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Background  Among Chinese medical students, there is a high prevalence of mental health-related issues and low empathy. Effective strategies to improve this situation are lacking. This study aims to investigate the efficacy of the intervention courses designed to enhance the mental health and empathy of senior Chinese medical students.    Methods  A total of 146 3rd - and 4th -year medical students were randomized to an intervention group ( n  = 74) and a control group ( n  = 72). A pilot study including 5 pre-clinical students and 5 interns was first carried out to determine the themes and content of the intervention courses. The designed courses were delivered in the intervention group once a month three times, while the control group had no specific intervention. Five self-assessment questionnaires, including the General Self-Efficacy (GSE) scale, Medical Outcomes Study Short Form 8 (SF-8), Patient Health Questionnaire-9 (PHQ-9), Maslach Burnout Inventory (MBI), and Jefferson Scale of Empathy-Health Care Provider Student version (JSE-HPS), were completed by the students before and one month after the courses to evaluate their levels of self-efficacy (SE), quality of life (QoL), depression, burnout, and empathy, respectively. Qualitative data were collected via e-mail two years after the intervention.    Results  Compared to the control group, the intervention group showed significantly higher scores for empathy (111.0 [IQR 102.0, 118.0] vs. 106.0 [IQR 93.0, 111.5];  P  = .01) and QoL (32.0 [IQR 28.0, 35.0] vs. 29.5 [IQR 26.0, 34.0];  P  = .04). The rate of depression was significantly lower in the intervention group than in the control group (13.5 % vs. 29.2 %; chi-square test,  P  = .02). However, no significant differences in self-efficacy (25.6 ± 4.8 vs. 24.3 ± 6.3;  P  = .16) or burnout (27.0 % vs. 34.7 %; Chi-square test,  P  = .31) were observed between the two groups.    Conclusions  The intervention courses had a positive impact on mental well-being and empathy in senior Chinese medical students, which might help provide novel information for their incorporation into the medical school curriculum.    Trial registration   ClinicalTrials.gov Identifier : NCT02645643;  Date of registration : 05/01/2016.    Supplementary Information  The online version contains supplementary material available at 10.1186/s12909-021-02813-6.

Improvement of the management of mental well-being and empathy in Chinese medical students: a randomized controlled study