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  1. Article ; Online: Substance use and its association with mental health among Swiss medical students: A cross-sectional study.

    Gaume, Jacques / Carrard, Valérie / Berney, Sylvie / Bourquin, Céline / Berney, Alexandre

    The International journal of social psychiatry

    2024  , Page(s) 207640241232321

    Abstract: Background: Studies on mental health and substance use among medical students indicated worrying prevalence but have been mainly descriptive.: Aim: To evaluate the prevalence of substance use in a sample of medical students and investigate whether ... ...

    Abstract Background: Studies on mental health and substance use among medical students indicated worrying prevalence but have been mainly descriptive.
    Aim: To evaluate the prevalence of substance use in a sample of medical students and investigate whether mental health variables have an influence on substance use.
    Methods: The data were collected as part of the first wave of the ETMED-L, an ongoing longitudinal open cohort study surveying medical students at the University of Lausanne (Switzerland).
    Results: Statistical indices indicated a four-factor solution for mental health and a three-factor solution for substance use. A factor comprising risk level for alcohol, tobacco, and cannabis use - which were the most prevalent substances - was significantly associated with a burnout factor and a factor related to financial situation and side job stress. There was a significant association between a factor comprising depression, anxiety, and suicidal ideation and a factor related to the use of sedatives, nonmedical prescription drugs and neuroenhancement drugs. Although their use was less prevalent, a factor comprising the risk level of stimulants and cocaine use was significantly but more mildly related to the burnout factor. A factor comprising stress related to studies and work/life balance as well as emotional exhaustion was not related to substance use factors.
    Conclusion: In this sample of medical students, the prevalence of substance use was substantial and poorer mental health status was related with higher substance use risk levels.
    Language English
    Publishing date 2024-02-29
    Publishing country England
    Document type Journal Article
    ZDB-ID 3062-4
    ISSN 1741-2854 ; 0020-7640
    ISSN (online) 1741-2854
    ISSN 0020-7640
    DOI 10.1177/00207640241232321
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  2. Article ; Online: Exposure of medical students to sexism and sexual harassment and their association with mental health: a cross-sectional study at a Swiss medical school.

    Barbier, Jeanne Marie / Carrard, Valerie / Schwarz, Joelle / Berney, Sylvie / Clair, Carole / Berney, Alexandre

    BMJ open

    2023  Volume 13, Issue 4, Page(s) e069001

    Abstract: Objectives: To assess the self-reported prevalence of sexism and sexual harassment at a Swiss medical school, and to investigate their association with mental health. Research hypotheses were an association between sexism/sexual harassment and poor ... ...

    Abstract Objectives: To assess the self-reported prevalence of sexism and sexual harassment at a Swiss medical school, and to investigate their association with mental health. Research hypotheses were an association between sexism/sexual harassment and poor mental health and a higher prevalence of sexism/sexual harassment in clinical rotations.
    Design: Cross-sectional study as a part of ETMED-L project, an ongoing cohort study of interpersonal competences and mental health of medical students.
    Setting: Single-centre Swiss study using an online survey submitted to medical students.
    Participants: From 2096 registered students, 1059 were respondents (50.52%). We excluded 26 participants (25 due to wrong answers to attention questions, and 1 who did not answer the sexism exposure question). The final sample (N=1033) included 720 women, 300 men and 13 non-binary people.
    Measures: Prevalence of self-reported exposure to sexism/sexual harassment. Multivariate regression analyses of association between being targeted by sexism or sexual harassment and mental health (depression, suicidal ideation, anxiety, stress, burnout, substance use and recent mental health consultation). Regression models adjusted for gender, academic year, native language, parental education level, partnership and an extracurricular paid job.
    Results: Being targeted by sexism or sexual harassment was reported by 16% of participants with a majority of women (96%). The prevalence increased with clinical work. After adjusting for covariates, we found association between being targeted by sexism/harassment and risk of depression (OR 2.29, 95% CI 1.54 to 3.41, p<0.001), suicidal ideation (B coefficient (B) 0.37, p<0.001) and anxiety (B 3.69, p<0.001), as well as cynicism (B 1.46, p=0.001) and emotional exhaustion (B 0.94, p=0.044) components of burnout, substance use (B 6.51, p<0.001) and a recent mental health consultation (OR 1.78, 95% CI 1.10 to 2.66, p=0.005).
    Conclusions: Sexism and sexual harassment, although less common than usually reported, are behaviours of concern in this medical school and are significantly associated with mental health.
    MeSH term(s) Male ; Humans ; Female ; Sexual Harassment ; Sexism ; Mental Health ; Cross-Sectional Studies ; Students, Medical/psychology ; Schools, Medical ; Cohort Studies ; Switzerland/epidemiology ; Surveys and Questionnaires ; Burnout, Professional ; Substance-Related Disorders
    Language English
    Publishing date 2023-04-27
    Publishing country England
    Document type Journal Article ; Research Support, Non-U.S. Gov't
    ZDB-ID 2599832-8
    ISSN 2044-6055 ; 2044-6055
    ISSN (online) 2044-6055
    ISSN 2044-6055
    DOI 10.1136/bmjopen-2022-069001
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  3. Article: Validation of the French version of the Revised Diagnostic Interview for Borderlines (DIB-R) for assessing the psychopathology of borderline personality disorder.

