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A Community Intervention Trial of Multimodal Suicide Prevention Program in Japan (NOCOMIT-J) (NOCOMIT-J)

Primary Purpose

Suicide

Status

Completed

Phase

Not Applicable

Locations

Japan

Study Type

Interventional

Intervention

Multimodal suicide prevention program

Suicide prevention program as usual

About this trial

This is an interventional prevention trial for Suicide focused on measuring Suicide, Prevention, Community

Eligibility Criteria

undefined - undefined (Child, Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

Chiba region group
Kita-Kyusyu region group
Iwate region group
Sendai region group
Akita region group
Aomori region gruop
Minami Kyusyu region group

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Multimodal community intervention

Community intervention as usual

Arm Description

Multimodal suicide prevention program

Suicide prevention program as usual

Outcomes

Primary Outcome Measures

Incidence of suicide attempts (completed suicides and suicide attempts except mild case )

Secondary Outcome Measures

Incidence of completed suicides

Incidence of suicide attempts

Full Information

NCT ID

NCT00737165

First Posted

August 15, 2008

Last Updated

October 30, 2013

Sponsor

Japan Foundation for Neuroscience and Mental Health

Collaborators

National Center of Neurology and Psychiatry, Japan

1. Study Identification

Unique Protocol Identification Number

NCT00737165

Brief Title

A Community Intervention Trial of Multimodal Suicide Prevention Program in Japan (NOCOMIT-J)

Acronym

NOCOMIT-J

Official Title

A Community Intervention Trial of Multimodal Suicide Prevention Program in Japan (NOCOMIT-J)

Study Type

Interventional

2. Study Status

Record Verification Date

October 2013

Overall Recruitment Status

Completed

Study Start Date

July 2006 (undefined)

Primary Completion Date

December 2009 (Actual)

Study Completion Date

March 2011 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Japan Foundation for Neuroscience and Mental Health

Collaborators

National Center of Neurology and Psychiatry, Japan

4. Oversight

Data Monitoring Committee

Yes

5. Study Description

Brief Summary

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.

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Suicide

Keywords

Suicide, Prevention, Community

7. Study Design

Primary Purpose

Prevention

Study Phase

Not Applicable

Interventional Study Model

Parallel Assignment

Masking

None (Open Label)

Allocation

Non-Randomized

Enrollment

1951060 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Multimodal community intervention

Arm Type

Experimental

Arm Description

Multimodal suicide prevention program

Arm Title

Community intervention as usual

Arm Type

Active Comparator

Arm Description

Suicide prevention program as usual

Intervention Type

Behavioral

Intervention Name(s)

Multimodal suicide prevention program

Intervention Description

A community intervention of multimodal suicide prevention program includes following components: Building support networks for suicide prevention and mental health promotion in public health system Primary prevention of suicide and suicide related behaviors Secondary prevention of suicide and suicide related behaviors Tertiary prevention; after care for suicide survivors Suicide prevention targeting for people with substance/alcohol- related disorders , schizophrenia and other mental health disorders Suicide prevention targeting for people with work-related problems

Intervention Type

Behavioral

Intervention Name(s)

Suicide prevention program as usual

Intervention Description

Usual suicide prevention program

Primary Outcome Measure Information:

Title

Incidence of suicide attempts (completed suicides and suicide attempts except mild case )

Time Frame

3.5years

Secondary Outcome Measure Information:

Title

Incidence of completed suicides

Time Frame

3.5years

Title

Incidence of suicide attempts

Time Frame

3.5 years

10. Eligibility

Sex

All

Accepts Healthy Volunteers

Eligibility Criteria

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

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Yutaka Ono, MD,PhD

Organizational Affiliation

Keio University

Official's Role

Principal Investigator

Facility Information:

Facility Name

Chiba region group

City

Ichikawa

State/Province

Chiba

Country

Japan

Facility Name

Kita-Kyusyu region group

City

Kitakyusyu

State/Province

Fukuoka

Country

Japan

Facility Name

Iwate region group

City

Morioka

State/Province

Iwate

Country

Japan

Facility Name

Sendai region group

City

Sendai

State/Province

Miyagi

Country

Japan

Facility Name

Akita region group

City

Akita

Country

Japan

Facility Name

Aomori region gruop

City

Aomori

Country

Japan

Facility Name

Minami Kyusyu region group

City

Kagoshima and Miyazaki

Country

Japan

12. IPD Sharing Statement

Citations:

PubMed Identifier

18793423

Citation

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.

Results Reference

background

PubMed Identifier

18524043

Citation

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.

Results Reference

background

PubMed Identifier

24130673

Citation

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.

Results Reference

result

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A Community Intervention Trial of Multimodal Suicide Prevention Program in Japan (NOCOMIT-J)

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