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

Primary Purpose

Suicide Attempt

Status
Completed
Phase
Phase 3
Locations
Japan
Study Type
Interventional
Intervention
Case management
Enhanced usual care
Sponsored by
Japan Foundation for Neuroscience and Mental Health
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Suicide Attempt focused on measuring Suicide Attempt

Eligibility Criteria

20 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Fujita Health University Hospital
  • National Hospital Organization, Mito Medical Center
  • Tsuchiura Kyodo Hospital
  • Tsukuba Medical Center
  • Iwate Medical University Hospital
  • Kitazato University Hospital
  • Yokohama City University Medical Center
  • Nara Medical University Hospital
  • Oita Kouseiren Tsurumi Hospital
  • Oita University Hospital
  • Kansai Medical University Takii Hospital
  • Kinki University Hospital
  • Saitama Medical University Medical Center
  • Saitama Medical University Hospital
  • Fukuoka University Hospital
  • National Hospital Organization, Osaka Medical Center
  • Nihon Medical University Hospital
  • Showa University Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Case management

Enhanced usual care

Arm Description

Case management

Enhanced usual care

Outcomes

Primary Outcome Measures

First recurrent suicide behavior (suicide attempted and completed suicide)

Secondary Outcome Measures

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

Full Information

First Posted
August 15, 2008
Last Updated
January 14, 2014
Sponsor
Japan Foundation for Neuroscience and Mental Health
Collaborators
National Center of Neurology and Psychiatry, Japan
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1. Study Identification

Unique Protocol Identification Number
NCT00736918
Brief Title
RCT of Post-Suicide Attempt Case Management (ACTION-J)
Acronym
ACTION-J
Official Title
A Randomized Controlled Multicenter Trial of Post-Suicide Attempt Case Management for the Prevention of Further Attempts in Japan (ACTION-J)
Study Type
Interventional

2. Study Status

Record Verification Date
January 2014
Overall Recruitment Status
Completed
Study Start Date
June 2006 (undefined)
Primary Completion Date
June 2011 (Actual)
Study Completion Date
October 2013 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Japan Foundation for Neuroscience and Mental Health
Collaborators
National Center of Neurology and Psychiatry, Japan

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Suicide Attempt
Keywords
Suicide Attempt

7. Study Design

Primary Purpose
Prevention
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
914 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Case management
Arm Type
Experimental
Arm Description
Case management
Arm Title
Enhanced usual care
Arm Type
Active Comparator
Arm Description
Enhanced usual care
Intervention Type
Behavioral
Intervention Name(s)
Case management
Intervention Description
Case management, Usual clinical practice and Providing paper based information for suicide prevention
Intervention Type
Other
Intervention Name(s)
Enhanced usual care
Intervention Description
Usual clinical practice and Providing paper based information for suicide prevention
Primary Outcome Measure Information:
Title
First recurrent suicide behavior (suicide attempted and completed suicide)
Time Frame
Minimum 1.5 year
Secondary Outcome Measure Information:
Title
Any cause of death
Time Frame
Minimum 1.5 year
Title
Repeated recurrent incidence of suicide attempts
Time Frame
Minimum 1.5 year
Title
Utilization or personal or social resources
Time Frame
Minimum 1.5 year
Title
Number of self-injury
Time Frame
Minimum 1.5 year
Title
Health care utilization
Time Frame
Minimum 1.5 year
Title
Physical function
Time Frame
Minimum 1.5 year
Title
Beck hopeless scale
Time Frame
Minimum 1.5 year
Title
SF-36
Time Frame
Minimum 1.5 year
Title
Adverse events
Time Frame
Minimum 1.5 year
Other Pre-specified Outcome Measures:
Title
Incidence proportion of the first episode of recurrent suicidal behaviour (attempted suicide or completed suicide)
Time Frame
at 1 month after the randomization
Title
Incidence proportion of the first episode of recurrent suicidal behaviour (attempted suicide or completed suicide)
Time Frame
at 3 months after the randomization
Title
Incidence proportion of the first episode of recurrent suicidal behaviour (attempted suicide or completed suicide)
Time Frame
at 6 months after the randomization
Title
Incidence proportion of the first episode of recurrent suicidal behaviour (attempted suicide or completed suicide)
Time Frame
at 12 months after the randomization
Title
Incidence proportion of the first episode of recurrent suicidal behaviour (attempted suicide or completed suicide)
Time Frame
at 18 months after the randomization