    Culina, Ines / Maillard, Pauline / Loosli, Janice / Martin-Soelch, Chantal / Berney, Sylvie / Kolly, Stéphane / Kramer, Ueli

    Borderline personality disorder and emotion dysregulation

    2023  Volume 10, Issue 1, Page(s) 27

    Abstract: Background: Borderline personality disorder (BPD) is frequently subject to misdiagnosis or underdiagnosis. As a matter of fact, its evaluation poses several challenges, highlighting the importance of having validated evaluation instruments. The Revised ... ...

    Abstract Background: Borderline personality disorder (BPD) is frequently subject to misdiagnosis or underdiagnosis. As a matter of fact, its evaluation poses several challenges, highlighting the importance of having validated evaluation instruments. The Revised Diagnostic Interview for Borderlines (DIB-R) is widely used and recognized for its validity when it comes to assessing the psychopathology of BPD, but, as for now, no French version of the interview exists. The aim of the current work is to validate a French version of the DIB-R.
    Methods: The sample consists of N = 65 patients with borderline personality disorder (BPD) and N = 57 treatment seeking patients (non-BPD comparison group). For inter-rater reliability, a subsample of N = 84 interviews will be assessed by two raters, n = 47 for the BPD group and n = 37 for the non-BPD comparison group.
    Results: To assess reliability, we conducted analyses of internal consistency and inter-rater reliability. The results were good for the overall interview as well as for the four domains of the DIB-R. To assess validity, we calculated the receiver operating characteristic (ROC) curve, sensitivity, specificity, predictive values, convergent and discriminative validity. The optimal cutoff was found to be 7. Regarding convergent validity, we found strong convergence between the Borderline Symptom List (BSL-23) and the DIB-R total score. Additionally, the two groups statistically differed on all the DIB-R scores, which indicates that the interview discriminates between the two groups.
    Conclusions: Our results indicate good psychometric properties of the French version of the DIB-R. This has important implications as the interview is useful both in clinical settings and for research purposes. Additionally, the present paper aims to contribute to the more general effort of demonstrating generalizability and transportability of the scale.
    Language English
    Publishing date 2023-09-18
    Publishing country England
    Document type Journal Article
    ZDB-ID 2766243-3
    ISSN 2051-6673
    ISSN 2051-6673
    DOI 10.1186/s40479-023-00233-0
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  4. Article ; Online: Mental health and burnout during medical school: Longitudinal evolution and covariates.

    Carrard, Valerie / Berney, Sylvie / Bourquin, Céline / Ranjbar, Setareh / Castelao, Enrique / Schlegel, Katja / Gaume, Jacques / Bart, Pierre-Alexandre / Schmid Mast, Marianne / Preisig, Martin / Berney, Alexandre

    PloS one

    2024  Volume 19, Issue 4, Page(s) e0295100

    Abstract: Background: Medical students' rate of depression, suicidal ideation, anxiety, and burnout have been shown to be higher than those of the same-age general population. However, longitudinal studies spanning the whole course of medical school are scarce ... ...

