Enhanced Stress Resilience Training for Residents

NCT03518359 | Completed

• 1 other identifier: 18-24601
• Study Type: interventional
• Target: 45
• Locations: 1 country
• Sites: 1

Brief Summary

Burnout and overwhelming stress are growing issues in medicine and are associated with mental illness, performance deficits and diminished patient care. Among surgical trainees, high dispositional mindfulness decreases these risks by 75% or more, and formal mindfulness training has been shown feasible and acceptable. In other high-stress populations formal mindfulness training has improved well-being, stress, cognition and performance, yet the ability of such training to mitigate stress and burnout across medical specialties, or to affect improvements in the cognition and performance of physicians, remains unknown. To address these gaps and thereby promote the wider adoption of contemplative practices within medical training, investigators have developed Enhanced Stress Resilience Training, a modified form of MBSR - streamlined, tailored and contextualized for physicians and trainees. Investigators propose to test Enhanced Stress Resilience Training (ESRT), versus active control and residency-as-usual, in surgical and non-surgical residents evaluated for well-being, cognition and performance changes at baseline, post-intervention and six-month follow-up.

Conditions

Stress; Mindfulness; Cognitive Change

Keywords

Residents; Stress; Well-being

Outcome Measures

Primary Outcomes (1)

• Change in executive function: National Institutes of Health Examiner battery

  Executive function as assessed via working memory capacity, cognitive control and executive composite components of the 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.

  Baseline; post-intervention (9-10wk after baseline), 6 months follow-up.

Secondary Outcomes (7)

• Change in psychological well-being: Mental Health Continuum

  Baseline; post-intervention (9-10wk after baseline), 6 months follow-up.

• Change in psychological well-being: Perceived Stress

  Baseline; post-intervention (9-10wk after baseline), 6 months follow-up.

• Change in psychological well-being: Burnout

  Baseline; post-intervention (9-10wk after baseline), 6 months follow-up.

• Change in psychological well-being: Anxiety

  Baseline; post-intervention (9-10wk after baseline), 6 months follow-up.

• Change in psychological well-being: Depression

  Baseline; post-intervention (9-10wk after baseline), 6 months follow-up.

Other Outcomes (6)

• Functional neuroanatomic changes

  Baseline; post-intervention (9-10wk after baseline), 6 months follow-up.

• Motor skills

  Baseline; 6 weeks post-intervention (9-10wk after baseline), 6 months follow-up.

• Mind-Wandering

  Baseline; post-intervention (9-10wk after baseline), 6 months follow-up.

Study Arms (2)

Mental Training for Residents

EXPERIMENTAL

The intervention will be the modified form of Mindfulness-Based Stress Reduction (MBSR). For this study investigator named the experimental arm Enhanced Stress Resilience Training (ESRT).

Behavioral: Enhanced Stress Resilience Training (ESRT)

Active Control

ACTIVE COMPARATOR

Active control that emphasizes externalized attention via the "shared reading and listening" model.

Behavioral: Active Control

Interventions

Enhanced Stress Resilience Training (ESRT) BEHAVIORAL

ESRT involves six weekly 90-minute group classes and one 2 - 4 hour retreat. Classes focus on developing mindfulness skills (i.e. sustained attention, open monitoring, emotional regulation, meta-cognition) in the context of skills and concepts for managing stress, particularly in practicing medicine. Homework consists of 20 minutes per day of mindfulness exercises following guided meditation CDs or videos of movement-based practice, and practice will be reported periodically by text. A 3-hour outdoor retreat occurs at week six. The central exercises of ESRT are the body scan, sitting meditation, chi gong and yoga. For both arms, the weekly teaching sessions occur on a workday morning during protected time at Parnassus, Mission Bay or Zuckerberg San Francisco General Hospital campus.

Also known as: Modified MBSR

Mental Training for Residents

Active Control BEHAVIORAL

Control group participants will meet for 6 weeks, 90 minutes each week, for classes focuses on stress management through rest and exercise, with equivalent protected time and small group bonding but without the use of contemplative practices. Topics will include the history of surgery, patient perspective, the physician personality, technical mastery, fallibility and limits, balancing compassion and detachment and knowing when not to operate. For daily practice, control participants will be asked to devote 20 min per day to stress management through rest and exercise again reported daily by text.

Active Control

Eligibility Criteria

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

You may qualify if:

• Any consented medical intern from Emergency Medecine, Internal Medicine, Pediatrics, Family Practice, OBGYN and Surgery Depratments in-coming to University of California San Francisco in the study year.

You may not qualify if:

• Current personal mindfulness practice, once a week or more frequent;
• Use of medications with Central Nervous System effects;
• Lifetime history of an organic mental illness;
• Acute or chronic immune or inflammatory disorders;
• Pregnancy;

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 (24)

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• 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.

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• 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

• 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 DERIVED

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  PMID: 32627860 DERIVED

Study Officials

• Carter K Lebrares, 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 that the investigator is testing mindfulness. Participants only will be told that they will be learning stress-reduction skills for physicians.
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Randomized, partially-blinded.

Study Record Dates

• First Submitted: April 24, 2018
• First Posted: May 8, 2018
• Study Start: June 13, 2018
• Primary Completion: June 30, 2021
• Study Completion: June 30, 2021
• Last Updated: February 24, 2022

Record last verified: 2022-02

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)