Brief mindfulness-based stress management program for a better mental state in working populations - Happy Nurse Project: A randomized controlled trial

•The effectiveness of brief mindfulness-based stress management program for prevention of depression was examined.•Eighty nurses were randomly allocated to the program or psychoeducation leaflet for 13 weeks.•Information about depression, anxiety and presenteeism was collected up to 52 weeks.•No clinically important difference was comfirmed between two intervention arms. The efficacy of the mindfulness-based stress management program for maintaining a better mental state has not been examined among working populations. We aimed to explore the effectiveness of the brief mindfulness-based stress management program for hospital nurses. In a multi-center randomized trial, 80 junior nurses working in hospitals were randomly allocated either to the brief mindfulness-based stress management program or psychoeducation using a leaflet. The program consisted of four 30 min individual sessions conducted by trained senior nurses using a detailed manual. The primary outcome was the total score of the Hospital Anxiety and Depression Scale (HADS) at week 26. Secondary outcomes included presence of a major depressive episode; severity of depression, anxiety, insomnia, burnout, and presenteeism; utility scores; and adverse events up to 52 weeks. The mean HADS score of all the participants at baseline was 7.2. At 26 weeks, adjusted mean scores on the HADS score were 7.2 (95% confidence intervals: 5.9, 8. 5) in the program group and 6.0 (4.8, 7.2) in the leaflet group, respectively. The coefficient of the group by time interaction was not statistically significant at -1.41 (-3.35, 0.54; P = 0.156). No significant superiority or inferiority was observed on the other outcomes. We did not manage to recruit the number of participants we initially set out, although our post-hoc analyses showed that this did not lead to changes in our conclusions. The additive value of the brief mindfulness-based stress management program was not confirmed in mental state and self-evaluated work efficiency.