    Abstract Background: Medical students' rate of depression, suicidal ideation, anxiety, and burnout have been shown to be higher than those of the same-age general population. However, longitudinal studies spanning the whole course of medical school are scarce and present contradictory findings. This study aims to analyze the longitudinal evolution of mental health and burnout from the first to the last year of medical school using a wide range of indicators. Moreover, biopsychosocial covariates that can influence this evolution are explored.
    Method: In an open cohort study design, 3066 annual questionnaires were filled in by 1595 different students from the first to the sixth year of the Lausanne Medical School (Switzerland). Depression symptoms, suicidal ideation, anxiety symptoms, stress, and burnout were measured along with biopsychosocial covariates. The longitudinal evolution of mental health and burnout and the impact of covariates were modelled with linear mixed models.
    Results: Comparison to a same-aged general population sample shows that medical students reported significantly more depression symptoms and anxiety symptoms. Medical students' mental health improved during the course of the studies in terms of depression symptoms, suicidal ideation, and stress, although suicidal ideation increased again in the last year and anxiety symptoms remained stable. Conversely, the results regarding burnout globally showed a significant worsening from beginning to end of medical school. The covariates most strongly related to better mental health and less burnout were less emotion-focused coping, more social support, and more satisfaction with health.
    Conclusion: Both improvement of mental health and worsening of burnout were observed during the course of medical school. This underlines that the beginning and the end of medical school bring specific challenges with the first years' stressors negatively impacting mental health and the last year's difficulties negatively impacting burnout.
    MeSH term(s) Humans ; Mental Health ; Depression/epidemiology ; Depression/psychology ; Schools, Medical ; Cohort Studies ; Burnout, Professional/epidemiology ; Burnout, Professional/psychology ; Students, Medical/psychology ; Suicidal Ideation
    Language English
    Publishing date 2024-04-16
    Publishing country United States
    Document type Journal Article
    ZDB-ID 2267670-3
    ISSN 1932-6203 ; 1932-6203
    ISSN (online) 1932-6203
    ISSN 1932-6203
    DOI 10.1371/journal.pone.0295100
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  5. Article: Psychiatrie : ce qui a changé en 2022.

    Berney, Sylvie / Mettraux, Michael / Franz, Tatjana / Candaux, François / Eggimann, Aude / Fehr, Nathalie / Abrahamyan Empson, Lilith / Conus, Philippe / Baumann, Philipp S

    Revue medicale suisse

    2022  Volume 19, Issue N° 809-10, Page(s) 82–85

    Abstract: The period of study and/or vocational training coincides with the phase of life where a large proportion of psychiatric disorders emerge. It is therefore common to be asked by a young person in training to make adjustments to his or her training for ... ...

    Title translation Psychiatry: what's new in 2022.
    Abstract The period of study and/or vocational training coincides with the phase of life where a large proportion of psychiatric disorders emerge. It is therefore common to be asked by a young person in training to make adjustments to his or her training for psychological reasons. Some disorders that were thought to occur in childhood also exist in adults: this is the case of attention deficit disorder with or without hyperactivity, which must be detected and treated appropriately. The tools available for the treatment of psychiatric disorders are not limited to medication and the usefulness of psychotherapy or physical approaches, for example, is well known. We are less aware of the beneficial effects of exposure to nature and green spaces, which are however solidly supported by scientific studies - and which we should not underestimate.
    MeSH term(s) Humans ; Male ; Adult ; Female ; Adolescent ; Psychiatry ; Attention Deficit Disorder with Hyperactivity/diagnosis ; Attention Deficit Disorder with Hyperactivity/therapy ; Attention Deficit Disorder with Hyperactivity/psychology ; Psychotherapy
    Language French
    Publishing date 2022-10-07
    Publishing country Switzerland
    Document type English Abstract ; Journal Article
    ZDB-ID 2177010-4
    ISSN 1660-9379
    ISSN 1660-9379
    DOI 10.53738/REVMED.2023.19.809-10.82
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  6. Article ; Online: The relationship between medical students' empathy, mental health, and burnout: A cross-sectional study.

    Carrard, Valerie / Bourquin, Céline / Berney, Sylvie / Schlegel, Katja / Gaume, Jacques / Bart, Pierre-Alexandre / Preisig, Martin / Schmid Mast, Marianne / Berney, Alexandre

    Medical teacher

    2022  Volume 44, Issue 12, Page(s) 1392–1399

    Abstract: Objective: To investigate how medical students' empathy is related to their mental health and burnout.: Methods: This cross-sectional study included 886 medical students from curriculum years 1-6. The cognitive, affective, and behavioural dimensions ... ...

