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

This study has been completed.
Sponsor:
Collaborator:
National Center of Neurology and Psychiatry, Japan
Information provided by (Responsible Party):
Japan Foundation for Neuroscience and Mental Health
ClinicalTrials.gov Identifier:
NCT00736918
First received: August 15, 2008
Last updated: January 14, 2014
Last verified: January 2014
  Purpose

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


Condition Intervention Phase
Suicide Attempt
Behavioral: Case management
Other: Enhanced usual care
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Outcomes Assessor)
Primary Purpose: Prevention
Official Title: A Randomized Controlled Multicenter Trial of Post-Suicide Attempt Case Management for the Prevention of Further Attempts in Japan (ACTION-J)

Resource links provided by NLM:


Further study details as provided by Japan Foundation for Neuroscience and Mental Health:

Primary Outcome Measures:
  • First recurrent suicide behavior (suicide attempted and completed suicide) [ Time Frame: Minimum 1.5 year ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • Any cause of death [ Time Frame: Minimum 1.5 year ] [ Designated as safety issue: Yes ]
  • 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 ]

Other Outcome Measures:
  • Incidence proportion of the first episode of recurrent suicidal behaviour (attempted suicide or completed suicide) [ Time Frame: at 1 month after the randomization ] [ Designated as safety issue: Yes ]
  • Incidence proportion of the first episode of recurrent suicidal behaviour (attempted suicide or completed suicide) [ Time Frame: at 3 months after the randomization ] [ Designated as safety issue: Yes ]
  • Incidence proportion of the first episode of recurrent suicidal behaviour (attempted suicide or completed suicide) [ Time Frame: at 6 months after the randomization ] [ Designated as safety issue: Yes ]
  • Incidence proportion of the first episode of recurrent suicidal behaviour (attempted suicide or completed suicide) [ Time Frame: at 12 months after the randomization ] [ Designated as safety issue: Yes ]
  • Incidence proportion of the first episode of recurrent suicidal behaviour (attempted suicide or completed suicide) [ Time Frame: at 18 months after the randomization ] [ Designated as safety issue: Yes ]

Enrollment: 914
Study Start Date: June 2006
Study Completion Date: October 2013
Primary Completion Date: June 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Case management
Case management
Behavioral: Case management
Case management, Usual clinical practice and Providing paper based information for suicide prevention
Active Comparator: Enhanced usual care
Enhanced usual care
Other: Enhanced usual care
Usual clinical practice and Providing paper based information for suicide prevention

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.

  Eligibility

Ages Eligible for Study:   20 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00736918

Locations
Japan
Fujita Health University Hospital
Toyoake, Aichi, Japan, 470-1192
National Hospital Organization, Mito Medical Center
Mito, Ibaraki, Japan, 311-3198
Tsuchiura Kyodo Hospital
Tsuchiura, Ibaraki, Japan, 300-0053
Tsukuba Medical Center
Tsukuba, Ibaraki, Japan, 305-8558
Iwate Medical University Hospital
Morioka, Iwate, Japan, 020-0023
Kitazato University Hospital
Sagamihara, Kanagawa, Japan, 228-0829
Yokohama City University Medical Center
Yokohama, Kanagawa, Japan, 232-0024
Nara Medical University Hospital
Kashihara, Nara, Japan, 634-0813
Oita Kouseiren Tsurumi Hospital
Beppu, Oita, Japan, 874-8585
Oita University Hospital
Yufu, Oita, Japan, 897-5503
Kansai Medical University Takii Hospital
Moriguchi, Osaka, Japan, 570-0074
Kinki University Hospital
Sayama, Osaka, Japan, 589-0014
Saitama Medical University Medical Center
Kawagoe, Saitama, Japan, 350-8550
Saitama Medical University Hospital
Moroyama, Saitama, Japan, 350-0495
Fukuoka University Hospital
Fukuoka, Japan, 814-0128
National Hospital Organization, Osaka Medical Center
Osaka, Japan
Showa University Hospital
Tokyo, Japan, 142-0064
Nihon Medical University Hospital
Tokyo, Japan, 113-0022
Sponsors and Collaborators
Japan Foundation for Neuroscience and Mental Health
National Center of Neurology and Psychiatry, Japan
Investigators
Principal Investigator: Yoshio Hirayasu, MD,PhD Yokohama City University
  More Information

Publications:
Responsible Party: Japan Foundation for Neuroscience and Mental Health
ClinicalTrials.gov Identifier: NCT00736918     History of Changes
Other Study ID Numbers: J-MISP-01, C000000444
Study First Received: August 15, 2008
Last Updated: January 14, 2014
Health Authority: Japan: Ministry of Health, Labor and Welfare

Keywords provided by Japan Foundation for Neuroscience and Mental Health:
Suicide Attempt

Additional relevant MeSH terms:
Suicide
Suicide, Attempted
Self-Injurious Behavior
Behavioral Symptoms

ClinicalTrials.gov processed this record on April 17, 2014