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

Suicide Attempt Clinical Trial

— 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)

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00736918
• Other study ID #: J-MISP-01
• Secondary ID: C000000444
• Status: Completed
• Phase: Phase 3
• First received: August 15, 2008
• Last updated: January 14, 2014
• Start date: June 2006
• Est. completion date: October 2013

Study information

• Verified date: January 2014
• Source: Japan Foundation for Neuroscience and Mental Health
• Contact: n/a
• Is FDA regulated: No
• Health authority: Japan: Ministry of Health, Labor and Welfare
• Study type: Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 914
• Est. completion date: October 2013
• Est. primary completion date: June 2011
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 20 Years and older

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Outcomes Assessor), Primary Purpose: Prevention

Related Conditions & MeSH terms

• Suicide
• Suicide Attempt
• Suicide, Attempted

Intervention

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

Other:
• Enhanced usual care
Usual clinical practice and Providing paper based information for suicide prevention

Locations

Country	Name	City	State
Japan	Oita Kouseiren Tsurumi Hospital	Beppu	Oita
Japan	Fukuoka University Hospital	Fukuoka
Japan	Nara Medical University Hospital	Kashihara	Nara
Japan	Saitama Medical University Medical Center	Kawagoe	Saitama
Japan	National Hospital Organization, Mito Medical Center	Mito	Ibaraki
Japan	Kansai Medical University Takii Hospital	Moriguchi	Osaka
Japan	Iwate Medical University Hospital	Morioka	Iwate
Japan	Saitama Medical University Hospital	Moroyama	Saitama
Japan	National Hospital Organization, Osaka Medical Center	Osaka
Japan	Kitazato University Hospital	Sagamihara	Kanagawa
Japan	Kinki University Hospital	Sayama	Osaka
Japan	Nihon Medical University Hospital	Tokyo
Japan	Showa University Hospital	Tokyo
Japan	Fujita Health University Hospital	Toyoake	Aichi
Japan	Tsuchiura Kyodo Hospital	Tsuchiura	Ibaraki
Japan	Tsukuba Medical Center	Tsukuba	Ibaraki
Japan	Yokohama City University Medical Center	Yokohama	Kanagawa
Japan	Oita University Hospital	Yufu	Oita

Sponsors (2)

Lead Sponsor	Collaborator
Japan Foundation for Neuroscience and Mental Health	National Center of Neurology and Psychiatry, Japan

Country where clinical trial is conducted

Japan, 

References & Publications (2)

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. — View 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. Japanese. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Incidence proportion of the first episode of recurrent suicidal behaviour (attempted suicide or completed suicide)		at 1 month after the randomization	Yes
Other	Incidence proportion of the first episode of recurrent suicidal behaviour (attempted suicide or completed suicide)		at 3 months after the randomization	Yes
Other	Incidence proportion of the first episode of recurrent suicidal behaviour (attempted suicide or completed suicide)		at 6 months after the randomization	Yes
Other	Incidence proportion of the first episode of recurrent suicidal behaviour (attempted suicide or completed suicide)		at 12 months after the randomization	Yes
Other	Incidence proportion of the first episode of recurrent suicidal behaviour (attempted suicide or completed suicide)		at 18 months after the randomization	Yes
Primary	First recurrent suicide behavior (suicide attempted and completed suicide)		Minimum 1.5 year	Yes
Secondary	Any cause of death		Minimum 1.5 year	Yes
Secondary	Repeated recurrent incidence of suicide attempts		Minimum 1.5 year	Yes
Secondary	Utilization or personal or social resources		Minimum 1.5 year	No
Secondary	Number of self-injury		Minimum 1.5 year	Yes
Secondary	Health care utilization		Minimum 1.5 year	No
Secondary	Physical function		Minimum 1.5 year	Yes
Secondary	Beck hopeless scale		Minimum 1.5 year	No
Secondary	SF-36		Minimum 1.5 year	No
Secondary	Adverse events		Minimum 1.5 year	Yes