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

This study is ongoing, but not recruiting participants.
Sponsor:
Collaborator:
National Center of Neurology and Psychiatry, Japan
Information provided by:
Japan Foundation for Neuroscience and Mental Health
ClinicalTrials.gov Identifier:
NCT00736918
First received: August 15, 2008
Last updated: July 24, 2011
Last verified: July 2011

August 15, 2008
July 24, 2011
June 2006
June 2011   (final data collection date for primary outcome measure)
Recurrent incidence rates of suicide attempts [ Time Frame: Minimum 1.5 year ] [ Designated as safety issue: Yes ]
Same as current
Complete list of historical versions of study NCT00736918 on ClinicalTrials.gov Archive Site
  • Any cause of death [ Time Frame: Minimum 1.5 year ] [ Designated as safety issue: Yes ]
  • Number and rates of repeated recurrent incidence of suicide attempts [ Time Frame: Minimum 1.5 year ] [ Designated as safety issue: Yes ]
  • Utilization or personal or social resources [ Time Frame: Minimum 1.5 year ] [ Designated as safety issue: No ]
  • Number of self-injury [ Time Frame: Minimum 1.5 year ] [ Designated as safety issue: Yes ]
  • Health care utilization [ Time Frame: Minimum 1.5 year ] [ Designated as safety issue: No ]
  • Physical function [ Time Frame: Minimum 1.5 year ] [ Designated as safety issue: Yes ]
  • Beck hopeless scale [ Time Frame: Minimum 1.5 year ] [ Designated as safety issue: No ]
  • SF-36 [ Time Frame: Minimum 1.5 year ] [ Designated as safety issue: No ]
  • Adverse events [ Time Frame: Minimum 1.5 year ] [ Designated as safety issue: Yes ]
Same as current
Not Provided
Not Provided
 
A Randomized Controlled Multicenter Trial of Post-Suicide Attempt Case Management for the Prevention of Further Attempts in Japan (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
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Outcomes Assessor)
Primary Purpose: Prevention
Post-Suicide Attempt
  • Behavioral: Case management
    Case management, Usual clinical practice and Providing paper based information for suicide prevention
  • Other: Treatment as usual
    Usual clinical practice and Providing paper based information for suicide prevention
  • Experimental: 1
    Intervention: Behavioral: Case management
  • Active Comparator: 2
    Intervention: Other: Treatment as usual

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Active, not recruiting
842
December 2011
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
Both
20 Years and older
No
Contact information is only displayed when the study is recruiting subjects
Japan
 
NCT00736918
J-MISP-01, UMIN Trial ID: C000000444
Yes
Japan Foundation for Neuroscience and Mental Health,, Japanese Multimodal Intervention Trials for Suicide Prevention (J-MISP), Administration office
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
July 2011

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