NCT03518359.

Study name	Public title: Enhanced Stress Resilience Training for Residents (ESRT‐R) Scientific title: Enhanced resilience training to improve mental health, stress and performance in resident physicians
Methods	Study design: 2‐arm RCT Study grouping: parallel assignment Unit of randomisation: individuals Power (power sample size calculation, level of power achieved): not specified Imputation of missing data: not specified
Participants	Country: USA Setting: Emergency Medicine, Internal Medicine, Paediatrics, Family Practice, Obstetrics and Gynaecology (OBGYN) and Surgery Departments of University of California San Francisco Age: see inclusion criteria; age not specified Sample size (randomised): 45 (actual enrolment) Sex: not specified Comorbidity (mean (SD) of respective measures in indicated, if available) at baseline: not specified, but participants with lifetime history of organic mental illness excluded Population description: resident physicians/medical interns Inclusion criteria: 1) any consented medical intern from Emergency Medicine, Internal Medicine, Paediatrics, Family Practice, OBGYN and Surgery Departments in‐coming to University of California San Francisco in the study year; 2) aged 18 ‐ 64 years Exclusion criteria: 1) current personal mindfulness practice, once a week or more frequent; 2) use of medications with Central Nervous System effects; 3) lifetime history of an organic mental illness; 4) acute or chronic immune or inflammatory disorders; 5) pregnancy Attrition (withdrawals and exclusions): not specified Reasons for missing data: not specified
Interventions	Intervention: Enhanced Stress Resilience Training (ESRT) (n not specified) delivery: face‐to‐face, CDs and videos; group sessions providers: not specified duration of treatment period and timing: 6 weekly 90‐minute classes (weekly teaching sessions on workday morning protected time; guided meditation CDs, videos of movement‐based practice) + single 2‐ to 4‐hour retreat + 20 minutes daily homework) description: mental training for residents 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 practising medicine DAILY HOMEWORK: mindfulness exercises following guided meditation CDs or videos of movement‐based practice (practice reported periodically by text) RETREAT: 3‐hour outdoor retreat at week 6 central exercises of ESRT: body scan, sitting meditation, chi gong, yoga compliance: not specified integrity of delivery: not specified economic information: not specified theoretical basis: modified form of MBSR Control: active control (n not specified) delivery: face‐to‐face; group sessions providers: not specified duration of treatment period and timing: 6 weekly 90‐minute classes + 20 minutes daily homework description: externalised attention via “shared reading and listening” model CLASSES: focus on stress management through rest and exercise, with equivalent protected time and small‐group bonding but without the use of contemplative practices Topics include: history of surgery, patient perspective, the physician personality, technical mastery, fallibility and limits, balancing compassion and detachment, knowing when not to operate DAILY PRACTICE: participants asked to devote 20 minutes a day to stress management through rest and exercise (reported daily by text) compliance: not specified integrity of delivery: not specified economic information: not specified theoretical basis: “shared reading and listening” model, stress management
Outcomes	Outcomes collected and reported: executive function ‐ National Institutes of Health Executive Abilities, Measures and Instruments for Neurobehavioral Evaluation and Research (NIH EXAMINER) battery psychological well‐being ‐ Mental Health Continuum perceived stress ‐ PSS burnout ‐ 2‐item MBI anxiety ‐ Spielberger’s STAI depression and suicidal ideation ‐ PHQ mindfulness ‐ CAMS‐R alcohol misuse ‐ Alcohol Use Disorder Identification Scale (Alcohol Consumption Questions) functional neuro‐anatomic changes ‐ fMRI Blood‐oxygen‐level‐dependent imaging (BOLD) and Diffusion Tensor Imaging (DTI) brain scans motor skills ‐ Fundamentals of Laparoscopic Surgery modules mind‐wandering ‐ Mind‐Wandering Questionnaire change in emotional regulation: decentring ‐ Experiences Questionnaire consultation and relational empathy ‐ Consultation and Relational Empathy Measure change in performance: patient experience ‐ Patient Enablement Instrument Outcomes reported: not specified Time points measured and reported: 1) pre‐intervention; 2) post‐intervention (9 ‐ 10 weeks after baseline); 3) 6‐month follow‐up; time points reported not specified Adverse events: not specified
Starting date	Study start/end date: June 2018; estimated primary completion date: June 2021; estimated study completion date: June 2022; active, not recruiting according to trial registration
Contact information	Principal investigator: Carter K Lebares, MD; Ekaterina V Guvva, BS Address: University of Californisa, San Francisco, California, United States, 94143 Email: carter.lebares@ucsf.edu; ekaterina.guvva@ucsf.edu Telephone: 415‐502‐5588
Notes	Contact with authors: We contacted the authors for the trial status. According to the authors, the recruitment for study is closed and the results will be published in the next 6 months (Guvva 2019 [pers comm]). Funding source: University of California, San Francisco Declaration of interest: not specified Ethical approval needed/obtained for study: not specified Comments by study authors: not specified Miscellaneous outcomes by the review authors: trial registration number: NCT03518359 (assigned 8 May 2018)