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Background <p>The post-discharge period following psychiatric hospitalization is a high-risk period for suicide attempts. This risk is substantially higher for patients admitted for suicidal behavior. Despite the urgent need for effective countermeasures, evidence-based interventions specifically designed to prevent suicide reattempts in this high-risk population remain limited. Although assertive case management is recognized as an effective intervention, its feasibility, safety, and efficacy for patients in psychiatric hospitals remain uninvestigated. The ACTION-JP study aims to evaluate the feasibility, safety, and efficacy of such an intervention adapted for patients in Japan admitted to psychiatric hospitals following a suicide attempt.</p> Methods <p>The ACTION-JP study is a multicenter, single-arm clinical trial. A total of 220 adult patients admitted to participating psychiatric hospitals following a suicide attempt will be enrolled. The intervention comprises two main components: a psychoeducation program conducted during hospitalization and an 18-month structured assertive case management follow-up. The primary outcome is the change from baseline in the Columbia-Suicide Severity Rating Scale total score at the 6-month follow-up. Secondary outcomes include the incidence of suicide reattempts and self-harm, as well as changes in Beck Depression Inventory-II and Global Assessment of Functioning Scale scores.</p> Discussion <p>This study protocol describes the essential first step in developing an evidence-based suicide prevention strategy for psychiatric inpatients. This study will provide important data on the intervention’s feasibility, safety, and efficacy. The findings are expected to offer important insights into the potential effectiveness of assertive case management for reducing suicide risk post-discharge. The successful implementation of this study will provide the necessary basis for designing a future large-scale randomized controlled trial that may help to establish a new standard of care in psychiatric hospitals.</p> Trial registration <p>This trial was registered on the University Hospital Medical Information Network clinical trials registry: UMIN000057009 (Date of registration: April 1, 2025) and the Japan Registry for Clinical Trials: jRCT1010250041 (Date of registration: October 20, 2025).</p>

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A multicenter, single-arm clinical trial of an assertive case management intervention for preventing suicide reattempts at psychiatric hospitals in Japan: ACTION-JP study

  • 期刊论文

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  • 发表日期：

    2025年11月28日

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  • Ryutaro Ishibashi,
  • Naohiro Yonemoto,
  • Yoshinori Cho,
  • Naoya Sugiyama,
  • Yoshiki Kishi,
  • Kiyoshi Fujita,
  • Masayuki Morikawa,
  • Masaru Tateno,
  • Yoko Kawahara,
  • Kotaro Otsuka,
  • Tomoaki Sano,
  • Kosuke Komata,
  • Chiaki Kawanishi

摘要

Background

The post-discharge period following psychiatric hospitalization is a high-risk period for suicide attempts. This risk is substantially higher for patients admitted for suicidal behavior. Despite the urgent need for effective countermeasures, evidence-based interventions specifically designed to prevent suicide reattempts in this high-risk population remain limited. Although assertive case management is recognized as an effective intervention, its feasibility, safety, and efficacy for patients in psychiatric hospitals remain uninvestigated. The ACTION-JP study aims to evaluate the feasibility, safety, and efficacy of such an intervention adapted for patients in Japan admitted to psychiatric hospitals following a suicide attempt.

Methods

The ACTION-JP study is a multicenter, single-arm clinical trial. A total of 220 adult patients admitted to participating psychiatric hospitals following a suicide attempt will be enrolled. The intervention comprises two main components: a psychoeducation program conducted during hospitalization and an 18-month structured assertive case management follow-up. The primary outcome is the change from baseline in the Columbia-Suicide Severity Rating Scale total score at the 6-month follow-up. Secondary outcomes include the incidence of suicide reattempts and self-harm, as well as changes in Beck Depression Inventory-II and Global Assessment of Functioning Scale scores.

Discussion

This study protocol describes the essential first step in developing an evidence-based suicide prevention strategy for psychiatric inpatients. This study will provide important data on the intervention’s feasibility, safety, and efficacy. The findings are expected to offer important insights into the potential effectiveness of assertive case management for reducing suicide risk post-discharge. The successful implementation of this study will provide the necessary basis for designing a future large-scale randomized controlled trial that may help to establish a new standard of care in psychiatric hospitals.

Trial registration

This trial was registered on the University Hospital Medical Information Network clinical trials registry: UMIN000057009 (Date of registration: April 1, 2025) and the Japan Registry for Clinical Trials: jRCT1010250041 (Date of registration: October 20, 2025).