Suicide AttemptPhase 3ACTION-JNCT00736918
RCT of Post-Suicide Attempt Case Management (ACTION-J)
A Phase 3 study testing Case management in people with Suicide Attempt, run by Japan Foundation for Neuroscience and Mental Health at 18 sites in Japan.
Trial summary
This study will determine the effectiveness of continuous follow-up care by case manager in preventing further suicide attempts Read more about this study
- Who is it for?
- Ages 20 years and older
- Conditions the study is for
- Suicide Attempt
- What is being tested?
- Case management
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 914 participants
- Where
- 18 sitesJapan
- Study dates
- Jun 2006to Oct 2013
- Phase
- Phase 3
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 20 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- Not suffering from Axis I disorder as a primary diagnosis
Trial locations and contacts
18 sites in 1 country.
18 sites in 1 country
Japan18 sites
Oita Kouseiren Tsurumi Hospital
Beppu, Oita Prefecture, 874-8585
Fukuoka University Hospital
Fukuoka, Fukuoka, 814-0128
Nara Medical University Hospital
Kashihara, Nara, 634-0813
Saitama Medical University Medical Center
Kawagoe, Saitama, 350-8550
National Hospital Organization, Mito Medical Center
Mito, Ibaraki, 311-3198
Kansai Medical University Takii Hospital
Moriguchi, Osaka, 570-0074
Iwate Medical University Hospital
Morioka, Iwate, 020-0023
Saitama Medical University Hospital
Morohongō, Saitama, 350-0495
National Hospital Organization, Osaka Medical Center
Osaka, Osaka
Kitazato University Hospital
Sagamihara, Kanagawa, 228-0829
Kinki University Hospital
Sayama, Osaka, 589-0014
Nihon Medical University Hospital
Tokyo, Tokyo, 113-0022
Showa University Hospital
Tokyo, Tokyo, 142-0064
Fujita Health University Hospital
Toyoake, Aichi-ken, 470-1192
Tsuchiura Kyodo Hospital
Tsuchiura, Ibaraki, 300-0053
Tsukuba Medical Center
Tsukuba, Ibaraki, 305-8558
Yokohama City University Medical Center
Yokohama, Kanagawa, 232-0024
Oita University Hospital
Yufu, Oita Prefecture, 897-5503
About this study
Official title: 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
Read the 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.
- Conditions
- Suicide Attempt
- Being tested
- Case management, Enhanced usual care
- Keywords
- Suicide Attempt
- Medical subject headings
- Suicide, Attempted
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Case managementBehavioural
Case management, Usual clinical practice and Providing paper based information for suicide prevention
Enhanced usual careOther
Usual clinical practice and Providing paper based information for suicide prevention
| Study group | Role | What they receive |
|---|---|---|
| Case management | Experimental | Case management Receives: Behavioral: Case management |
| Enhanced usual care | Active comparator | Enhanced usual care Receives: Other: Enhanced usual care |
What is being measured
The primary outcome is the main question the study is designed to answer.
First recurrent suicide behavior (suicide attempted and completed suicide)
Measured: Minimum 1.5 year
Secondary outcomes (9)
Any cause of death
Measured: Minimum 1.5 year
Repeated recurrent incidence of suicide attempts
Measured: Minimum 1.5 year
Utilization or personal or social resources
Measured: Minimum 1.5 year
Number of self-injury
Measured: Minimum 1.5 year
Health care utilization
Measured: Minimum 1.5 year
Physical function
Measured: Minimum 1.5 year
Beck hopeless scale
Measured: Minimum 1.5 year
SF-36
Measured: Minimum 1.5 year
Adverse events
Measured: Minimum 1.5 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Aug 2008 (estimated)
- Study startJun 2006
- Primary completionJun 2011
- Study completionOct 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (6)Papers the sponsor has linked to this study.
- Other trials for Suicide AttemptStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 914 participants (actual)
Sponsor and investigators
- Lead sponsor
- Japan Foundation for Neuroscience and Mental Health
- Sponsor type
- University, hospital or other
- Collaborators
- National Center of Neurology and Psychiatry, Japan
- Responsible party
- Sponsor
- Investigators
- Yoshio Hirayasu, MD,PhD, Principal investigator, Yokohama City University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00736918
- Sponsor's protocol ID
- J-MISP-01
- Other IDs
- C000000444
- Acronym
- ACTION-J
- Status last verified
- Jan 2014
- First submitted
- 15 Aug 2008
- Last updated
- 16 Jan 2014
- Results posted
- No
- Data monitoring committee
- Yes
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. doi: 10.1186/1471-2458-9-364.
PubMed 19781096Kawanishi 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.
PubMed 18524048Inui-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.
PubMed 34332432Witt 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.
PubMed 33884617Storebo 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.
PubMed 32368793Kawanishi 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.
PubMed 26360731
Study at a glance
From the registry record, last updated by the sponsor on 16 Jan 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized Controlled Multicenter Trial of Post-Suicide Attempt Case Management for the Prevention of Further Attempts in Japan (ACTION-J)
- ClinicalTrials.gov ID
- NCT00736918
- Acronym / sponsor ID
- ACTION-J / J-MISP-01
- Conditions
- Suicide Attempt
- Keywords
- Suicide Attempt
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 914 participants (actual)
- Lead sponsor
- Japan Foundation for Neuroscience and Mental HealthUniversity, hospital or other
- Collaborators
- National Center of Neurology and Psychiatry, Japan
- Study start
- Jun 2006
- Primary completion
- Jun 2011 (actual)
- Study completion
- Oct 2013 (actual)
- First posted
- 18 Aug 2008 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Case management | Experimental | Behavioral: Case managementCase management |
| Enhanced usual care | Active comparator | Other: Enhanced usual careEnhanced usual care |
Who may qualify
- Ages
- 20 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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
Key exclusion criteria (1 listed)
- Not suffering from Axis I disorder as a primary diagnosis
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Case managementCase management, Usual clinical practice and Providing paper based information for suicide prevention | Behavioural | Case management |
| Enhanced usual careUsual clinical practice and Providing paper based information for suicide prevention | Other | Enhanced usual care |
Primary outcome
First recurrent suicide behavior (suicide attempted and completed suicide)
Time frame: Minimum 1.5 year
9 secondary outcomes
Any cause of death
Time frame: Minimum 1.5 year
Repeated recurrent incidence of suicide attempts
Time frame: Minimum 1.5 year
Utilization or personal or social resources
Time frame: Minimum 1.5 year
Number of self-injury
Time frame: Minimum 1.5 year
Health care utilization
Time frame: Minimum 1.5 year
Physical function
Time frame: Minimum 1.5 year
Beck hopeless scale
Time frame: Minimum 1.5 year
SF-36
Time frame: Minimum 1.5 year
Adverse events
Time frame: Minimum 1.5 year
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Jan 2014.
- Background: PubMed 19781096Hirayasu 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.
- Background: PubMed 18524048Kawanishi 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.
- Derived from this study: PubMed 34332432Inui-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.
- Derived from this study: PubMed 33884617Witt 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.
- Derived from this study: PubMed 32368793Storebo 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.
- Derived from this study: PubMed 26360731Kawanishi 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.
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Suicide
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Yoshio Hirayasu, MD,PhD principal investigator
Yokohama City University
18 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Case management in people with Suicide Attempt, run by Japan Foundation for Neuroscience and Mental Health at 18 sites in Japan.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 16 Jan 2014. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 18 sites in Japan. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
First recurrent suicide behavior (suicide attempted and completed suicide) (time frame: Minimum 1.5 year). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00736918, which also lists 6 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 Jan 2014.