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Recruiting NCT07707453

The COMET Study: a Prospective COhort of MEdical residenTs to Assess Professional, Personal and Psychological Trajectories of Residents in General Internal Medicine

Observational Burnout Syndrome Depression Disorder Insomnia Perceived Stress

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
This is an observational study: the protocol does not assign a study treatment.
Who it may be relevant to
Registry conditions: Burnout Syndrome, Depression Disorder, Insomnia, Perceived Stress. Basic parameters: No limits · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Switzerland
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Overview

Introduction. Switzerland, like most Western countries, faces a paradox: an ageing, multimorbid population needs general internal medicine (GIM) physicians more than ever, yet fewer young doctors choose - and stay in - the specialty. Career decisions during residency are intertwined with well-being, mental and physical health, and work-life balance, and distress in training has been associated with depression, burnout, attrition and poorer patient care. Longitudinal data following GIM residents across these domains, and linking them to actual career trajectories, are lacking. The COMET study establishes a multicentre prospective cohort of GIM residents to fill this gap. Methods and analysis. COMET is a prospective, open, multicentre cohort conducted in the departments of (general) internal medicine of Fribourg Hospital (HFR, four sites), Bern University Hospital (Inselspital) and Lausanne University Hospital (CHUV). All GIM residents providing direct patient care are eligible (≈334 residents; expected enrolment ≥267, assuming 80% participation). Participants complete an annual online survey (REDCap; French or German) at baseline and for at least four years, covering sociodemographics; job characteristics; career intentions and 24 factors for or against a GIM career; well-being (Physician Well-Being Index, Professional Fulfillment Index, quality of life, work-life balance); mental health (CES-D, Perceived Stress Scale, Maslach Burnout Inventory, Questionnaire of Cognitive and Affective Empathy); and physical health (step counts, physical activity, fatigue, sleep, healthcare utilisation). Primary endpoints are the longitudinal course of well-being and distress (PWBI, PFI, CES-D) and residents' career trajectory. Analyses combine descriptive statistics, mixed-effects and regression models, and comparisons with the population-based CoLaus\|PsyCoLaus cohort.

Primary outcome measures

  • Change from baseline in psychological distress measured by the Physician Well-Being Index (PWBI) [Time frame: Baseline and annually at years 1, 2, 3, 4 and 5]
  • Change from baseline in professional fulfilment measured by the Professional Fulfillment Index (PFI) - professional fulfilment subscale [Time frame: Baseline and annually at years 1, 2, 3, 4 and 5]
  • Change from baseline in burnout measured by the Professional Fulfillment Index (PFI) - burnout composite [Time frame: Baseline and annually at years 1, 2, 3, 4 and 5]
  • Change from baseline in depressive symptoms measured by the Center for Epidemiologic Studies-Depression scale (CES-D) [Time frame: Baseline and annually at years 1, 2, 3, 4 and 5]
  • Percentage of participants remaining in general internal medicine training or practice [Time frame: Annually at years 1, 2, 3, 4 and 5]
  • Intention to leave direct patient care, measured on a single-item 5-point scale [Time frame: Baseline and annually at years 1, 2, 3, 4 and 5]
Secondary outcome measures (12)
  • Change from baseline in self-rated work-life balance (single-item 5-point scale) [Time frame: Baseline and annually at years 1, 2, 3, 4 and 5]
  • Change from baseline in perceived stress measured by the Perceived Stress Scale (PSS-10) [Time frame: Baseline and annually at years 1, 2, 3, 4 and 5]
  • Change from baseline in work exhaustion measured by the Professional Fulfillment Index (PFI) - work-exhaustion subscale [Time frame: Baseline and annually at years 1, 2, 3, 4 and 5]
  • Change from baseline in interpersonal disengagement measured by the Professional Fulfillment Index (PFI) - interpersonal-disengagement subscale [Time frame: Baseline and annually at years 1, 2, 3, 4 and 5]
  • Change from baseline in cognitive empathy measured by the Questionnaire of Cognitive and Affective Empathy (QCAE) - cognitive empathy subscale [Time frame: Baseline and annually at years 1, 2, 3, 4 and 5]
  • Change from baseline in affective empathy measured by the Questionnaire of Cognitive and Affective Empathy (QCAE) - affective empathy subscale [Time frame: Baseline and annually at years 1, 2, 3, 4 and 5]
  • Change from baseline in daily step count (smartphone-derived) [Time frame: Baseline and annually at years 1, 2, 3, 4 and 5]
  • Change from baseline in self-reported physical activity measured by the International Physical Activity Questionnaire - short form (IPAQ-SF) [Time frame: Baseline and annually at years 1, 2, 3, 4 and 5]
  • Change from baseline in fatigue measured by the Chalder Fatigue Scale [Time frame: Baseline and annually at years 1, 2, 3, 4 and 5]
  • Change from baseline in insomnia severity measured by the Insomnia Severity Index (ISI) [Time frame: Baseline and annually at years 1, 2, 3, 4 and 5]
  • Mean rating of each of 31 career pull and push factors (adapted Hauer questionnaire) [Time frame: Baseline and annually at years 1, 2, 3, 4 and 5]
  • Difference in CES-D depressive-symptom score between residents and age-matched general-population participants (CoLaus|PsyCoLaus) [Time frame: Baseline]

Eligibility criteria

Inclusion criteria

Resident physician in general internal medicine employed at a participating study site or annex centre during the recruitment period Written informed consent

Exclusion criteria

Not providing direct patient care Severe mental or physical condition precluding informed consent or compliance with the protocol

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: Yes

Study design

Observational model
Cohort

Study locations

Switzerland · 3 centers
  • Inselspital - University Hospital — Bern
  • HFR - Hôpital Cantonal — Fribourg
  • CHUV - University Hospital — Lausanne

Identifiers

NCT: NCT07707453 · CERV-VD Project-ID 2024-00444

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