SuicideNOCOMIT-JNCT00737165
A Community Intervention Trial of Multimodal Suicide Prevention Program in Japan (NOCOMIT-J)
A study testing Multimodal suicide prevention program and Suicide prevention program as usual in people with Suicide, run by Japan Foundation for Neuroscience and Mental Health at 7 sites in Japan.
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. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Suicide
- What is being tested?
- Multimodal suicide prevention program and Suicide prevention program as usual
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 1,951,060 participants
- Where
- 7 sitesJapan
- Study dates
- Jul 2006to Mar 2011
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- 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
Who cannot join
- None
Trial locations and contacts
7 sites in 1 country.
7 sites in 1 country
Japan7 sites
Akita region group
Akita, Akita
Aomori region gruop
Aomori, Aomori
Chiba region group
Ichikawa, Chiba
Minami Kyusyu region group
Kagoshima and Miyazaki, Kagoshima and Miyazaki
Kita-Kyusyu region group
Kitakyushu, Fukuoka
Iwate region group
Morioka, Iwate
Sendai region group
Sendai, Miyagi
About this study
- 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.
Read the 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.
- Conditions
- Suicide
- Being tested
- Multimodal suicide prevention program, Suicide prevention program as usual
- Keywords
- Suicide, Prevention, Community
- Medical subject headings
- Suicide, Suicide Prevention
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Multimodal suicide prevention programBehavioural
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 usualBehavioural
Usual suicide prevention program
| Study group | Role | What they receive |
|---|---|---|
| