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UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000000460
Receipt No. 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

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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
Email 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
Email kotaro29@df6.so-net.ne.jp

Sponsor
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

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
Email

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
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000000560

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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