Burnout SyndromeCOMETNCT07707453
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 of Burnout Syndrome and Depression Disorder, run by University of Fribourg at 3 sites in Switzerland.
Trial 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. Read more about this study
- Who is it for?
- Any ageHealthy volunteers can take part
- Conditions the study is for
- Burnout Syndrome, Depression Disorder, Insomnia
- How many people
- 800 participants
- Where
- 3 sitesSwitzerland
- Study dates
- 1 Aug 2025to 31 Dec 2031
- How long will I take part?
- 5 Years
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Study population: resident physicians in general internal medicine at approximately 22 Swiss hospital and ambulatory centres (~1,300 eligible)
Who may be able to join
- Resident physician in general internal medicine employed at a participating study site or annex centre during the recruitment period Written informed consent
Who cannot join
- Not providing direct patient care Severe mental or physical condition precluding informed consent or compliance with the protocol
Trial locations and contacts
3 sites in 1 country. Contact the study team or a site near you to ask about taking part.
Switzerland3 sites, 3 recruiting
- Recruiting
Inselspital - University Hospital
Bern
Stefanie Mosimann, 0041316322111, stefanie.mosimann@insel.ch
- Recruiting
HFR - Hôpital Cantonal
Fribourg, 1700
Marco Mancinetti, MD, 0041263062360, marco.mancinetti@unifr.ch
- Recruiting
CHUV - University Hospital
Lausanne
Vanessa Kraege, 004121 314 11 11, vanessa.kraege@chuv.ch
About this study
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.
Read more
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.
- Conditions
- Burnout Syndrome, Depression Disorder, Insomnia, Perceived Stress, Fatigue Symptom, Empathy
- Medical subject headings
- Burnout, Psychological, Sleep Initiation and Maintenance Disorders, Fatigue
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Residents in General Internal Medicine (GIM) | All residents in GIM in the participating centers in Switzerland |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 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
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
Measured: 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
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
Measured: 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)
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.
Measured: Baseline and annually at years 1, 2, 3, 4 and 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
Measured: Annually at years 1, 2, 3, 4 and 5
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)
Measured: Baseline and annually at years 1, 2, 3, 4 and 5
Secondary outcomes (13)
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.
Measured: 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)
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)
Measured: 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
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).
Measured: 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
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)
Measured: 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
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)
Measured: 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
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.
Measured: Baseline and annually at years 1, 2, 3, 4 and 5
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
Measured: 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)
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
Measured: Baseline and annually at years 1, 2, 3, 4 and 5
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).
Measured: Baseline and annually at years 1, 2, 3, 4 and 5
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)
Measured: 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)
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.
Measured: 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)
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)
Measured: Baseline
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)
Measured: Baseline and year 5
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Jul 2026
- Study start1 Aug 2025
- Primary completion31 Dec 2026 (estimated)
- Study completion31 Dec 2031 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Burnout SyndromeStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 800 participants (estimated)
- Target duration
- 5 Years
Sponsor and investigators
- Lead sponsor
- University of Fribourg
- Sponsor type
- University, hospital or other
- Collaborators
- Insel Gruppe AG, University Hospital Bern, Hôpital Fribourgeois, University of Lausanne Hospitals
- Responsible party
- Principal investigator, Marco Mancinetti, University of Fribourg
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07707453
- Sponsor's protocol ID
- CERV-VD Project-ID 2024-00444
- Acronym
- COMET
- Status last verified
- Jul 2026
- First submitted
- 9 Jul 2026
- Last updated
- 16 Jul 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided: Depends on the demand - as noted on the Research Project Collaboration Guidelines
Study at a glance
From the registry record, last updated by the sponsor on 16 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The COMET Study: a Prospective COhort of MEdical residenTs to Assess Professional, Personal and Psychological Trajectories of Residents in General Internal Medicine
- ClinicalTrials.gov ID
- NCT07707453
- Acronym / sponsor ID
- COMET / CERV-VD Project-ID 2024-00444
- Conditions
- Burnout Syndrome, Depression Disorder, Insomnia, Perceived Stress, Fatigue Symptom, Empathy
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 800 participants (estimated)
- Lead sponsor
- University of FribourgUniversity, hospital or other
- Collaborators
- Insel Gruppe AG, University Hospital Bern, Hôpital Fribourgeois, University of Lausanne Hospitals
- Study start
- 1 Aug 2025 (actual)
- Primary completion
- 31 Dec 2026 (estimated)
- Study completion
- 31 Dec 2031 (estimated)
- First posted
- 16 Jul 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 5 Years
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Residents in General Internal Medicine (GIM) | – | –All residents in GIM in the participating centers in Switzerland |
Who may qualify
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
- Study population
- resident physicians in general internal medicine at approximately 22 Swiss hospital and ambulatory centres (~1,300 eligible)
Key inclusion criteria (1 listed)
- Resident physician in general internal medicine employed at a participating study site or annex centre during the recruitment period Written informed consent
Key exclusion criteria (1 listed)
- Not providing direct patient care Severe mental or physical condition precluding informed consent or compliance with the protocol
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
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
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
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
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
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
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
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
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.
Percentage of participants remaining in general internal medicine training or practice
Time frame: Annually at years 1, 2, 3, 4 and 5
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
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
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)
13 secondary outcomes
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
Difference in QCAE empathy scores between residents and Swiss medical students
Time frame: Baseline and year 5
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Jul 2026.
- Individual participant dataSharing planned: Undecided. Depends on the demand - as noted on the Research Project Collaboration Guidelines
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Burnout Syndrome and Depression Disorder, run by University of Fribourg at 3 sites in Switzerland.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 16 Jul 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in Switzerland. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact marco mancinetti, MD (0041263062360, marco.mancinetti@unifr.ch), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). The study lists 6 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 Jul 2026.