O-63 - ACTION-J: a randomized, controlled, multicenter trial of post-suicide attempt case management for the prevention of further attempts in Japan

Objective A history of previous suicide attempt is a potent risk factor for suicide later on. Crisis intervention initiated at emergency medical facilities for suicide attempters are considered important components for suicide prevention. The primary aim of this trial is to examine the effectiveness of an extensive intervention for suicide attempters in prevention of recurrent suicidal behavior, as compared with standard intervention. Methods/design ACTION-J is a single blinded randomized controlled trial. In this trial, case management intervention were provided at 19 emergency medical facilities in Japan. After psychiatric evaluation and psychological education, subjects were randomly assigned to either a group receiving continuous case management or standard care. Suicidal ideation, depressive symptoms, and general health condition were evaluated as secondary measures. The stratified logrank test based on allocation factors will be performed for all eligible participants in the intent-to-treat analysis. The study protocol was reviewed and approved by the Central Ethics Committee of the J-MISP. The protocol was also reviewed and approved by the On-site Research Ethics Committee at each participating hospital. Results/progress The intervention was initiated in July 2006. By December 2009, 914 subjects were randomized. Subject follow-up continued for 1.5 to 5 years, till the end of June 2011. ACTION-J would provide valuable information on suicide attempters and may develop effective case management to reduce future risk for suicide attempters. (ClinicalTrials.gov: NCT00736918.)