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

NCT00736918 | Completed Phase 3 DMC

• 2 other identifiers: J-MISP-01C000000444
• Study Type: interventional
• Target: 914
• Locations: 1 country
• Sites: 18

Brief Summary

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

Conditions

Suicide Attempt

Keywords

Suicide Attempt

Outcome Measures

Primary Outcomes (1)

• First recurrent suicide behavior (suicide attempted and completed suicide)

  Minimum 1.5 year

Secondary Outcomes (9)

• 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

Other Outcomes (5)

• 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

Study Arms (2)

Case management

EXPERIMENTAL

Case management

Behavioral: Case management

Enhanced usual care

ACTIVE COMPARATOR

Enhanced usual care

Other: Enhanced usual care

Interventions

Case management BEHAVIORAL

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

Case management

Enhanced usual care OTHER

Usual clinical practice and Providing paper based information for suicide prevention

Enhanced usual care

Eligibility Criteria

• Age: 20 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• Not suffering from Axis I disorder as a primary diagnosis

Sponsors & Collaborators

• Japan Foundation for Neuroscience and Mental Health: lead
• National Center of Neurology and Psychiatry, Japan: collaborator

Study Sites (18)

Fujita Health University Hospital

Toyoake, Aichi-ken, 470-1192, Japan

Location

Fukuoka University Hospital

Fukuoka, Fukuoka, 814-0128, Japan

Location

National Hospital Organization, Mito Medical Center

Mito, Ibaraki, 311-3198, Japan

Location

Tsuchiura Kyodo Hospital

Tsuchiura, Ibaraki, 300-0053, Japan

Location

Tsukuba Medical Center

Tsukuba, Ibaraki, 305-8558, Japan

Location

Iwate Medical University Hospital

Morioka, Iwate, 020-0023, Japan

Location

Kitazato University Hospital

Sagamihara, Kanagawa, 228-0829, Japan

Location

Yokohama City University Medical Center

Yokohama, Kanagawa, 232-0024, Japan

Location

Nara Medical University Hospital

Kashihara, Nara, 634-0813, Japan

Location

Oita Kouseiren Tsurumi Hospital

Beppu, Oita Prefecture, 874-8585, Japan

Location

Oita University Hospital

Yufu, Oita Prefecture, 897-5503, Japan

Location

Kansai Medical University Takii Hospital

Moriguchi, Osaka, 570-0074, Japan

Location

National Hospital Organization, Osaka Medical Center

Osaka, Osaka, Japan

Location

Kinki University Hospital

Sayama, Osaka, 589-0014, Japan

Location

Saitama Medical University Medical Center

Kawagoe, Saitama, 350-8550, Japan

Location

Saitama Medical University Hospital

Morohongō, Saitama, 350-0495, Japan

Location

Nihon Medical University Hospital

Tokyo, Tokyo, 113-0022, Japan

Location

Showa University Hospital

Tokyo, Tokyo, 142-0064, Japan

Location

Related Publications (6)

• 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.

  PMID: 19781096 BACKGROUND

• 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.

  PMID: 18524048 BACKGROUND

• 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.

  PMID: 34332432 DERIVED

• 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.

  PMID: 33884617 DERIVED

• 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.

  PMID: 32368793 DERIVED

• 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.

  PMID: 26360731 DERIVED

MeSH Terms

Conditions

Suicide, Attempted

Interventions

Case Management

Condition Hierarchy (Ancestors)

Suicide; Self-Injurious Behavior; Behavioral Symptoms; Behavior

Intervention Hierarchy (Ancestors)

Patient Care Planning; Comprehensive Health Care; Patient Care Management; Health Services Administration

Study Officials

• Yoshio Hirayasu, MD,PhD

  Yokohama City University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 15, 2008
• First Posted: August 18, 2008
• Study Start: June 1, 2006
• Primary Completion: June 1, 2011
• Study Completion: October 1, 2013
• Last Updated: January 16, 2014

Record last verified: 2014-01

Locations

JP (18)