RCT of Post-Suicide Attempt Case Management (ACTION-J)

Phase 3

Completed

• Conditions: Suicide Attempt
• Interventions: Behavioral: Case management; Other: Enhanced usual care

• Registration Number: NCT00736918
• Lead Sponsor: Japan Foundation for Neuroscience and Mental Health

Brief Summary

This study will determine the effectiveness of continuous follow-up care by case manager in preventing further suicide attempts

Detailed Description

It is well known that many subjects who survived a suicide attempt will make further suicide attempts, even after the medical treatment at critical emergency unit. To examine the effectiveness of continuous follow-up care by case manager after the suicide attempt, a randomized, controlled, multicenter trial by J-MISP (Japanese Multimodal Intervention Trials).This research project is one of the strategic research projects funded by The Japanese Ministry of Health, Labor and Welfare. In this study, J-MISP will implement the intervention for suicide attempters, a considerably high-risk group of further suicide attempts, who are transported by emergency services.

Study Timeline

• Study Start: 2006-06
• Study First Submitted: 2008-08-15
• Study First Submitted QC: 2008-08-15
• Study First Posted: 2008-08-18
• Primary Completion: 2011-06
• Study Completion: 2013-10
• Status Verified: 2014-01
• Last Update Submitted: 2014-01-14
• Last Update Posted: 2014-01-16

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 914

Inclusion Criteria

1. Over 20 years old
2. Suffering from Axis I disorder
3. Had intent for suicide (confirmed more than 2 times)
4. Able to understand this study and provide informed consent
5. Able to have interview before trial registry and psycho education at hospital
6. Able to have interview for assessment at continuous follow-up care by case manager at the hospital

Exclusion Criteria

1. Not suffering from Axis I disorder as a primary diagnosis

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Case management	Case management	Case management
Enhanced usual care	Enhanced usual care	Enhanced usual care

Primary Outcome Measures

Name	Time	Method
First recurrent suicide behavior (suicide attempted and completed suicide)	Minimum 1.5 year

Secondary Outcome Measures

Name	Time	Method
Any cause of death	Minimum 1.5 year
Repeated recurrent incidence of suicide attempts	Minimum 1.5 year
Utilization or personal or social resources	Minimum 1.5 year
SF-36	Minimum 1.5 year
Adverse events	Minimum 1.5 year
Health care utilization	Minimum 1.5 year
Physical function	Minimum 1.5 year
Number of self-injury	Minimum 1.5 year
Beck hopeless scale	Minimum 1.5 year

Trial Locations

Locations (18)

National Hospital Organization, Osaka Medical Center; 🇯🇵 Osaka, Japan

Kitazato University Hospital; 🇯🇵 Sagamihara, Kanagawa, Japan

Yokohama City University Medical Center; 🇯🇵 Yokohama, Kanagawa, Japan

Nara Medical University Hospital; 🇯🇵 Kashihara, Nara, Japan

Oita Kouseiren Tsurumi Hospital; 🇯🇵 Beppu, Oita, Japan

Kinki University Hospital; 🇯🇵 Sayama, Osaka, Japan

Saitama Medical University Hospital; 🇯🇵 Moroyama, Saitama, Japan

Tsukuba Medical Center; 🇯🇵 Tsukuba, Ibaraki, Japan

Iwate Medical University Hospital; 🇯🇵 Morioka, Iwate, Japan

Oita University Hospital; 🇯🇵 Yufu, Oita, Japan

Nihon Medical University Hospital; 🇯🇵 Tokyo, Japan

Fukuoka University Hospital; 🇯🇵 Fukuoka, Japan

Showa University Hospital; 🇯🇵 Tokyo, Japan

Kansai Medical University Takii Hospital; 🇯🇵 Moriguchi, Osaka, Japan

Saitama Medical University Medical Center; 🇯🇵 Kawagoe, Saitama, Japan

National Hospital Organization, Mito Medical Center; 🇯🇵 Mito, Ibaraki, Japan

Fujita Health University Hospital; 🇯🇵 Toyoake, Aichi, Japan

Tsuchiura Kyodo Hospital; 🇯🇵 Tsuchiura, Ibaraki, Japan