10. Eligibility

Sex
All
Minimum Age & Unit of Time
20 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Yoshio Hirayasu, MD,PhD
Organizational Affiliation
Yokohama City University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Fujita Health University Hospital
City
Toyoake
State/Province
Aichi
ZIP/Postal Code
470-1192
Country
Japan
Facility Name
National Hospital Organization, Mito Medical Center
City
Mito
State/Province
Ibaraki
ZIP/Postal Code
311-3198
Country
Japan
Facility Name
Tsuchiura Kyodo Hospital
City
Tsuchiura
State/Province
Ibaraki
ZIP/Postal Code
300-0053
Country
Japan
Facility Name
Tsukuba Medical Center
City
Tsukuba
State/Province
Ibaraki
ZIP/Postal Code
305-8558
Country
Japan
Facility Name
Iwate Medical University Hospital
City
Morioka
State/Province
Iwate
ZIP/Postal Code
020-0023
Country
Japan
Facility Name
Kitazato University Hospital
City
Sagamihara
State/Province
Kanagawa
ZIP/Postal Code
228-0829
Country
Japan
Facility Name
Yokohama City University Medical Center
City
Yokohama
State/Province
Kanagawa
ZIP/Postal Code
232-0024
Country
Japan
Facility Name
Nara Medical University Hospital
City
Kashihara
State/Province
Nara
ZIP/Postal Code
634-0813
Country
Japan
Facility Name
Oita Kouseiren Tsurumi Hospital
City
Beppu
State/Province
Oita
ZIP/Postal Code
874-8585
Country
Japan
Facility Name
Oita University Hospital
City
Yufu
State/Province
Oita
ZIP/Postal Code
897-5503
Country
Japan
Facility Name
Kansai Medical University Takii Hospital
City
Moriguchi
State/Province
Osaka
ZIP/Postal Code
570-0074
Country
Japan
Facility Name
Kinki University Hospital
City
Sayama
State/Province
Osaka
ZIP/Postal Code
589-0014
Country
Japan
Facility Name
Saitama Medical University Medical Center
City
Kawagoe
State/Province
Saitama
ZIP/Postal Code
350-8550
Country
Japan
Facility Name
Saitama Medical University Hospital
City
Moroyama
State/Province
Saitama
ZIP/Postal Code
350-0495
Country
Japan
Facility Name
Fukuoka University Hospital
City
Fukuoka
ZIP/Postal Code
814-0128
Country
Japan
Facility Name
National Hospital Organization, Osaka Medical Center
City
Osaka
Country
Japan
Facility Name
Nihon Medical University Hospital
City
Tokyo
ZIP/Postal Code
113-0022
Country
Japan
Facility Name
Showa University Hospital
City
Tokyo
ZIP/Postal Code
142-0064
Country
Japan

12. IPD Sharing Statement

Citations:
PubMed Identifier
19781096
Citation
Hirayasu Y, Kawanishi C, Yonemoto N, Ishizuka N, Okubo Y, Sakai A, Kishimoto T, Miyaoka H, Otsuka K, Kamijo Y, Matsuoka Y, Aruga T. A randomized controlled multicenter trial of post-suicide attempt case management for the prevention of further attempts in Japan (ACTION-J). BMC Public Health. 2009 Sep 26;9:364. doi: 10.1186/1471-2458-9-364.
Results Reference
background
PubMed Identifier
18524048
Citation
Kawanishi C, Hirayasu Y, Ariga T, Ishizuka N, Yamada M, Takahashi K. ["ACTION-J", a multi-center joint study for the development of strategies to prevent recurrence of suicidal ideation (a strategic study for anti-suicide policies supported by the Health, Labor and Welfare Ministry): its background and research outline]. Seishin Shinkeigaku Zasshi. 2008;110(3):230-7. No abstract available. Japanese.
Results Reference
background
PubMed Identifier
34332432
Citation
Inui-Yukawa M, Miyaoka H, Yamamoto K, Kamijo Y, Takai M, Yonemoto N, Kawanishi C, Otsuka K, Tachikawa H, Hirayasu Y. Effectiveness of assertive case management for patients with suicidal intent. Psychiatry Res. 2021 Oct;304:114125. doi: 10.1016/j.psychres.2021.114125. Epub 2021 Jul 19.
Results Reference
derived
PubMed Identifier
33884617
Citation
Witt KG, Hetrick SE, Rajaram G, Hazell P, Taylor Salisbury TL, Townsend E, Hawton K. Psychosocial interventions for self-harm in adults. Cochrane Database Syst Rev. 2021 Apr 22;4(4):CD013668. doi: 10.1002/14651858.CD013668.pub2.
Results Reference
derived
PubMed Identifier
32368793
Citation
Storebo OJ, Stoffers-Winterling JM, Vollm BA, Kongerslev MT, Mattivi JT, Jorgensen MS, Faltinsen E, Todorovac A, Sales CP, Callesen HE, Lieb K, Simonsen E. Psychological therapies for people with borderline personality disorder. Cochrane Database Syst Rev. 2020 May 4;5(5):CD012955. doi: 10.1002/14651858.CD012955.pub2.
Results Reference
derived
PubMed Identifier
26360731
Citation
Kawanishi C, Aruga T, Ishizuka N, Yonemoto N, Otsuka K, Kamijo Y, Okubo Y, Ikeshita K, Sakai A, Miyaoka H, Hitomi Y, Iwakuma A, Kinoshita T, Akiyoshi J, Horikawa N, Hirotsune H, Eto N, Iwata N, Kohno M, Iwanami A, Mimura M, Asada T, Hirayasu Y; ACTION-J Group. Assertive case management versus enhanced usual care for people with mental health problems who had attempted suicide and were admitted to hospital emergency departments in Japan (ACTION-J): a multicentre, randomised controlled trial. Lancet Psychiatry. 2014 Aug;1(3):193-201. doi: 10.1016/S2215-0366(14)70259-7. Epub 2014 Aug 5.
Results Reference
derived

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

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