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

Sponsors and Collaborators:	Japan Foundation for Neuroscience and Mental Health National Center of Neurology and Psychiatry, Japan
Information provided by:	Japan Foundation for Neuroscience and Mental Health
ClinicalTrials.gov Identifier:	NCT00737165

Purpose

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.

Condition	Intervention
Suicide, Prevention	Behavioral: Multimodal suicide prevention program Behavioral: Suicide prevention program as usual

Study Type:	Interventional
Study Design:	Prevention, Non-Randomized, Open Label, Active Control, Parallel Assignment, Safety/Efficacy Study
Official Title:	A Community Intervention Trial of Multimodal Suicide Prevention Program in Japan (NOCOMIT-J)

Resource links provided by NLM:

MedlinePlus related topics: Child Mental Health Mental Health Suicide

U.S. FDA Resources

Further study details as provided by Japan Foundation for Neuroscience and Mental Health:

Primary Outcome Measures:

Incidence of suicide attempts (completed suicides and suicide attempts except mild case ) [ Time Frame: 3.5years ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:

Incidence of completed suicides [ Time Frame: 3.5years ] [ Designated as safety issue: Yes ]
Incidence of suicide attempts [ Time Frame: 3.5 years ] [ Designated as safety issue: Yes ]

Estimated Enrollment:	2120000
Study Start Date:	July 2006
Estimated Study Completion Date:	December 2009
Estimated Primary Completion Date:	December 2009 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
1: Experimental	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
2: Active Comparator	Behavioral: Suicide prevention program as usual Usual suicide prevention program

Arms

Assigned Interventions

1: Experimental

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

2: Active Comparator

Behavioral: Suicide prevention program as usual

Usual suicide prevention program

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.

Eligibility

Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00737165

Contacts

Contact: Yutaka Ono, MD,PhD		yutakaon@sc.itc.keio.ac.jp
Contact: Kotaro Otsuka, MD,PhD		kotaro29@df6.so-net.ne.jp

Locations

Japan
Akita region group	Recruiting
Akita, Japan
Contact: Yutaka Motohashi, MD,PhD +81-18-884-6086
Principal Investigator: Motohashi Yutaka, MD,PhD
Aomori region gruop	Recruiting
Aomori, Japan
Contact: Hiroto Iwasa, MD,PhD +81-17-787-3951
Principal Investigator: Hiroto Iwasa, MD,PhD
Minami Kyusyu region group	Recruiting
Kagoshima and Miyazaki, Japan
Contact: Yutaka Ono, MD,PhD +81-3-5363-3214
Principal Investigator: Yutaka Ono, MD,PhD
Japan, Chiba
Chiba region group	Recruiting
Ichikawa, Chiba, Japan
Contact: Yuichi Kamei, MD,PhD +81-47-372-3501
Principal Investigator: Yuichi Kamei, MD,PhD
Japan, Fukuoka
Kita-Kyusyu region group	Recruiting
Kitakyusyu, Fukuoka, Japan
Contact: Jun Nakamura, MD,PhD +81-93-691-7253
Principal Investigator: Jun Nakamura, MD,PhD
Japan, Iwate
Iwate region group	Recruiting
Morioka, Iwate, Japan
Contact: Akio Sakai, MD,PhD +81-19-651-5111
Principal Investigator: Akio Sakai, MD,PhD
Japan, Miyagi
Sendai region group	Recruiting
Sendai, Miyagi, Japan
Contact: Syuichi Awata, MD,PhD +81-22-266-7111
Principal Investigator: Syuichi Awata, MD,PhD

Sponsors and Collaborators

Japan Foundation for Neuroscience and Mental Health

National Center of Neurology and Psychiatry, Japan

Investigators

Principal Investigator:

Yutaka Ono, MD,PhD

Keio University

More Information

Additional Information:

Japanese Multimodal Intervention Trials for Suicide Prevention This link exits the ClinicalTrials.gov site

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.

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. No abstract available.

Responsible Party:	Japanese Multimodal Intervention Trials for Suicide Prevention (J-MISP) ( Japan Foundation for Neuroscience and Mental Health )
Study ID Numbers:	J-MISP-02, UMIN Trial ID:UMIN000000460
Study First Received:	August 15, 2008
Last Updated:	July 31, 2009
ClinicalTrials.gov Identifier:	NCT00737165 History of Changes
Health Authority:	Japan: Ministry of Health, Labor and Welfare

Keywords provided by Japan Foundation for Neuroscience and Mental Health:

Suicide, Prevention
Community

Study placed in the following topic categories:

Suicide
Ethanol
Behavioral Symptoms
Self-Injurious Behavior

Additional relevant MeSH terms:

Suicide
Behavioral Symptoms
Self-Injurious Behavior

ClinicalTrials.gov processed this record on September 11, 2009