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

Suicide Clinical Trial

— NOCOMIT-J  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00737165
• Other study ID #: J-MISP-02
• Secondary ID: UMIN000000460
• Status: Completed
• Phase: N/A
• First received: August 15, 2008
• Last updated: October 30, 2013
• Start date: July 2006
• Est. completion date: March 2011

Study information

• Verified date: October 2013
• Source: Japan Foundation for Neuroscience and Mental Health
• Contact: n/a
• Is FDA regulated: No
• Health authority: Japan: Ministry of Health, Labor and Welfare
• Study type: Interventional

Clinical Trial Summary

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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 1951060
• Est. completion date: March 2011
• Est. primary completion date: December 2009
• Accepts healthy volunteers: No
• Gender: Both
• Age group: N/A and older

Eligibility

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:

Study Design

Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Prevention

Related Conditions & MeSH terms

• Suicide

Intervention

Behavioral:
• Multimodal suicide prevention program
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
• Suicide prevention program as usual
Usual suicide prevention program

Locations

Country	Name	City	State
Japan	Akita region group	Akita
Japan	Aomori region gruop	Aomori
Japan	Chiba region group	Ichikawa	Chiba
Japan	Minami Kyusyu region group	Kagoshima and Miyazaki
Japan	Kita-Kyusyu region group	Kitakyusyu	Fukuoka
Japan	Iwate region group	Morioka	Iwate
Japan	Sendai region group	Sendai	Miyagi

Sponsors (2)

Lead Sponsor	Collaborator
Japan Foundation for Neuroscience and Mental Health	National Center of Neurology and Psychiatry, Japan

Country where clinical trial is conducted

Japan, 

References & Publications (3)

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. Japanese. — View 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. — View 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 in — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Incidence of suicide attempts (completed suicides and suicide attempts except mild case )		3.5years	Yes
Secondary	Incidence of completed suicides		3.5years	Yes
Secondary	Incidence of suicide attempts		3.5 years	Yes