RCT of Post-Suicide Attempt Case Management (ACTION-J) (ACTION-J)
This study has been completed.
Sponsor:
Japan Foundation for Neuroscience and Mental Health
ClinicalTrials.gov Identifier:
NCT00736918
First Posted: August 18, 2008
Last Update Posted: January 16, 2014
Collaborator:
National Center of Neurology and Psychiatry, Japan
Information provided by (Responsible Party):
Japan Foundation for Neuroscience and Mental Health
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Purpose
This study will determine the effectiveness of continuous follow-up care by case manager in preventing further suicide attempts
| Condition | Intervention | Phase |
|---|---|---|
| Suicide Attempt | Behavioral: Case management Other: Enhanced usual care | Phase 3 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Intervention Model: Parallel Assignment Masking: Single (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:
Further study details as provided by Japan Foundation for Neuroscience and Mental Health:
Primary Outcome Measures:
- First recurrent suicide behavior (suicide attempted and completed suicide) [ Time Frame: Minimum 1.5 year ]
Secondary Outcome Measures:
- 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 ]
Other Outcome Measures:
- Incidence proportion of the first episode of recurrent suicidal behaviour (attempted suicide or completed suicide) [ Time Frame: at 1 month after the randomization ]
- Incidence proportion of the first episode of recurrent suicidal behaviour (attempted suicide or completed suicide) [ Time Frame: at 3 months after the randomization ]
- Incidence proportion of the first episode of recurrent suicidal behaviour (attempted suicide or completed suicide) [ Time Frame: at 6 months after the randomization ]
- Incidence proportion of the first episode of recurrent suicidal behaviour (attempted suicide or completed suicide) [ Time Frame: at 12 months after the randomization ]
- Incidence proportion of the first episode of recurrent suicidal behaviour (attempted suicide or completed suicide) [ Time Frame: at 18 months after the randomization ]
| Enrollment: | 914 |
| Study Start Date: | June 2006 |
| Study Completion Date: | October 2013 |
| Primary Completion Date: | June 2011 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Experimental: Case management
Case management
|
Behavioral: Case management
Case management, Usual clinical practice and Providing paper based information for suicide prevention
|
|
Active Comparator: Enhanced usual care
Enhanced usual care
|
Other: Enhanced usual care
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
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| Ages Eligible for Study: | 20 Years and older (Adult, Senior) |
| Sexes Eligible for Study: | All |
| 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
Information from the National Library of Medicine
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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 | |
| Nihon Medical University Hospital | |
| Tokyo, Japan, 113-0022 | |
| Showa University Hospital | |
| Tokyo, Japan, 142-0064 | |
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:
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
| Responsible Party: | Japan Foundation for Neuroscience and Mental Health |
| ClinicalTrials.gov Identifier: | NCT00736918 History of Changes |
| Other Study ID Numbers: |
J-MISP-01 C000000444 ( Registry Identifier: UMIN-CTR ) |
| First Submitted: | August 15, 2008 |
| First Posted: | August 18, 2008 |
| Last Update Posted: | January 16, 2014 |
| Last Verified: | January 2014 |
Keywords provided by Japan Foundation for Neuroscience and Mental Health:
|
Suicide Attempt |
Additional relevant MeSH terms:
|
Suicide Suicide, Attempted Self-Injurious Behavior Behavioral Symptoms |