    Abstract Objective: To investigate how medical students' empathy is related to their mental health and burnout.
    Methods: This cross-sectional study included 886 medical students from curriculum years 1-6. The cognitive, affective, and behavioural dimensions of empathy were measured with self-report questionnaires and an emotion recognition test. Regressions were used to test the relationship between the empathy dimensions, depressive symptoms, anxiety, and burnout as well as the influence of curriculum year and gender.
    Results: Cognitive and behavioural empathy were significantly related to less mental health issues and burnout, whereas affective empathy was related to more mental health issues and burnout. Students in later curriculum years reported less mental health issues and burnout than students in earlier years, whereas no systematic difference could be observed for empathy. Female students reported more mental health issues and burnout as well as higher empathy, except for behavioural empathy for which male students scored higher.
    Conclusions: The cognitive, affective, and behavioural dimensions of empathy were differently related to the mental health and burnout of medical students. Students presenting mental health issues or burnout might have more difficulty to adapt their behaviour in social situations and keep a certain distance when taking others' perspective.
    MeSH term(s) Male ; Female ; Humans ; Students, Medical/psychology ; Empathy ; Cross-Sectional Studies ; Mental Health ; Burnout, Professional/epidemiology ; Burnout, Professional/psychology ; Surveys and Questionnaires
    Language English
    Publishing date 2022-07-13
    Publishing country England
    Document type Journal Article
    ZDB-ID 424426-6
    ISSN 1466-187X ; 0142-159X
    ISSN (online) 1466-187X
    ISSN 0142-159X
    DOI 10.1080/0142159X.2022.2098708
    Database MEDical Literature Analysis and Retrieval System OnLINE

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  7. Article: Validation of the French version of the Revised Diagnostic Interview for Borderlines (DIB-R) for assessing the psychopathology of borderline personality disorder

    Culina, Ines / Maillard, Pauline / Loosli, Janice / Martin-Soelch, Chantal / Berney, Sylvie / Kolly, Stéphane / Kramer, Ueli

    Borderline Personality Disorder and Emotion Dysregulation

    2023  Volume 10, Issue 1, Page(s) No

    Abstract: Borderline personality disorder (BPD) is frequently subject to misdiagnosis or underdiagnosis. As a matter of fact, its evaluation poses several challenges, highlighting the importance of having validated evaluation instruments. The Revised Diagnostic ... ...

    Title translation Validierung der französischen Version des revidierten diagnostischen Interviews für Borderline-Persönlichkeitsstörungen (DIB-R) zur Beurteilung der Psychopathologie der Borderline-Persönlichkeitsstörung. (DeepL)
    Abstract Borderline personality disorder (BPD) is frequently subject to misdiagnosis or underdiagnosis. As a matter of fact, its evaluation poses several challenges, highlighting the importance of having validated evaluation instruments. The Revised Diagnostic Interview for Borderlines (DIB-R) is widely used and recognized for its validity when it comes to assessing the psychopathology of BPD, but, as for now, no French version of the interview exists. The aim of the current work is to validate a French version of the DIB-R.The sample consists of N = 65 patients with borderline personality disorder (BPD) and N = 57 treatment seeking patients (non-BPD comparison group). For inter-rater reliability, a subsample of N = 84 interviews will be assessed by two raters, n = 47 for the BPD group and n = 37 for the non-BPD comparison group.To assess reliability, we conducted analyses of internal consistency and inter-rater reliability. The results were good for the overall interview as well as for the four domains of the DIB-R. To assess validity, we calculated the receiver operating characteristic (ROC) curve, sensitivity, specificity, predictive values, convergent and discriminative validity. The optimal cutoff was found to be 7. Regarding convergent validity, we found strong convergence between the Borderline Symptom List (BSL-23) and the DIB-R total score. Additionally, the two groups statistically differed on all the DIB-R scores, which indicates that the interview discriminates between the two groups.Our results indicate good psychometric properties of the French version of the DIB-R. This has important implications as the interview is useful both in clinical settings and for research purposes. Additionally, the present paper aims to contribute to the more general effort of demonstrating generalizability and transportability of the scale.
    Keywords Borderline Personality Disorder ; Borderline-Persönlichkeit ; Foreign Language Translation ; Fragebögen ; Fremdsprachenübersetzung ; Interviews ; Questionnaires ; Test Reliability ; Test Validity ; Testreliabilität ; Testvalidität
    Language English
    Document type Article
    DOI 10.1186/s40479-023-00233-0
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  8. Article: The relationship between medical students' empathy, mental health, and burnout

