Mindful Mental Training for Surgeons to Enhance Resilience and Performance Under Stress

NCT03141190 | Completed DMC

• 1 other identifier: 16-19688
• Study Type: interventional
• Target: 44
• Locations: 1 country
• Sites: 1

Brief Summary

Background: Burnout and overwhelming stress are growing issues among surgeons and are associated with mental illness, attrition and diminished patient care. Among surgical trainees, burnout and distress are alarmingly prevalent but high inherent mindfulness has been shown to decrease the risk of depression, suicidal ideation, burnout and overwhelming stress by more than 75%. In other high-stress populations formal mindfulness training has been shown to improve mental health and buffer overwhelming stress and yet this approach has not been tried in surgery. The aim of this study is to evaluate feasibility and acceptability of modified mindfulness-based stress reduction (MBSR) training among PGY-1 surgery residents and to obtain initial evidence of efficacy in regard to well-being and performance. Design: A pilot randomized clinical trial of modified MBSR versus an active control. Setting: Residency training program, tertiary academic medical center. Participants: PGY-1 surgery residents. Intervention: Weekly two-hour modified MBSR classes (compared to an active control) and 20 minutes of suggested daily home practice over an eight-week period. Main Outcomes and Measures: Primary outcome is feasibility, assessed along six domains (demand, implementation, practicality, acceptability, adaptation and integration), using focus groups, interviews, surveys, attendance, daily practice time and subjective self-report of experience. Secondary outcomes include perceived stress, mindfulness and executive function (specifically working memory capacity), followed by psychosocial well-being (burnout, depression, resilience), performance (motor skills testing) and functional brain scans focused on areas associated with reappraisal as a surrogate for emotional control. This study seeks to demonstrate the feasibility of mindfulness training in surgery PGY-1s while simultaneously providing preliminary quantitative data on the effects of mindfulness training in a randomized, controlled setting. Data will inform modifications to the MBSR curriculum that enhance feasibility and inform sample size calculations for subsequent, adequately-powered RCTs which will likely need to be multi-center trials. Results could potentially impact formal medical training, the mental health of providers at every level, and the overall quality of patient care.

Conditions

Burnout Syndrome; Surgery; Stress

Keywords

stress, surgery, mindfulness, feasibility

Outcome Measures

Primary Outcomes (1)

• Change in Stress

  Cohen's Perceived Stress Scale (PSS)

  baseline, 8wks (post-intervention),12-month follow-up

Secondary Outcomes (1)

• Change in Executive Function

  baseline, 8wks (post-intervention),12-month follow-up

Other Outcomes (3)

• Change in Motor skills

  baseline, 8wks (post-intervention),12-month follow-up

• Change in Functional neuroanatomic changes

  baseline, 8wks (post-intervention),12-month follow-up

• Change in Psychological well-being

  baseline, 8wks (post-intervention),12-month follow-up

Study Arms (2)

Mental Training for Surgeons

EXPERIMENTAL

Mindfulness-Based Stress Reduction (MBSR, as published elsewhere extensively) slightly modified by shortening the eight weekly classes to 2 hours each and the home practice requirement to 20 minutes. Taught by a veteran MBSR teacher with greater than 10,000 hours of personal practice and nearly 10 years of formal MBSR teaching experience.

Behavioral: Mindfulness Based Stress Reduction - modified

The Mind of a Surgeon

ACTIVE COMPARATOR

8 weekly classes of 2 hours each with group reading and discussion of selected articles and stories about the ethos and experience of becoming a surgeon. Designed and administered by a surgical faculty member with extensive experience in surgical education and scholarly work in the area of the 'surgical personality'.

Behavioral: Active listening and reading

Interventions

Mindfulness Based Stress Reduction - modified BEHAVIORAL

already described

Also known as: MBSR

Mental Training for Surgeons

Active listening and reading BEHAVIORAL

group reading, listening and discussion of articles pertaining to the development and experience of the surgical personality

The Mind of a Surgeon

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may not qualify if:

• Current personal mindfulness practice, medications with CNS effects, lifetime history of a mental disorder, acute or chronic immune or inflammatory disorders, pregnancy, breast-feeding or implanted MRI-incompatible metal.

