A Randomized Controlled Multicenter Trial of Post-Suicide Attempt Case Management for the Prevention of Further Attempts in Japan (ACTION-J) - Full Text View

Purpose

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

Condition	Intervention	Phase
Post-Suicide Attempt	Behavioral: Case management Other: Treatment as usual	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:

MedlinePlus related topics: Suicide

U.S. FDA Resources

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

Primary Outcome Measures:

Recurrent incidence rates of suicide attempts [ 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 ]
Number and rates of 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 ]

Estimated Enrollment:	842
Study Start Date:	June 2006
Estimated Study Completion Date:	December 2011
Primary Completion Date:	June 2011 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Experimental: 1	Behavioral: Case management Case management, Usual clinical practice and Providing paper based information for suicide prevention
Active Comparator: 2	Other: Treatment as usual 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:

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

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:

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.

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. No abstract available.

Responsible Party:	Japan Foundation for Neuroscience and Mental Health,, Japanese Multimodal Intervention Trials for Suicide Prevention (J-MISP), Administration office
ClinicalTrials.gov Identifier:	NCT00736918 History of Changes
Other Study ID Numbers:	J-MISP-01, UMIN Trial ID: C000000444
Study First Received:	August 15, 2008
Last Updated:	July 24, 2011
Health Authority:	Japan: Ministry of Health, Labor and Welfare

Keywords provided by Japan Foundation for Neuroscience and Mental Health:

Suicide attempts

Additional relevant MeSH terms:

Suicide
Suicide, Attempted
Self-Injurious Behavior
Behavioral Symptoms

ClinicalTrials.gov processed this record on May 23, 2013