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

Study Overview
=================
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.

Official Title
-----------------
A Randomized Controlled Multicenter Trial of Post-Suicide Attempt Case Management for the Prevention of Further Attempts in Japan (ACTION-J)

Conditions
-----------------
Suicide Attempt

Intervention / Treatment
-----------------
* Behavioral: Case management
* Other: Enhanced usual care


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Over 20 years old Suffering from Axis I disorder Had intent for suicide (confirmed more than 2 times) Able to understand this study and provide informed consent Able to have interview before trial registry and psycho education at hospital Able to have interview for assessment at continuous follow-up care by case manager at the hospital Exclusion Criteria: Not suffering from Axis I disorder as a primary diagnosis

Ages Eligible for Study
-----------------
Minimum Age: 20 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Case management<br>Case management | Behavioral: Case management<br>* Case management, Usual clinical practice and Providing paper based information for suicide prevention<br>|
| Active Comparator: Enhanced usual care<br>Enhanced usual care | Other: Enhanced usual care<br>* Usual clinical practice and Providing paper based information for suicide prevention<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| First recurrent suicide behavior (suicide attempted and completed suicide) |  | Minimum 1.5 year | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 
| Number of self-injury |  | Minimum 1.5 year | 
| Health care utilization |  | Minimum 1.5 year | 
| Physical function |  | Minimum 1.5 year | 
| Beck hopeless scale |  | Minimum 1.5 year | 
| SF-36 |  | Minimum 1.5 year | 
| Adverse events |  | Minimum 1.5 year | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Suicide Attempt