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RecruitingNCT07707453COMETUpdated Jul 16, 2026

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

An observational study in Burnout Syndrome, Depression Disorder and Insomnia, sponsored by University of Fribourg. Recruiting at 3 sites in Switzerland. Per ClinicalTrials.gov, last updated 2026-07-16.

Sponsored by University of Fribourg · Observational

From the registry’s dates

  • Started Aug 2025; still recruiting 1 year 3 months later.
Study type
Observational
Model
Cohort
Time perspective
Prospective
Enrollment
800
Sex
All
01

Study summary

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.

02

Conditions studied

  • Burnout Syndrome
  • Depression Disorder
  • Insomnia
  • Perceived Stress
  • Fatigue Symptom
  • Empathy
03

In context

Burnout, Psychological

467 studies on the registry are indexed under Burnout, Psychological; 121 are open to participants now.

This study's planned enrollment of 800 is above the median of 200 across 117 observational studies indexed under Burnout, Psychological.

Browse Burnout, Psychological studies →

Lead sponsor

University of Fribourg is the lead sponsor of 16 studies on the registry; 7 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
Child (0–17), Adult (18–64), Older adult (65+)
Sexes eligible
All
Accepts healthy volunteers
Yes
Sampling method
Non-probability sample

Study population

resident physicians in general internal medicine at approximately 22 Swiss hospital and ambulatory centres (\~1,300 eligible)

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

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

Exclusion criteria

Exclusion Criteria:

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

Terms in these criteria, in plain language(1)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

Informed consent

Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.

You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.

05

Study design

Observational model
Cohort
Time perspective
Prospective
Enrollment
800 participants (estimated)
Target follow-up
5 Years
Patient registry
Yes

Groups and cohorts

  • Residents in General Internal Medicine (GIM)

    All residents in GIM in the participating centers in Switzerland

06

What researchers measure

Primary outcomes

  1. Change from baseline in psychological distress measured by the Physician Well-Being Index (PWBI)

    The Physician Well-Being Index (resident version) comprises 7 yes/no items referring to the past month. Total score ranges from 0 to 7; higher scores indicate greater distress (worse outcome). A score of 3 or higher identifies residents at risk of distress

    Time frame: Baseline and annually at years 1, 2, 3, 4 and 5

  2. Change from baseline in professional fulfilment measured by the Professional Fulfillment Index (PFI) - professional fulfilment subscale

    The professional fulfilment subscale of the Professional Fulfillment Index comprises 6 items scored 0-4 on 5-point scales (past two weeks); the subscale score is the item mean, ranging from 0 to 4. Higher scores indicate greater professional fulfilment (better outcome); scores of 3.0 or higher indicate professional fulfilment

    Time frame: Baseline and annually at years 1, 2, 3, 4 and 5

  3. Change from baseline in burnout measured by the Professional Fulfillment Index (PFI) - burnout composite

    The burnout composite of the Professional Fulfillment Index comprises 10 items (4 work-exhaustion and 6 interpersonal-disengagement items) scored 0-4 on 5-point scales (past two weeks); the composite score is the item mean, ranging from 0 to 4. Higher scores indicate more severe burnout (worse outcome); scores of 1.33 or higher indicate burnout

    Time frame: Baseline and annually at years 1, 2, 3, 4 and 5

  4. Change from baseline in depressive symptoms measured by the Center for Epidemiologic Studies-Depression scale (CES-D)

    The Center for Epidemiologic Studies-Depression scale comprises 20 items scored 0-3 by symptom frequency over the past week. Total score ranges from 0 to 60; higher scores indicate more depressive symptoms (worse outcome). A score of 16 or higher indicates clinically relevant depressive symptoms.

    Time frame: Baseline and annually at years 1, 2, 3, 4 and 5

  5. Percentage of participants remaining in general internal medicine training or practice

    Proportion (%) of participants who, at each annual follow-up survey, report continuing postgraduate training or clinical activity in general internal medicine, versus having switched to another specialty or having left clinical medicine, assessed by structured self-report items (current work position and current specialty goal) of the annual COMET online survey

    Time frame: Annually at years 1, 2, 3, 4 and 5

  6. Intention to leave direct patient care, measured on a single-item 5-point scale

    Single self-report item of the annual COMET survey rating the likelihood of leaving direct patient care within five years, from 1 (none) to 5 (high). Higher scores indicate a stronger intention to quit (worse outcome)

    Time frame: Baseline and annually at years 1, 2, 3, 4 and 5

Secondary outcomes

  1. Change from baseline in self-rated work-life balance (single-item 5-point scale)

    Single self-report item rating the current balance between personal and professional life on a 5-point scale from 1 (very good) to 5 (very bad), as used by Keeton et al. Higher scores indicate a worse perceived work-life balance.

    Time frame: Baseline and annually at years 1, 2, 3, 4 and 5

  2. Change from baseline in perceived stress measured by the Perceived Stress Scale (PSS-10)

    The 10-item Perceived Stress Scale, referring to the past month, with items scored 0-4. Total score ranges from 0 to 40; higher scores indicate greater perceived stress (worse outcome)

    Time frame: Baseline and annually at years 1, 2, 3, 4 and 5

  3. Change from baseline in work exhaustion measured by the Professional Fulfillment Index (PFI) - work-exhaustion subscale

    The work-exhaustion subscale of the Professional Fulfillment Index comprises 4 items scored 0-4 (past two weeks); the subscale score is the item mean, ranging from 0 to 4. Higher scores indicate greater work exhaustion (worse outcome).

