- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00737165
A Community Intervention Trial of Multimodal Suicide Prevention Program in Japan (NOCOMIT-J) (NOCOMIT-J)
October 30, 2013 updated by: Japan Foundation for Neuroscience and Mental Health
- The primary goal for this study is to examine the effectiveness of community-based multimodal intervention program for suicide prevention in relatively high suicide rate region compared to control region.
- The secondary goal for this study is to explore the effectiveness of community-based multimodal intervention program for suicide prevention in the highly populated regions. In addition, we examine the effectiveness of the prevention program in the all regions combined.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Detailed Description
Suicide is a major public health problem and the number of suicide victims has exceeded 30,000 a year since 1998 in Japan.
Suicide rate is almost 25/100,000, which are remarkably high numbers among advanced countries.
To examine the effectiveness of community-based multimodal intervention program for suicide prevention, a trial by J-MISP (Japanese Multimodal Intervention Trials for Suicide Prevention).
This research project is one of the strategic research projects funded by The Japanese Ministry of Health, Labor and Welfare.
Study Type
Interventional
Enrollment (Actual)
1951060
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
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-
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Akita, Japan
- Akita region group
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Aomori, Japan
- Aomori region gruop
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Kagoshima and Miyazaki, Japan
- Minami Kyusyu region group
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Chiba
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Ichikawa, Chiba, Japan
- Chiba region group
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Fukuoka
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Kitakyusyu, Fukuoka, Japan
- Kita-Kyusyu region group
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Iwate
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Morioka, Iwate, Japan
- Iwate region group
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Miyagi
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Sendai, Miyagi, Japan
- Sendai region group
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
- Child
- Adult
- Older Adult
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
Inclusion Criteria:
Areas which meet the following criteria are eligible for this study;
- An area with firm support from local government and other organizations to conduct this multimodal suicide prevention program
- An area capable to select intervention and control regions
- An area capable to follow the data collection procedure described in the protocol
- An area with comparable baseline data on suicide attempts rate in intervention and control region
- An area with comparable baseline data on demographics in intervention and control region
Exclusion Criteria:
- None
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Prevention
- Allocation: Non-Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Multimodal community intervention
Multimodal suicide prevention program
|
A community intervention of multimodal suicide prevention program includes following components:
|
Active Comparator: Community intervention as usual
Suicide prevention program as usual
|
Usual suicide prevention program
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Incidence of suicide attempts (completed suicides and suicide attempts except mild case )
Time Frame: 3.5years
|
3.5years
|
Secondary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Incidence of completed suicides
Time Frame: 3.5years
|
3.5years
|
Incidence of suicide attempts
Time Frame: 3.5 years
|
3.5 years
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Collaborators
Investigators
- Principal Investigator: Yutaka Ono, MD,PhD, Keio University
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
General Publications
- Ono Y, Awata S, Iida H, Ishida Y, Ishizuka N, Iwasa H, Kamei Y, Motohashi Y, Nakagawa A, Nakamura J, Nishi N, Otsuka K, Oyama H, Sakai A, Sakai H, Suzuki Y, Tajima M, Tanaka E, Uda H, Yonemoto N, Yotsumoto T, Watanabe N. A community intervention trial of multimodal suicide prevention program in Japan: a novel multimodal community intervention program to prevent suicide and suicide attempt in Japan, NOCOMIT-J. BMC Public Health. 2008 Sep 15;8:315. doi: 10.1186/1471-2458-8-315.
- Ono H, Awada S, Iida H, Ishida Y, Ishizuka N, Iwasa H, Kamei Y, Motohashi Y, Nakagawa A, Nakamura J, Nishi N, Otsuka K, Oyama H, Sakai A, Sakai H, Suzuki Y, Tajima M, Tanaka E, Uda E, Yonemoto N, Watanabe N. [Importance of area activities to prevent suicide and the involvement of NOCOMIT-J]. Seishin Shinkeigaku Zasshi. 2008;110(3):216-21. No abstract available. Japanese.
- Ono Y, Sakai A, Otsuka K, Uda H, Oyama H, Ishizuka N, Awata S, Ishida Y, Iwasa H, Kamei Y, Motohashi Y, Nakamura J, Nishi N, Watanabe N, Yotsumoto T, Nakagawa A, Suzuki Y, Tajima M, Tanaka E, Sakai H, Yonemoto N. Effectiveness of a multimodal community intervention program to prevent suicide and suicide attempts: a quasi-experimental study. PLoS One. 2013 Oct 9;8(10):e74902. doi: 10.1371/journal.pone.0074902. eCollection 2013.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
July 1, 2006
Primary Completion (Actual)
December 1, 2009
Study Completion (Actual)
March 1, 2011
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)
October 31, 2013
Last Update Submitted That Met QC Criteria
October 30, 2013
Last Verified
October 1, 2013
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- J-MISP-02
- UMIN000000460 (Registry Identifier: UMIN-CTR)
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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