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

NCT ID: NCT00736918

Last Updated: 2014-01-16

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE3

Total Enrollment

914 participants

Study Classification

INTERVENTIONAL

Study Start Date

2006-06-30

Study Completion Date

2013-10-31

Brief Summary

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

Detailed Description

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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.

Conditions

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Suicide Attempt

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

SINGLE

Outcome Assessors

Study Groups

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Case management

Case management

Group Type EXPERIMENTAL

Case management

Intervention Type BEHAVIORAL

Case management, Usual clinical practice and Providing paper based information for suicide prevention

Enhanced usual care

Enhanced usual care

Group Type ACTIVE_COMPARATOR

Enhanced usual care

Intervention Type OTHER

Usual clinical practice and Providing paper based information for suicide prevention

Interventions

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Case management

Case management, Usual clinical practice and Providing paper based information for suicide prevention

Intervention Type BEHAVIORAL

Enhanced usual care

Usual clinical practice and Providing paper based information for suicide prevention

Intervention Type OTHER

Eligibility Criteria

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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
Minimum Eligible Age

20 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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National Center of Neurology and Psychiatry, Japan

OTHER

Sponsor Role collaborator

Japan Foundation for Neuroscience and Mental Health

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Yoshio Hirayasu, MD,PhD

Role: PRINCIPAL_INVESTIGATOR

Yokohama City University

Locations

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Fujita Health University Hospital

Toyoake, Aichi-ken, Japan

Site Status

Fukuoka University Hospital

Fukuoka, Fukuoka, Japan

Site Status

National Hospital Organization, Mito Medical Center

Mito, Ibaraki, Japan

Site Status

Tsuchiura Kyodo Hospital

Tsuchiura, Ibaraki, Japan

Site Status

Tsukuba Medical Center

Tsukuba, Ibaraki, Japan

Site Status

Iwate Medical University Hospital

Morioka, Iwate, Japan

Site Status

Kitazato University Hospital

Sagamihara, Kanagawa, Japan

Site Status

Yokohama City University Medical Center

Yokohama, Kanagawa, Japan

Site Status

Nara Medical University Hospital

Kashihara, Nara, Japan

Site Status

Oita Kouseiren Tsurumi Hospital

Beppu, Oita Prefecture, Japan

Site Status

Oita University Hospital

Yufu, Oita Prefecture, Japan

Site Status

Kansai Medical University Takii Hospital

Moriguchi, Osaka, Japan

Site Status

National Hospital Organization, Osaka Medical Center

Osaka, Osaka, Japan

Site Status

Kinki University Hospital

Sayama, Osaka, Japan

Site Status

Saitama Medical University Medical Center

Kawagoe, Saitama, Japan

Site Status

Saitama Medical University Hospital

Morohongō, Saitama, Japan

Site Status

Nihon Medical University Hospital

Tokyo, Tokyo, Japan

Site Status

Showa University Hospital

Tokyo, Tokyo, Japan

Site Status

Countries

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Japan

References

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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.

Reference Type BACKGROUND
PMID: 19781096 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 18524048 (View on PubMed)

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.

Reference Type DERIVED
PMID: 34332432 (View on PubMed)

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.

Reference Type DERIVED
PMID: 33884617 (View on PubMed)

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.

Reference Type DERIVED
PMID: 32368793 (View on PubMed)

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.

Reference Type DERIVED
PMID: 26360731 (View on PubMed)

Other Identifiers

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C000000444

Identifier Type: REGISTRY

Identifier Source: secondary_id

J-MISP-01

Identifier Type: -

Identifier Source: org_study_id

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