NeuroFinance Human Stress Trial During Financial and Informational Volatility
NCT07622589
Anxiety, Anxiety Disorders
New York, United States
View Trial DetailsNCT Number: NCT07707453
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.
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Observational
Inselspital - University Hospital, Bern, Switzerland
Healthy volunteers accepted: Yes
Only the study team can determine whether someone qualifies for participation.
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
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
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
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
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.
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
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)
Time frame: Baseline and annually at years 1, 2, 3, 4 and 5
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
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
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
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
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
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
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
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
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
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
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
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 and year 5
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)
Contact information is provided by the study sponsor or research team.
University of Fribourg
Other
Acronym: COMET
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