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

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00736918
First Posted: August 18, 2008
Last Update Posted: January 16, 2014
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Collaborator:
National Center of Neurology and Psychiatry, Japan
Information provided by (Responsible Party):
Japan Foundation for Neuroscience and Mental Health
August 15, 2008
August 18, 2008
January 16, 2014
June 2006
June 2011   (Final data collection date for primary outcome measure)
First recurrent suicide behavior (suicide attempted and completed suicide) [ Time Frame: Minimum 1.5 year ]
Recurrent incidence rates of suicide attempts [ Time Frame: Minimum 1.5 year ]
Complete list of historical versions of study NCT00736918 on ClinicalTrials.gov Archive Site
  • Any cause of death [ Time Frame: Minimum 1.5 year ]
  • Repeated recurrent incidence of suicide attempts [ Time Frame: Minimum 1.5 year ]
  • Utilization or personal or social resources [ Time Frame: Minimum 1.5 year ]
  • Number of self-injury [ Time Frame: Minimum 1.5 year ]
  • Health care utilization [ Time Frame: Minimum 1.5 year ]
  • Physical function [ Time Frame: Minimum 1.5 year ]
  • Beck hopeless scale [ Time Frame: Minimum 1.5 year ]
  • SF-36 [ Time Frame: Minimum 1.5 year ]
  • Adverse events [ Time Frame: Minimum 1.5 year ]
  • Any cause of death [ Time Frame: Minimum 1.5 year ]
  • Number and rates of repeated recurrent incidence of suicide attempts [ Time Frame: Minimum 1.5 year ]
  • Utilization or personal or social resources [ Time Frame: Minimum 1.5 year ]
  • Number of self-injury [ Time Frame: Minimum 1.5 year ]
  • Health care utilization [ Time Frame: Minimum 1.5 year ]
  • Physical function [ Time Frame: Minimum 1.5 year ]
  • Beck hopeless scale [ Time Frame: Minimum 1.5 year ]
  • SF-36 [ Time Frame: Minimum 1.5 year ]
  • Adverse events [ Time Frame: Minimum 1.5 year ]
  • Incidence proportion of the first episode of recurrent suicidal behaviour (attempted suicide or completed suicide) [ Time Frame: at 1 month after the randomization ]
  • Incidence proportion of the first episode of recurrent suicidal behaviour (attempted suicide or completed suicide) [ Time Frame: at 3 months after the randomization ]
  • Incidence proportion of the first episode of recurrent suicidal behaviour (attempted suicide or completed suicide) [ Time Frame: at 6 months after the randomization ]
  • Incidence proportion of the first episode of recurrent suicidal behaviour (attempted suicide or completed suicide) [ Time Frame: at 12 months after the randomization ]
  • Incidence proportion of the first episode of recurrent suicidal behaviour (attempted suicide or completed suicide) [ Time Frame: at 18 months after the randomization ]
Not Provided
 
RCT of Post-Suicide Attempt Case Management (ACTION-J)
A Randomized Controlled Multicenter Trial of Post-Suicide Attempt Case Management for the Prevention of Further Attempts in Japan (ACTION-J)
This study will determine the effectiveness of continuous follow-up care by case manager in preventing further suicide attempts
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.
Interventional
Phase 3
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Prevention
Suicide Attempt
  • Behavioral: Case management
    Case management, Usual clinical practice and Providing paper based information for suicide prevention
  • Other: Enhanced usual care
    Usual clinical practice and Providing paper based information for suicide prevention
  • Experimental: Case management
    Case management
    Intervention: Behavioral: Case management
  • Active Comparator: Enhanced usual care
    Enhanced usual care
    Intervention: Other: Enhanced usual care

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
914
October 2013
June 2011   (Final data collection date for primary outcome measure)

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
Sexes Eligible for Study: All
20 Years and older   (Adult, Senior)
No
Contact information is only displayed when the study is recruiting subjects
Japan
 
 
NCT00736918
J-MISP-01
C000000444 ( Registry Identifier: UMIN-CTR )
Yes
Not Provided
Not Provided
Japan Foundation for Neuroscience and Mental Health
Japan Foundation for Neuroscience and Mental Health
National Center of Neurology and Psychiatry, Japan
Principal Investigator: Yoshio Hirayasu, MD,PhD Yokohama City University
Japan Foundation for Neuroscience and Mental Health
January 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP