1.
A quasi-cluster randomized controlled trial of a classroom-based mental health literacy educational intervention to promote knowledge and help-seeking/helping behavior in adolescents.
Yamaguchi, S, Ojio, Y, Foo, JC, Michigami, E, Usami, S, Fuyama, T, Onuma, K, Oshima, N, Ando, S, Togo, F, et al
Journal of adolescence. 2020;:58-66
Abstract
INTRODUCTION School-based education is a potentially effective approach for improving mental health literacy (MHL) in adolescents. This study evaluated the effects of the "Short MHL Program (SMHLP)", a brief (50 min), school teacher-led program, on MHL in adolescents in a quasi-cluster randomized controlled trial. METHODS A total of 975 high school first graders (age 15-16) in Japan were allocated to classes such that gender and academic achievement ratios were almost equivalent at the time of admission to the high school. They were assigned at the class level to the SMHLP (n = 364 from 10 classes) or a control group (n = 611 from 17 classes). The program consisted of a 50-minute session and was delivered by a school teacher. The students completed a self-report questionnaire at 3 time points: pre-, (immediately) post- and 2-month follow-up. Outcomes included "Knowledge about mental health/illnesses", "Recognition of the necessity to seek help", "Intention to seek help", and "Intention of helping peers". Mixed effects modeling was employed for analyses. RESULTS Scores of all outcomes were significantly improved in the intervention group compared to the control group post-intervention (p < .001). These improvements were maintained at 2-months follow-up for all outcomes (p < .001-.05). Questionnaire scores did not differ between groups at baseline. CONCLUSIONS The effect of the SMHLP was confirmed in grade 10 students. Brief, yet effective programs can be a viable option to promote understanding of mental health problems and have the potential to be incorporated into regular school curriculum. ".
2.
Rationale and design of the EMPYREAN study.
Motoki, H, Masuda, I, Yasuno, S, Oba, K, Shoin, W, Usami, S, Saito, Y, Waki, M, Komatsu, M, Ueshima, K, et al
ESC heart failure. 2020;(5):3134-3141
Abstract
AIMS: A sodium glucose cotransporter 2 (SGLT2) inhibitor was recently found to reduce heart failure hospitalization in the EMPA-REG OUTCOME trial. We have hypothesized that autonomic nerve activity may be modulated by SGLT2 inhibition. The current study aims to investigate the impact of empagliflozin on sympathetic and parasympathetic nerve activity in patients with type 2 diabetes mellitus. METHODS AND RESULTS This ongoing study is a prospective, randomized, open-label, multicentre investigation of 134 patients with type 2 diabetes mellitus. The patients are randomly allocated to receive either empagliflozin or sitagliptin with the treatment goal of the Japan Diabetes Society guidelines. Ambulatory electrocardiographic monitoring is performed at the baseline and at 12 and 24 weeks of treatment. Analyses of heart rate variability are conducted using the MemCalc method, which is a combination of the maximum entropy method for spectral analysis and the non-linear least squares method for square analysis. The primary endpoint is the change in the low-frequency (0.04-0.15 Hz)/high-frequency (0.15-0.4 Hz) ratio from baseline to 24 weeks. CONCLUSIONS This investigation on the effect of EMPagliflozin on cardiac sYmpathetic and parasympathetic neRve activity in JapanEse pAtieNts with type 2 diabetes (EMPYREAN study) offers an important opportunity to understand the impact of SGLT2 inhibition on autonomic nerve activity in patients with type 2 diabetes.