    Carrard, Valerie / Bourquin, Céline / Berney, Sylvie / Schlegel, Katja / Gaume, Jacques / Bart, Pierre-Alexandre / Preisig, Martin / Mast, Marianne Schmid / Berney, Alexandre

    Medical Teacher

    A cross-sectional study

    2022  Volume 44, Issue 12, Page(s) 1392–1399

    Abstract: Objective: To investigate how medical students' empathy is related to their mental health and burnout. Methods: This cross-sectional study included 886 medical students from curriculum years 1-6. The cognitive, affective, and behavioural dimensions of ... ...

    Title translation Zusammenhang zwischen Empathie, psychischer Gesundheit und Burnout bei Medizinstudenten: Eine Querschnittsstudie (DeepL)
    Abstract Objective: To investigate how medical students' empathy is related to their mental health and burnout. Methods: This cross-sectional study included 886 medical students from curriculum years 1-6. The cognitive, affective, and behavioural dimensions of empathy were measured with self-report questionnaires and an emotion recognition test. Regressions were used to test the relationship between the empathy dimensions, depressive symptoms, anxiety, and burnout as well as the influence of curriculum year and gender. Results: Cognitive and behavioural empathy were significantly related to less mental health issues and burnout, whereas affective empathy was related to more mental health issues and burnout. Students in later curriculum years reported less mental health issues and burnout than students in earlier years, whereas no systematic difference could be observed for empathy. Female students reported more mental health issues and burnout as well as higher empathy, except for behavioural empathy for which male students scored higher. Conclusions: The cognitive, affective, and behavioural dimensions of empathy were differently related to the mental health and burnout of medical students. Students presenting mental health issues or burnout might have more difficulty to adapt their behaviour in social situations and keep a certain distance when taking others' perspective.
    Keywords Angst ; Anxiety ; Behavior ; Burnout ; Cognition ; Distress ; Emotionale Belastung ; Emotionen ; Emotions ; Empathie ; Empathy ; Erfahrungsniveau ; Experience Level ; Geschlechtsunterschiede beim Menschen ; Human Sex Differences ; Kognition (Erkenntnisprozess) ; Medical Students ; Medizinstudierende ; Mental Health ; Psychische Gesundheit ; Verhalten
    Language English
    Document type Article
    ZDB-ID 424426-6
    ISSN 1466-187X ; 0142-159X
    ISSN (online) 1466-187X
    ISSN 0142-159X
    DOI 10.1080/0142159X.2022.2098708
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  9. Article ; Online: Study protocol for the ETMED-L project: longitudinal study of mental health and interpersonal competence of medical students in a Swiss university using a comprehensive framework of empathy.

    Berney, Alexandre / Carrard, Valerie / Berney, Sylvie / Schlegel, Katja / Gaume, Jacques / Gholam, Mehdi / Bart, Pierre-Alexandre / Preisig, Martin / Wac, Katarzyna / Schmid Mast, Marianne / Bourquin, Céline

    BMJ open

    2021  Volume 11, Issue 12, Page(s) e053070

    Abstract: Introduction: Physician interpersonal competence is crucial for patient care. How interpersonal competence develops during undergraduate medical education is thus a key issue. Literature on the topic consists predominantly of studies on empathy showing ... ...

