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

BACKGROUND: 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. METHODS: 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. RESULTS: 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. LIMITATIONS: 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. CONCLUSIONS: The additive value of the brief mindfulness-based stress management program was not confirmed in mental state and self-evaluated work efficiency.

A mindfulness-based stress management program and treatment with omega-3 fatty acids to maintain a healthy mental state in hospital nurses (Happy Nurse Project): study protocol for a randomized controlled trial.

BACKGROUND: It is reported that nursing is one of the most vulnerable jobs for developing depression. While they may not be clinically diagnosed as depressed, nurses often suffer from depression and anxiety symptoms, which can lead to a low level of patient care. However, there is no rigorous evidence base for determining an effective prevention strategy for these symptoms in nurses. After reviewing previous literature, we chose a strategy of treatment with omega-3 fatty acids and a mindfulness-based stress management program for this purpose. We aim to explore the effectiveness of these intervention options for junior nurses working in hospital wards in Japan. METHODS/DESIGN: A factorial-design multi-center randomized trial is currently being conducted. A total of 120 nurses without a managerial position, who work for general hospitals and gave informed consent, have been randomly allocated to a stress management program or psychoeducation using a leaflet, and to omega-3 fatty acids or identical placebo pills. The stress management program has been developed according to mindfulness cognitive therapy and consists of four 30-minute individual sessions conducted using a detailed manual. These sessions are conducted by nurses with a managerial position. Participants allocated to the omega-3 fatty acid groups are provided with 1,200 mg/day of eicosapentaenoic acid and 600 mg/day of docosahexaenoic acid for 90 days. The primary outcome is the change in the total score of the Hospital Anxiety and Depression Scale (HADS), determined by a blinded rater via the telephone at week 26. Secondary outcomes include the change in HADS score at 13 and 52 weeks; presence of a major depressive episode; severity of depression, anxiety, insomnia, burnout, and presenteeism; utility scores and adverse events at 13, 26 and 52 weeks. DISCUSSION: An effective preventive intervention may not only lead to the maintenance of a healthy mental state in nurses, but also to better quality of care for inpatients. This paper outlines the background and methods of a randomized trial that evaluates the possible additive value of omega-3 fatty acids and a mindfulness-based stress management program for reducing depression in nurses. TRIAL REGISTRATION: Clinicaltrials.gov: NCT02151162 (registered on 27 May 2014).