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

This study has been completed.
Sponsor:
Collaborator:
National Center of Neurology and Psychiatry, Japan
Information provided by:
Japan Foundation for Neuroscience and Mental Health
ClinicalTrials.gov Identifier:
NCT00737165
First received: August 15, 2008
Last updated: July 24, 2011
Last verified: July 2011
History of Changes
  Purpose
  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.

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

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Prevention
Official Title: A Community Intervention Trial of Multimodal Suicide Prevention Program in Japan (NOCOMIT-J)

Resource links provided by NLM:

MedlinePlus related topics: 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
Study Completion Date: March 2011
Primary Completion Date: December 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 1 Behavioral: Multimodal suicide prevention program

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
Active Comparator: 2 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

Locations
Japan
Chiba region group
Ichikawa, Chiba, Japan
Kita-Kyusyu region group
Kitakyusyu, Fukuoka, Japan
Iwate region group
Morioka, Iwate, Japan
Sendai region group
Sendai, Miyagi, Japan
Akita region group
Akita, Japan
Aomori region gruop
Aomori, Japan
Minami Kyusyu region group
Kagoshima and Miyazaki, Japan
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

Publications:

Responsible Party: Japan Foundation for Neuroscience and Mental Health, Japanese Multimodal Intervention Trials for Suicide Prevention (J-MISP)
ClinicalTrials.gov Identifier: NCT00737165     History of Changes
Other Study ID Numbers: J-MISP-02, UMIN Trial ID:UMIN000000460
Study First Received: August 15, 2008
Last Updated: July 24, 2011
Health Authority: Japan: Ministry of Health, Labor and Welfare

Keywords provided by Japan Foundation for Neuroscience and Mental Health:
Suicide, Prevention
Community

Additional relevant MeSH terms:
Suicide
Self-Injurious Behavior
Behavioral Symptoms

ClinicalTrials.gov processed this record on May 19, 2013