Classroom-based cognitive behavioural therapy: a large-scale non-randomised controlled trial of the 'Journey of the Brave'.

BACKGROUND In Japan, 'Journey of the Brave', a cognitive behavioural therapy (CBT)-based anxiety preventive education programme, was previously developed and its effectiveness examined in two small-scale controlled trials. These studies had some limitations, including a small number of participants and not having regular classroom teachers as programme facilitators. Therefore, we conducted a large-scale controlled trial, with teachers as programme implementers. METHODS Twenty-seven elementary schools participated: 1622 and 1123 children were allocated to the intervention and control groups, respectively. The intervention group received a programme comprising ten 45-min sessions, while the control group underwent the regular school curriculum. Anxiety symptoms among participants were assessed using the Spence Children's Anxiety Scale (SCAS) at three stages (pre-intervention, post-intervention, and follow-up). RESULTS Following primary analysis, estimated mean changes in SCAS from baseline to follow-up were - 4.91 (95% CI - 5.91, - 3.90) in the intervention group and - 2.53 (95% CI - 3.52, - 1.54) in the control group; the group difference was 2.37 (95% CI 1.42, 3.33, p < 0.0001). Children in the intervention group showed significant reduction in their anxiety score versus children in the control group. CONCLUSIONS The results showed a statistically significant anxiety score reduction in the intervention group, thus verifying the programme's effectiveness. Trial registration The University Hospital Medical Information Network (UMIN): UMIN000032517. Registered 10 May 2018-Retrospectively registered, https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000037083.