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

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

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

Study Overview

• Status: Completed
• Conditions: Suicide Attempt
• Intervention / Treatment: Behavioral: Case management; Other: Enhanced usual care

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 Type: Interventional
• Enrollment (Actual): 914
• Phase: Phase 3

Contacts and Locations

Study Locations

• Japan
  • Fukuoka, Japan, 814-0128
    • Fukuoka University Hospital
  • Osaka, Japan
    • National Hospital Organization, Osaka Medical Center
  • Tokyo, Japan, 113-0022
    • Nihon Medical University Hospital
  • Tokyo, Japan, 142-0064
    • Showa University Hospital
  • Aichi
    • Toyoake, Aichi, Japan, 470-1192
      • Fujita Health University Hospital
  • Ibaraki
    • Mito, Ibaraki, Japan, 311-3198
      • National Hospital Organization, Mito Medical Center
    • Tsuchiura, Ibaraki, Japan, 300-0053
      • Tsuchiura Kyodo Hospital
    • Tsukuba, Ibaraki, Japan, 305-8558
      • Tsukuba Medical Center
  • Iwate
    • Morioka, Iwate, Japan, 020-0023
      • Iwate Medical University Hospital
  • Kanagawa
    • Sagamihara, Kanagawa, Japan, 228-0829
      • Kitazato University Hospital
    • Yokohama, Kanagawa, Japan, 232-0024
      • Yokohama City University Medical Center
  • Nara
    • Kashihara, Nara, Japan, 634-0813
      • Nara Medical University Hospital
  • Oita
    • Beppu, Oita, Japan, 874-8585
      • Oita Kouseiren Tsurumi Hospital
    • Yufu, Oita, Japan, 897-5503
      • Oita University Hospital
  • Osaka
    • Moriguchi, Osaka, Japan, 570-0074
      • Kansai Medical University Takii Hospital
    • Sayama, Osaka, Japan, 589-0014
      • Kinki University Hospital
  • Saitama
    • Kawagoe, Saitama, Japan, 350-8550
      • Saitama Medical University Medical Center
    • Moroyama, Saitama, Japan, 350-0495
      • Saitama Medical University Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 20 years and older (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: PREVENTION
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: SINGLE

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
EXPERIMENTAL: Case management	Behavioral: Case management; Case management, Usual clinical practice and Providing paper based information for suicide prevention
ACTIVE_COMPARATOR: Enhanced usual care	Other: Enhanced usual care; Usual clinical practice and Providing paper based information for suicide prevention

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
First recurrent suicide behavior (suicide attempted and completed suicide)	Minimum 1.5 year

Secondary Outcome Measures

Outcome Measure	Time Frame
Any cause of death	Minimum 1.5 year
Repeated recurrent incidence of suicide attempts	Minimum 1.5 year
Utilization or personal or social resources	Minimum 1.5 year
Number of self-injury	Minimum 1.5 year
Health care utilization	Minimum 1.5 year
Physical function	Minimum 1.5 year
Beck hopeless scale	Minimum 1.5 year
SF-36	Minimum 1.5 year
Adverse events	Minimum 1.5 year

Other Outcome Measures

Outcome Measure	Time Frame
Incidence proportion of the first episode of recurrent suicidal behaviour (attempted suicide or completed suicide)	at 1 month after the randomization
Incidence proportion of the first episode of recurrent suicidal behaviour (attempted suicide or completed suicide)	at 3 months after the randomization
Incidence proportion of the first episode of recurrent suicidal behaviour (attempted suicide or completed suicide)	at 6 months after the randomization
Incidence proportion of the first episode of recurrent suicidal behaviour (attempted suicide or completed suicide)	at 12 months after the randomization
Incidence proportion of the first episode of recurrent suicidal behaviour (attempted suicide or completed suicide)	at 18 months after the randomization

Collaborators and Investigators

• Sponsor: Japan Foundation for Neuroscience and Mental Health
• Collaborators: National Center of Neurology and Psychiatry, Japan
• Investigators: Principal Investigator: Yoshio Hirayasu, MD,PhD, Yokohama City University

Publications and helpful links

General Publications

• 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.
• 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.
• 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. No abstract available. Japanese.
• 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.
• 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.

Study record dates

Study Major Dates

• Study Start: June 1, 2006
• Primary Completion (ACTUAL): June 1, 2011
• Study Completion (ACTUAL): October 1, 2013

Study Registration Dates

• First Submitted: August 15, 2008
• First Submitted That Met QC Criteria: August 15, 2008
• First Posted (ESTIMATE): August 18, 2008

Study Record Updates

• Last Update Posted (ESTIMATE): January 16, 2014
• Last Update Submitted That Met QC Criteria: January 14, 2014
• Last Verified: January 1, 2014

More Information

Terms related to this study

• Keywords: Suicide Attempt
• Additional Relevant MeSH Terms: Behavioral Symptoms; Self-Injurious Behavior; Suicide; Suicide, Attempted
• Other Study ID Numbers: J-MISP-01; C000000444 (REGISTRY: UMIN-CTR)