    Abstract Introduction: Physician interpersonal competence is crucial for patient care. How interpersonal competence develops during undergraduate medical education is thus a key issue. Literature on the topic consists predominantly of studies on empathy showing a trend of decline over the course of medical school. However, most existing studies have focused on narrow measures of empathy. The first aim of this project is to study medical students' interpersonal competence with a comprehensive framework of empathy that includes self-reported cognitive and affective empathy, performance-based assessments of emotion recognition accuracy, and a behavioural dimension of empathy. The second aim of the present project is to investigate the evolution of mental health during medical school and its putative link to the studied components of interpersonal competence. Indeed, studies documented a high prevalence of mental health issues among medical students that could potentially impact their interpersonal competence. Finally, this project will enable to test the impact of mental health and interpersonal competence on clinical skills as evaluated by experts and simulated patients.
    Methods and analysis: This project consists of an observational longitudinal study with an open cohort design. Each year during the four consecutive years of the project, every medical student (curriculum years 1-6) of the University of Lausanne in Switzerland will be asked to complete an online questionnaire including several interpersonal competence and mental health measures. Clinical skills assessments from examinations and training courses with simulated patients will also be included. Linear mixed models will be used to explore the longitudinal evolutions of the studied components of interpersonal competence and mental health as well as their reciprocal relationship and their link to clinical skills.
    Ethics and dissemination: The project has received ethical approval from the competent authorities. Findings will be disseminated through internal, regional, national and international conferences, news and peer-reviewed journals.
    MeSH term(s) Clinical Competence ; Education, Medical, Undergraduate/methods ; Empathy ; Humans ; Longitudinal Studies ; Mental Health ; Observational Studies as Topic ; Students, Medical/psychology ; Switzerland ; Universities
    Language English
    Publishing date 2021-12-03
    Publishing country England
    Document type Journal Article ; Research Support, Non-U.S. Gov't
    ZDB-ID 2599832-8
    ISSN 2044-6055 ; 2044-6055
    ISSN (online) 2044-6055
    ISSN 2044-6055
    DOI 10.1136/bmjopen-2021-053070
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  10. Article: Study protocol for the ETMED-L project

    Berney, Alexandre / Carrard, Valerie / Berney, Sylvie / Schlegel, Katja / Gaume, Jacques / Gholam, Mehdi / Bart, Pierre-Alexandre / Preisig, Martin / Wac, Katarzyna / Schmid Mast, Marianne / Bourquin, Céline

    BMJ Open

    Longitudinal study of mental health and interpersonal competence of medical students in a Swiss university using a comprehensive framework of empathy

    2021  Volume 11, Issue 12, Page(s) No

    Abstract: Introduction: Physician interpersonal competence is crucial for patient care. How interpersonal competence develops during undergraduate medical education is thus a key issue. Literature on the topic consists predominantly of studies on empathy showing a ...

    Title translation Studienprotokoll für das Projekt ETMED-L: Längsschnittstudie zur psychischen Gesundheit und zwischenmenschlichen Kompetenz von Medizinstudenten an einer Schweizer Universität unter Verwendung eines umfassenden Rahmens für Empathie
    Abstract Introduction: Physician interpersonal competence is crucial for patient care. How interpersonal competence develops during undergraduate medical education is thus a key issue. Literature on the topic consists predominantly of studies on empathy showing a trend of decline over the course of medical school. However, most existing studies have focused on narrow measures of empathy. The first aim of this project is to study medical students' interpersonal competence with a comprehensive framework of empathy that includes self-reported cognitive and affective empathy, performance-based assessments of emotion recognition accuracy, and a behavioural dimension of empathy. The second aim of the present project is to investigate the evolution of mental health during medical school and its putative link to the studied components of interpersonal competence. Indeed, studies documented a high prevalence of mental health issues among medical students that could potentially impact their interpersonal competence. Finally, this project will enable to test the impact of mental health and interpersonal competence on clinical skills as evaluated by experts and simulated patients. Methods and analysis: This project consists of an observational longitudinal study with an open cohort design. Each year during the four consecutive years of the project, every medical student (curriculum years 1-6) of the University of Lausanne in Switzerland will be asked to complete an online questionnaire including several interpersonal competence and mental health measures. Clinical skills assessments from examinations and training courses with simulated patients will also be included. Linear mixed models will be used to explore the longitudinal evolutions of the studied components of interpersonal competence and mental health as well as their reciprocal relationship and their link to clinical skills. Ethics and dissemination: The project has received ethical approval from the competent authorities. Findings will be disseminated through internal, regional, national and international conferences, news and peer-reviewed journals.
    Keywords Communication Skills ; Empathie ; Empathy ; Kommunikationsfertigkeiten ; Medical Education ; Medical Students ; Medizinische Ausbildung ; Medizinstudierende ; Mental Health ; Psychische Gesundheit ; Social Skills ; Soziale Fertigkeiten
    Language English
    Document type Article
    ZDB-ID 2599832-8
    ISSN 2044-6055
    ISSN 2044-6055
    DOI 10.1136/bmjopen-2021-053070
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