Sponsors & Collaborators

• University of California, San Francisco: lead

Study Sites (1)

University of California San Francisco

San Francisco, California, 94143, United States

Location

Related Publications (25)

• 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.

  PMID: 26653297 BACKGROUND

• 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.

  PMID: 19934755 BACKGROUND

• 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.

  PMID: 25733349 BACKGROUND

• 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.

  PMID: 10672116 BACKGROUND

• 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.

  PMID: 8500445 BACKGROUND

• 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.

  PMID: 22836852 BACKGROUND

• 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.

  PMID: 29101932 BACKGROUND

• 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.

  PMID: 28418518 BACKGROUND

• 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.

  PMID: 25384822 BACKGROUND

• 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.

  PMID: 20881685 BACKGROUND

• 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.

  PMID: 12813122 BACKGROUND

• 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.

  PMID: 12160918 BACKGROUND

• 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.

  PMID: 20354878 BACKGROUND

• 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.

  PMID: 16399098 BACKGROUND

• 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.

  PMID: 20141302 BACKGROUND

• 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.

  PMID: 25158633 BACKGROUND

• 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.

  PMID: 26953856 BACKGROUND

• 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.

  PMID: 24832476 BACKGROUND

• 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.

  PMID: 29107117 BACKGROUND

• 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.

  PMID: 18817740 BACKGROUND

• 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.

  PMID: 19773563 BACKGROUND

• Lebares CC, Coaston TN, Delucchi KL, Guvva EV, Shen WT, Staffaroni AM, Kramer JH, Epel ES, Hecht FM, Ascher NL, Harris HW, Cole SW. Enhanced Stress Resilience Training in Surgeons: Iterative Adaptation and Biopsychosocial Effects in 2 Small Randomized Trials. Ann Surg. 2021 Mar 1;273(3):424-432. doi: 10.1097/SLA.0000000000004145.

  PMID: 32773637 RESULT

• Lebares CC, Hershberger AO, Guvva EV, Desai A, Mitchell J, Shen W, Reilly LM, Delucchi KL, O'Sullivan PS, Ascher NL, Harris HW. Feasibility of Formal Mindfulness-Based Stress-Resilience Training Among Surgery Interns: A Randomized Clinical Trial. JAMA Surg. 2018 Oct 1;153(10):e182734. doi: 10.1001/jamasurg.2018.2734. Epub 2018 Oct 17.

  PMID: 30167655 RESULT

• Lebares CC, Guvva EV, Olaru M, Sugrue LP, Staffaroni AM, Delucchi KL, Kramer JH, Ascher NL, Harris HW. Efficacy of Mindfulness-Based Cognitive Training in Surgery: Additional Analysis of the Mindful Surgeon Pilot Randomized Clinical Trial. JAMA Netw Open. 2019 May 3;2(5):e194108. doi: 10.1001/jamanetworkopen.2019.4108.

  PMID: 31125095 RESULT

• Kunzler AM, Helmreich I, Chmitorz A, Konig J, Binder H, Wessa M, Lieb K. Psychological interventions to foster resilience in healthcare professionals. Cochrane Database Syst Rev. 2020 Jul 5;7(7):CD012527. doi: 10.1002/14651858.CD012527.pub2.

  PMID: 32627860 DERIVED

MeSH Terms

Conditions

Burnout, Psychological

Condition Hierarchy (Ancestors)

Stress, Psychological; Behavioral Symptoms; Behavior

Study Officials

• Carter Lebares, MD

  University of California, San Francisco

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Masking Details: Participants do not know we are testing mindfulness only that they will be learning stress-reduction skills for surgeons
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Randomized, partially-blinded

Study Record Dates

• First Submitted: May 1, 2017
• First Posted: May 5, 2017
• Study Start: June 1, 2017
• Primary Completion: June 30, 2018
• Study Completion: June 30, 2018
• Last Updated: March 22, 2022

Record last verified: 2022-03

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)