NCT03516877

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
48

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Jul 2018

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

April 6, 2018

Completed
28 days until next milestone

First Posted

Study publicly available on registry

May 4, 2018

Completed
2 months until next milestone

Study Start

First participant enrolled

July 9, 2018

Completed
2.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2020

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2020

Completed
Last Updated

October 26, 2021

Status Verified

October 1, 2021

Enrollment Period

2.4 years

First QC Date

April 6, 2018

Last Update Submit

October 25, 2021

Conditions

Keywords

Mindfulness-Bases Stress Reduction, Stress, Resilience, Well-being

Outcome Measures

Primary Outcomes (10)

  • 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.

    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.

    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.

    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.

    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.

    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.

    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.

    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.

    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.

    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.

    Baseline; 6 weeks (post-intervention); 12 and 18 month follow-up.

Secondary Outcomes (7)

  • Change in Performance: Strategies

    Baseline; 6 weeks (post-intervention); 12 and 18 month follow-up.

  • Change in Performance: Psychological Skills

    Baseline; 6 weeks (post-intervention); 12 and 18 month follow-up.

  • Change in Emotional Regulation: Mind-Wandering

    Baseline; 6 weeks (post-intervention); 12 and 18 month follow-up.

  • Change in Emotional Regulation: Emotions

    Baseline; 6 weeks (post-intervention); 12 and 18 month follow-up.

  • Change in Emotional Regulation: Decentering

    Baseline; 6 weeks (post-intervention); 12 and 18 month follow-up.

  • +2 more secondary outcomes

Study Arms (1)

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.

Behavioral: Enhanced Stress Resilience Training for Faculty Physicians

Interventions

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.

Also known as: ESRT
ESRT

Eligibility Criteria

Age18 Years - 64 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may not qualify if:

  • \- Lifetime history of an organic mental illness.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of California San Francisco

San Francisco, California, 94143, United States

Location

Related Publications (21)

  • 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.

  • Shanafelt 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.

  • Scheepers 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.

  • Haas 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.

  • DiMatteo 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.

  • Del 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.

  • Sinsky 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.

  • Dyrbye 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.

  • Bodenheimer 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.

  • Campbell 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.

  • Center 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.

  • Karlamangla 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.

  • Arora 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.

  • Wetzel 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.

  • Jha 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.

  • Seppala EM, Nitschke JB, Tudorascu DL, Hayes A, Goldstein MR, Nguyen DT, Perlman D, Davidson RJ. Breathing-based meditation decreases posttraumatic stress disorder symptoms in U.S. military veterans: a randomized controlled longitudinal study. J Trauma Stress. 2014 Aug;27(4):397-405. doi: 10.1002/jts.21936.

  • Amutio A, Martinez-Taboada C, Delgado LC, Hermosilla D, Mozaz MJ. Acceptability and Effectiveness of a Long-Term Educational Intervention to Reduce Physicians' Stress-Related Conditions. J Contin Educ Health Prof. 2015 Fall;35(4):255-60. doi: 10.1097/CEH.0000000000000002.

  • Johnson DC, Thom NJ, Stanley EA, Haase L, Simmons AN, Shih PA, Thompson WK, Potterat EG, Minor TR, Paulus MP. Modifying resilience mechanisms in at-risk individuals: a controlled study of mindfulness training in Marines preparing for deployment. Am J Psychiatry. 2014 Aug;171(8):844-53. doi: 10.1176/appi.ajp.2014.13040502.

  • Lebares CC, Guvva EV, Ascher NL, O'Sullivan PS, Harris HW, Epel ES. Burnout and Stress Among US Surgery Residents: Psychological Distress and Resilience. J Am Coll Surg. 2018 Jan;226(1):80-90. doi: 10.1016/j.jamcollsurg.2017.10.010. Epub 2017 Oct 26.

  • Wager TD, Davidson ML, Hughes BL, Lindquist MA, Ochsner KN. Prefrontal-subcortical pathways mediating successful emotion regulation. Neuron. 2008 Sep 25;59(6):1037-50. doi: 10.1016/j.neuron.2008.09.006.

  • Krasner MS, Epstein RM, Beckman H, Suchman AL, Chapman B, Mooney CJ, Quill TE. Association of an educational program in mindful communication with burnout, empathy, and attitudes among primary care physicians. JAMA. 2009 Sep 23;302(12):1284-93. doi: 10.1001/jama.2009.1384.

MeSH Terms

Conditions

Burnout, Professional

Condition Hierarchy (Ancestors)

Occupational StressOccupational DiseasesBurnout, PsychologicalStress, PsychologicalBehavioral SymptomsBehavior

Study Officials

  • Carter C Lebares, MD

    University of California, San Francisco

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

April 6, 2018

First Posted

May 4, 2018

Study Start

July 9, 2018

Primary Completion

December 1, 2020

Study Completion

December 1, 2020

Last Updated

October 26, 2021

Record last verified: 2021-10

Data Sharing

IPD Sharing
Will not share

Locations