Clinical trial NCT00736918: RCT of Post-Suicide Attempt Case Management (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
Overall status: COMPLETED
Phase: PHASE3
Conditions: Suicide Attempt
Keywords: Suicide Attempt
Lead sponsor: Japan Foundation for Neuroscience and Mental Health
Sponsor class: OTHER
Collaborators: name: National Center of Neurology and Psychiatry, Japan
First posted: 2008-08-18
Enrollment: 914
Sex: ALL
Minimum age (years): 20
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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.

Eligibility criteria: 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

Primary outcomes:
measure: First recurrent suicide behavior (suicide attempted and completed suicide)
timeFrame: Minimum 1.5 year
Secondary outcomes:
measure: Any cause of death
timeFrame: Minimum 1.5 year
measure: Repeated recurrent incidence of suicide attempts
timeFrame: Minimum 1.5 year
measure: Utilization or personal or social resources
timeFrame: Minimum 1.5 year
measure: Number of self-injury
timeFrame: Minimum 1.5 year
measure: Health care utilization
timeFrame: Minimum 1.5 year
measure: Physical function
timeFrame: Minimum 1.5 year
measure: Beck hopeless scale
timeFrame: Minimum 1.5 year
measure: SF-36
timeFrame: Minimum 1.5 year
measure: Adverse events
timeFrame: Minimum 1.5 year
Other outcomes:
measure: Incidence proportion of the first episode of recurrent suicidal behaviour (attempted suicide or completed suicide)
timeFrame: at 1 month after the randomization
measure: Incidence proportion of the first episode of recurrent suicidal behaviour (attempted suicide or completed suicide)
timeFrame: at 3 months after the randomization
measure: Incidence proportion of the first episode of recurrent suicidal behaviour (attempted suicide or completed suicide)
timeFrame: at 6 months after the randomization
measure: Incidence proportion of the first episode of recurrent suicidal behaviour (attempted suicide or completed suicide)
timeFrame: at 12 months after the randomization
measure: Incidence proportion of the first episode of recurrent suicidal behaviour (attempted suicide or completed suicide)
timeFrame: at 18 months after the randomization
Locations:
city: Toyoake
country: Japan
facility: Fujita Health University Hospital
state: Aichi
city: Mito
country: Japan
facility: National Hospital Organization, Mito Medical Center
state: Ibaraki
city: Tsuchiura
country: Japan
facility: Tsuchiura Kyodo Hospital
state: Ibaraki
city: Tsukuba
country: Japan
facility: Tsukuba Medical Center
state: Ibaraki
city: Morioka
country: Japan
facility: Iwate Medical University Hospital
state: Iwate
city: Sagamihara
country: Japan
facility: Kitazato University Hospital
state: Kanagawa
city: Yokohama
country: Japan
facility: Yokohama City University Medical Center
state: Kanagawa
city: Kashihara
country: Japan
facility: Nara Medical University Hospital
state: Nara
city: Beppu
country: Japan
facility: Oita Kouseiren Tsurumi Hospital
state: Oita
city: Yufu
country: Japan
facility: Oita University Hospital
state: Oita
city: Moriguchi
country: Japan
facility: Kansai Medical University Takii Hospital
state: Osaka
city: Sayama
country: Japan
facility: Kinki University Hospital
state: Osaka
city: Kawagoe
country: Japan
facility: Saitama Medical University Medical Center
state: Saitama
city: Moroyama
country: Japan
facility: Saitama Medical University Hospital
state: Saitama
city: Fukuoka
country: Japan
facility: Fukuoka University Hospital
city: Osaka
country: Japan
facility: National Hospital Organization, Osaka Medical Center
city: Tokyo
country: Japan
facility: Nihon Medical University Hospital
city: Tokyo
country: Japan
facility: Showa University Hospital
Study officials:
affiliation: Yokohama City University
name: Yoshio Hirayasu, MD,PhD
role: PRINCIPAL_INVESTIGATOR
References:
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.
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.
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.
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.
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.
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.