RCT of Post-Suicide Attempt Case Management (ACTION-J) (ACTION-J)
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ClinicalTrials.gov Identifier: NCT00736918 |
Recruitment Status :
Completed
First Posted : August 18, 2008
Last Update Posted : January 16, 2014
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Condition or disease | Intervention/treatment | Phase |
---|---|---|
Suicide Attempt | Behavioral: Case management Other: Enhanced usual care | Phase 3 |
Study Type : | Interventional (Clinical Trial) |
Actual Enrollment : | 914 participants |
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) |
Study Start Date : | June 2006 |
Actual Primary Completion Date : | June 2011 |
Actual Study Completion Date : | October 2013 |
Arm | Intervention/treatment |
---|---|
Experimental: Case management
Case management
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Behavioral: Case management
Case management, Usual clinical practice and Providing paper based information for suicide prevention |
Active Comparator: Enhanced usual care
Enhanced usual care
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Other: Enhanced usual care
Usual clinical practice and Providing paper based information for suicide prevention |
- First recurrent suicide behavior (suicide attempted and completed suicide) [ Time Frame: Minimum 1.5 year ]
- 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 ]
- 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 ]

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Ages Eligible for Study: | 20 Years and older (Adult, Older Adult) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
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

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

Principal Investigator: | Yoshio Hirayasu, MD,PhD | Yokohama City University |
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 |
Other Study ID Numbers: |
J-MISP-01 C000000444 ( Registry Identifier: UMIN-CTR ) |
First Posted: | August 18, 2008 Key Record Dates |
Last Update Posted: | January 16, 2014 |
Last Verified: | January 2014 |
Suicide Attempt |
Suicide Suicide, Attempted Self-Injurious Behavior Behavioral Symptoms |