    Time frame: Baseline and annually at years 1, 2, 3, 4 and 5

  4. Change from baseline in interpersonal disengagement measured by the Professional Fulfillment Index (PFI) - interpersonal-disengagement subscale

    he interpersonal-disengagement subscale of the Professional Fulfillment Index comprises 6 items scored 0-4 (past two weeks); the subscale score is the item mean, ranging from 0 to 4. Higher scores indicate greater interpersonal disengagement (worse outcome)

    Time frame: Baseline and annually at years 1, 2, 3, 4 and 5

  5. Change from baseline in cognitive empathy measured by the Questionnaire of Cognitive and Affective Empathy (QCAE) - cognitive empathy subscale

    The cognitive empathy subscale of the QCAE comprises 19 items rated on 4-point agreement scales (1-4). Total score ranges from 19 to 76; higher scores indicate greater cognitive empathy (better outcome)

    Time frame: Baseline and annually at years 1, 2, 3, 4 and 5

  6. Change from baseline in affective empathy measured by the Questionnaire of Cognitive and Affective Empathy (QCAE) - affective empathy subscale

    The affective empathy subscale of the QCAE comprises 12 items rated on 4-point agreement scales (1-4). Total score ranges from 12 to 48; higher scores indicate greater affective empathy.

    Time frame: Baseline and annually at years 1, 2, 3, 4 and 5

  7. Change from baseline in daily step count (smartphone-derived)

    Average number of steps per day, reported by participants from the default health application of their smartphone as monthly averages for the current month and the two previous months (unit: steps/day). Higher values indicate more physical activity

    Time frame: Baseline and annually at years 1, 2, 3, 4 and 5

  8. Change from baseline in self-reported physical activity measured by the International Physical Activity Questionnaire - short form (IPAQ-SF)

    The IPAQ short form comprises 7 items covering vigorous activity, moderate activity, walking and sitting time over the past 7 days; responses are converted to metabolic equivalent of task (MET)-minutes per week according to the IPAQ scoring protocol. Higher values indicate more physical activity

    Time frame: Baseline and annually at years 1, 2, 3, 4 and 5

  9. Change from baseline in fatigue measured by the Chalder Fatigue Scale

    The Chalder Fatigue Scale comprises 11 items scored 0-3 (Likert scoring). Total score ranges from 0 to 33; higher scores indicate more severe fatigue (worse outcome).

    Time frame: Baseline and annually at years 1, 2, 3, 4 and 5

  10. Change from baseline in insomnia severity measured by the Insomnia Severity Index (ISI)

    The Insomnia Severity Index comprises 7 items scored 0-4, referring to sleep problems over the past two weeks. Total score ranges from 0 to 28; higher scores indicate more severe insomnia (worse outcome)

    Time frame: Baseline and annually at years 1, 2, 3, 4 and 5

  11. Mean rating of each of 31 career pull and push factors (adapted Hauer questionnaire)

    Each of 31 factors potentially influencing a career in internal medicine is rated on a 5-point bipolar scale from 1 (very pushed away) to 5 (very attracted toward), adapted from Hauer et al. Mean scores per factor (range 1-5) describe the relative weight of attracting and repelling factors; higher scores indicate a more attracting influence.

    Time frame: Baseline and annually at years 1, 2, 3, 4 and 5

  12. Difference in CES-D depressive-symptom score between residents and age-matched general-population participants (CoLaus|PsyCoLaus)

    Difference in mean Center for Epidemiologic Studies-Depression scale score (20 items, total 0-60; higher = more depressive symptoms) between COMET participants and participants aged 18-35 of the population-based CoLaus\|PsyCoLaus cohort, using the identical instrument (unit: score points)

    Time frame: Baseline

  13. Difference in QCAE empathy scores between residents and Swiss medical students

    Difference in mean QCAE cognitive (19-76) and affective (12-48) empathy subscale scores between COMET participants and published values from a national cohort of Swiss medical students, using the identical instrument (unit: score points; higher = greater empathy)

    Time frame: Baseline and year 5

07

Study locations

3 of 3 sites recruiting
08

References and documents

Study documents

PDFs hosted by the registry, ClinicalTrials.gov.

Individual participant data

Plan to share: Undecided — Depends on the demand - as noted on the Research Project Collaboration Guidelines

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jul 16, 2026, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT07707453
Lead sponsor
University of Fribourg
Responsible party
Marco Mancinetti (Clinical Professor, Department of General Internal Medicine, University of Fribourg) — Principal investigator
First posted
Jul 16, 2026
Start date
Aug 1, 2025
Primary completion
Dec 31, 2026 (estimated)
Completion
Dec 31, 2031 (estimated)
Last update
Jul 16, 2026

Study contacts

marco mancinetti, MD
Contact
marco.mancinetti@unifr.ch
0041263062360

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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