. Ann Fam Med. 2014 Nov-Dec;12(6):573-6. doi: 10.1370/afm.1713.
PubMed 25384822Campbell J, Prochazka AV, Yamashita T, Gopal R. Predictors of persistent burnout in internal medicine residents: a prospective cohort study. Acad Med. 2010 Oct;85(10):1630-4. doi: 10.1097/ACM.0b013e3181f0c4e7.
PubMed 20881685Center C, Davis M, Detre T, Ford DE, Hansbrough W, Hendin H, Laszlo J, Litts DA, Mann J, Mansky PA, Michels R, Miles SH, Proujansky R, Reynolds CF 3rd, Silverman MM. Confronting depression and suicide in physicians: a consensus statement. JAMA. 2003 Jun 18;289(23):3161-6. doi: 10.1001/jama.289.23.3161.
PubMed 12813122Karlamangla AS, Singer BH, McEwen BS, Rowe JW, Seeman TE. Allostatic load as a predictor of functional decline. MacArthur studies of successful aging. J Clin Epidemiol. 2002 Jul;55(7):696-710. doi: 10.1016/s0895-4356(02)00399-2.
PubMed 12160918Arora S, Sevdalis N, Aggarwal R, Sirimanna P, Darzi A, Kneebone R. Stress impairs psychomotor performance in novice laparoscopic surgeons. Surg Endosc. 2010 Oct;24(10):2588-93. doi: 10.1007/s00464-010-1013-2. Epub 2010 Mar 31.
PubMed 20354878Wetzel CM, Kneebone RL, Woloshynowych M, Nestel D, Moorthy K, Kidd J, Darzi A. The effects of stress on surgical performance. Am J Surg. 2006 Jan;191(1):5-10. doi: 10.1016/j.amjsurg.2005.08.034.
PubMed 16399098Jha AP, Stanley EA, Kiyonaga A, Wong L, Gelfand L. Examining the protective effects of mindfulness training on working memory capacity and affective experience. Emotion. 2010 Feb;10(1):54-64. doi: 10.1037/a0018438.
PubMed 20141302
Study at a glance
From the registry record, last updated by the sponsor on 26 Oct 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Enhanced Stress Resilience Training for Faculty Physicians
- ClinicalTrials.gov ID
- NCT03516877
- Acronym / sponsor ID
- ESRT-Faculty / 18-24596
- Conditions
- Burnout, Professional
- Keywords
- Mindfulness-Bases Stress Reduction, Stress, Resilience, Well-being
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 48 participants (actual)
- Lead sponsor
- University of California, San FranciscoUniversity, hospital or other
- Study start
- 9 Jul 2018 (actual)
- Primary completion
- 1 Dec 2020 (actual)
- Study completion
- 1 Dec 2020 (actual)
- First posted
- 4 May 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| ESRT | Experimental | Behavioral: Enhanced Stress Resilience Training for Faculty PhysiciansVolunteer 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. |
Who may qualify
- Ages
- 18 to 64 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (1 listed)
- Any consented surgery or anesthesia faculty who does not meet exclusion criteria.
Key exclusion criteria (1 listed)
- Lifetime history of an organic mental illness.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Enhanced Stress Resilience Training for Faculty PhysiciansAlso: ESRTEnhanced 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. | Behavioural | ESRT |
Primary outcome
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.
7 secondary outcomes
Change in Performance: Strategies
Time frame: Baseline; 6 weeks (post-intervention); 12 and 18 month follow-up.
Change in Performance: Psychological Skills
Time frame: Baseline; 6 weeks (post-intervention); 12 and 18 month follow-up.
Change in Emotional Regulation: Mind-Wandering
Time frame: Baseline; 6 weeks (post-intervention); 12 and 18 month follow-up.
Change in Emotional Regulation: Emotions
Time frame: Baseline; 6 weeks (post-intervention); 12 and 18 month follow-up.
Change in Emotional Regulation: Decentering
Time frame: Baseline; 6 weeks (post-intervention); 12 and 18 month follow-up.
Change in Cognitive Function
Time frame: Baseline; 6 weeks (post-intervention); 12 and 18 month follow-up.
Change in Cognitive Function: NIH EXAMINER Battery
Time frame: Baseline; 6 weeks (post-intervention); 12 and 18 month follow-up.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Oct 2021.
- Results publication: PubMed 26653297Shanafelt TD, Hasan O, Dyrbye LN, Sinsky C, Satele D, Sloan J, West CP. Changes in Burnout and Satisfaction With Work-Life Balance in Physicians and the General US Working Population Between 2011 and 2014. Mayo Clin Proc. 2015 Dec;90(12):1600-13. doi: 10.1016/j.mayocp.2015.08.023.
