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

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ClinicalTrials.gov Identifier: NCT00736918

Recruitment Status : Completed

First Posted : August 18, 2008

Last Update Posted : January 16, 2014

Sponsor:

Collaborator:

National Center of Neurology and Psychiatry, Japan

Information provided by (Responsible Party):

Japan Foundation for Neuroscience and Mental Health

Study Description

Brief Summary:

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

Condition or disease	Intervention/treatment	Phase
Suicide Attempt	Behavioral: Case management Other: Enhanced usual care	Phase 3

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.

Study Design

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Study Type :	Interventional (Clinical Trial)
Actual Enrollment :	914 participants
Allocation:	Randomized
Intervention Model:	Parallel Assignment
Masking:	Single (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)
Study Start Date :	June 2006
Actual Primary Completion Date :	June 2011
Actual Study Completion Date :	October 2013

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Suicide

U.S. FDA Resources

Arms and Interventions

Arm	Intervention/treatment
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

Outcome Measures

Primary Outcome Measures :

First recurrent suicide behavior (suicide attempted and completed suicide) [ Time Frame: Minimum 1.5 year ]

Secondary Outcome Measures :

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 ]

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 ]
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 ]

Eligibility Criteria

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Ages Eligible for Study:	20 Years and older (Adult, Older Adult)
Sexes Eligible for Study:	All
Accepts Healthy Volunteers:	No

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

Contacts and Locations

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00736918

Locations

Show 18 study locations

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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
Nihon Medical University Hospital
Tokyo, Japan, 113-0022
Showa University Hospital
Tokyo, Japan, 142-0064

Sponsors and Collaborators

Japan Foundation for Neuroscience and Mental Health

National Center of Neurology and Psychiatry, Japan

Investigators

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Principal Investigator:	Yoshio Hirayasu, MD,PhD	Yokohama City University

More Information

Publications:

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.

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. Japanese.

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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. Review.

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:CD013668. doi: 10.1002/14651858.CD013668.pub2.

Storebø OJ, Stoffers-Winterling JM, Völlm BA, Kongerslev MT, Mattivi JT, Jørgensen 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:CD012955. doi: 10.1002/14651858.CD012955.pub2.

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.

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Responsible Party:	Japan Foundation for Neuroscience and Mental Health
ClinicalTrials.gov Identifier:	NCT00736918
Other Study ID Numbers:	J-MISP-01 C000000444 ( Registry Identifier: UMIN-CTR )
First Posted:	August 18, 2008 Key Record Dates
Last Update Posted:	January 16, 2014
Last Verified:	January 2014

Keywords provided by Japan Foundation for Neuroscience and Mental Health:


Suicide Attempt

Additional relevant MeSH terms:

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Suicide Suicide, Attempted Self-Injurious Behavior Behavioral Symptoms

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