Working...
ClinicalTrials.gov
ClinicalTrials.gov Menu

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT03141190
Recruitment Status : Completed
First Posted : May 5, 2017
Last Update Posted : October 2, 2018
Sponsor:
Information provided by (Responsible Party):
Carter Lebares, University of California, San Francisco

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.


Condition or disease Intervention/treatment Phase
Burnout Syndrome Surgery Stress Behavioral: Mindfulness Based Stress Reduction - modified Behavioral: Active listening and reading Not Applicable

  Show Detailed Description

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 21 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: Randomized, partially-blinded
Masking: Double (Participant, Outcomes Assessor)
Masking Description: Participants do not know we are testing mindfulness only that they will be learning stress-reduction skills for surgeons
Primary Purpose: Prevention
Official Title: Mindfulness Training to Improve Mental Health, Stress and Performance In Physicians
Actual Study Start Date : June 2016
Actual Primary Completion Date : December 31, 2017
Actual Study Completion Date : December 31, 2017

Arm Intervention/treatment
Experimental: Mental Training for Surgeons
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
already described
Other Name: MBSR

Active Comparator: The Mind of a Surgeon
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
group reading, listening and discussion of articles pertaining to the development and experience of the surgical personality




Primary Outcome Measures :
  1. Change in Stress [ Time Frame: baseline, 8wks (post-intervention),12-month follow-up ]
    Cohen's Perceived Stress Scale (PSS)


Secondary Outcome Measures :
  1. Change in Executive Function [ Time Frame: baseline, 8wks (post-intervention),12-month follow-up ]
    Executive function as assessed via working memory capacity, cognitive control and executive composite components of the NIH EXAMINER battery.

  2. Change in Psychological well-being [ Time Frame: baseline, 8wks (post-intervention),12-month follow-up ]
    burnout (Maslach burnout inventory), depression (PHQ-9), resilience (ER89), Grit (GRIT-S), mindfulness (CAMS-R)


Other Outcome Measures:
  1. Change in Motor skills [ Time Frame: baseline, 8wks (post-intervention),12-month follow-up ]
    Performance as assessed by the Fundamentals of Laparoscopic Surgery (FLS) modules

  2. Change in Functional neuroanatomic changes [ Time Frame: baseline, 8wks (post-intervention),12-month follow-up ]
    Functional changes in areas associated with reappraisal/emotional regulation (amygdala, hippocampus, reward circuitry, appraisal pathway) as evidenced by fMRI BOLD and DTI brain scans analyzed by whole brain and a prior region of interest approaches.



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • UCSF surgical interns entering training. Do not meet exclusion criteria.

Exclusion Criteria:

  • 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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03141190


Locations
Layout table for location information
United States, California
University of California San Francisco
San Francisco, California, United States, 94143
Sponsors and Collaborators
University of California, San Francisco
Investigators
Layout table for investigator information
Principal Investigator: Carter Lebares, MD University of California, San Francisco

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Layout table for additonal information
Responsible Party: Carter Lebares, Assistant Professor of Surgery In Residence, University of California, San Francisco
ClinicalTrials.gov Identifier: NCT03141190     History of Changes
Other Study ID Numbers: 16-19688
First Posted: May 5, 2017    Key Record Dates
Last Update Posted: October 2, 2018
Last Verified: September 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Layout table for additional information
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Carter Lebares, University of California, San Francisco:
stress, surgery, mindfulness, feasibility

Additional relevant MeSH terms:
Layout table for MeSH terms
Burnout, Psychological
Stress, Psychological
Behavioral Symptoms