- Results publication: PubMed 19934755Shanafelt TD, Balch CM, Bechamps G, Russell T, Dyrbye L, Satele D, Collicott P, Novotny PJ, Sloan J, Freischlag J. Burnout and medical errors among American surgeons. Ann Surg. 2010 Jun;251(6):995-1000. doi: 10.1097/SLA.0b013e3181bfdab3.
- Results publication: PubMed 25733349Scheepers RA, Boerebach BC, Arah OA, Heineman MJ, Lombarts KM. A Systematic Review of the Impact of Physicians' Occupational Well-Being on the Quality of Patient Care. Int J Behav Med. 2015 Dec;22(6):683-98. doi: 10.1007/s12529-015-9473-3.
- Results publication: PubMed 10672116Haas JS, Cook EF, Puopolo AL, Burstin HR, Cleary PD, Brennan TA. Is the professional satisfaction of general internists associated with patient satisfaction? J Gen Intern Med. 2000 Feb;15(2):122-8. doi: 10.1046/j.1525-1497.2000.02219.x.
- Results publication: PubMed 8500445DiMatteo MR, Sherbourne CD, Hays RD, Ordway L, Kravitz RL, McGlynn EA, Kaplan S, Rogers WH. Physicians' characteristics influence patients' adherence to medical treatment: results from the Medical Outcomes Study. Health Psychol. 1993 Mar;12(2):93-102. doi: 10.1037/0278-6133.12.2.93.
- Results publication: PubMed 22836852Del Canale S, Louis DZ, Maio V, Wang X, Rossi G, Hojat M, Gonnella JS. The relationship between physician empathy and disease complications: an empirical study of primary care physicians and their diabetic patients in Parma, Italy. Acad Med. 2012 Sep;87(9):1243-9. doi: 10.1097/ACM.0b013e3182628fbf.
- Results publication: PubMed 29101932Sinsky CA, Dyrbye LN, West CP, Satele D, Tutty M, Shanafelt TD. Professional Satisfaction and the Career Plans of US Physicians. Mayo Clin Proc. 2017 Nov;92(11):1625-1635. doi: 10.1016/j.mayocp.2017.08.017. Epub 2017 Nov 1.
- Results publication: PubMed 28418518Dyrbye LN, Trockel M, Frank E, Olson K, Linzer M, Lemaire J, Swensen S, Shanafelt T, Sinsky CA. Development of a Research Agenda to Identify Evidence-Based Strategies to Improve Physician Wellness and Reduce Burnout. Ann Intern Med. 2017 May 16;166(10):743-744. doi: 10.7326/M16-2956. Epub 2017 Apr 18. No abstract available.
- Results publication: PubMed 25384822Bodenheimer T, Sinsky C. From triple to quadruple aim: care of the patient requires care of the provider. Ann Fam Med. 2014 Nov-Dec;12(6):573-6. doi: 10.1370/afm.1713.
- Results publication: PubMed 20881685Campbell J, Prochazka AV, Yamashita T, Gopal R. Predictors of persistent burnout in internal medicine residents: a prospective cohort study. Acad Med. 2010 Oct;85(10):1630-4. doi: 10.1097/ACM.0b013e3181f0c4e7.
- Results publication: PubMed 12813122Center C, Davis M, Detre T, Ford DE, Hansbrough W, Hendin H, Laszlo J, Litts DA, Mann J, Mansky PA, Michels R, Miles SH, Proujansky R, Reynolds CF 3rd, Silverman MM. Confronting depression and suicide in physicians: a consensus statement. JAMA. 2003 Jun 18;289(23):3161-6. doi: 10.1001/jama.289.23.3161.
- Results publication: PubMed 12160918Karlamangla AS, Singer BH, McEwen BS, Rowe JW, Seeman TE. Allostatic load as a predictor of functional decline. MacArthur studies of successful aging. J Clin Epidemiol. 2002 Jul;55(7):696-710. doi: 10.1016/s0895-4356(02)00399-2.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Carter C Lebares, MD principal investigator
University of California, San Francisco
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Enhanced Stress Resilience Training for Faculty Physicians in people with Burnout, Professional, run by University of California, San Francisco at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 26 Oct 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in Psychological Well-being: Burnout (time frame: Baseline; 6 weeks (post-intervention); 12 and 18 month follow-up.). The study lists 10 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03516877, which also lists 21 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 26 Oct 2021.