UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000000460 |
|---|---|
| Receipt number | R000000560 |
| Scientific Title | A community intervention trial of multimodal suicide prevention program in Japan (NOCOMIT-J) |
| Date of disclosure of the study information | 2006/08/01 |
| Last modified on | 2013/10/30 16:28:17 |
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Basic information
Public title
A community intervention trial of multimodal suicide prevention program in Japan (NOCOMIT-J)
Acronym
A community intervention trial of multimodal suicide prevention program in Japan (NOCOMIT-J)
Scientific Title
A community intervention trial of multimodal suicide prevention program in Japan (NOCOMIT-J)
Scientific Title:Acronym
A community intervention trial of multimodal suicide prevention program in Japan (NOCOMIT-J)
Region
| Japan |
Condition
Condition
suicide attempts
Classification by specialty
| Psychiatry | Not applicable |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
(1)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.
(2)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.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Exploratory
Trial characteristics_2
Pragmatic
Developmental phase
Not applicable
Assessment
Primary outcomes
Incidence of suicide attempts (completed suicides and suicide attempts except mild case )
Key secondary outcomes
(1) Incidence of completed suicides
(2) Incidence of suicide attempts
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Active
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
2
Purpose of intervention
Prevention
Type of intervention
| Behavior,custom |
Interventions/Control_1
A community intervention of multimodal suicide prevention program includes following components:
(1)Building support networks for suicide prevention and mental health promotion in public health system
(2)Primary prevention of suicide and suicide related behaviors
(3)Secondary prevention of suicide and suicide related behaviors
(4)Tertiary prevention; after care for suicide survivors
(5)Suicide prevention targeting for people with substance/alcohol- related disorders , schizophrenia and other mental health disorders
(6)Suicide prevention targeting for people with work-related problems
Interventions/Control_2
Usual suicide prevention program
Interventions/Control_3
Interventions/Control_4
Interventions/Control_5
Interventions/Control_6
Interventions/Control_7
Interventions/Control_8
Interventions/Control_9
Interventions/Control_10
Eligibility
Age-lower limit
| Not applicable |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key 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
Key exclusion criteria
None
Target sample size
2120000
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Yutaka Ono |
Organization
Keio University
Division name
Health Center
Zip code
Address
35 Shinanomachi, Shinnjyuku, Tokyo Japan
TEL
042-341-2711
yutakaon@gmail.com
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Kotaro Otsuka |
Organization
Iwate Medical University
Division name
Department of Neuropsychiatry
Zip code
Address
19-1 Uchimaru, Morioka, Iwate Japan
TEL
042-341-2711
Homepage URL
http://www.jfnm.or.jp/itaku/J-MISP/index.html
kotaro29@df6.so-net.ne.jp
Sponsor or person
Institute
Health Labour Sciences Research Grant Research on Psychiatric and Neurological Diseases and Mental Health Japanese Multimodal Intervention Trials for Suicide Prevention (J-MISP)
Institute
Department
Personal name
Funding Source
Organization
Health Labour Sciences Research Grant Research on Psychiatric and Neurological Diseases and Mental Health
Organization
Division
Category of Funding Organization
Nationality of Funding Organization
Other related organizations
Co-sponsor
Japan foundation for neuroscience and mental health
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Address
Tel
Secondary IDs
Secondary IDs
YES
Study ID_1
NCT00737165
Org. issuing International ID_1
Clinical.gov
Study ID_2
Org. issuing International ID_2
IND to MHLW
Institutions
Institutions
Other administrative information
Date of disclosure of the study information
| 2006 | Year | 08 | Month | 01 | Day |
Related information
URL releasing protocol
http://www.ncbi.nlm.nih.gov/pubmed/18793423
Publication of results
Published
Result
URL related to results and publications
http://www.ncbi.nlm.nih.gov/pubmed/24130673
Number of participants that the trial has enrolled
Results
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
Results date posted
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
Participant flow
Adverse events
Outcome measures
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
Completed
Date of protocol fixation
| 2006 | Year | 07 | Month | 10 | Day |
Date of IRB
Anticipated trial start date
| 2006 | Year | 07 | Month | 01 | Day |
Last follow-up date
| 2009 | Year | 12 | Month | 01 | Day |
Date of closure to data entry
| 2010 | Year | 09 | Month | 01 | Day |
Date trial data considered complete
| 2010 | Year | 12 | Month | 01 | Day |
Date analysis concluded
| 2011 | Year | 03 | Month | 01 | Day |
Other
Other related information
Management information
Registered date
| 2006 | Year | 08 | Month | 01 | Day |
Last modified on
| 2013 | Year | 10 | Month | 30 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000000560
| Research Plan | |
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| Registered date | File name |
| Research case data specifications | |
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| Registered date | File name |
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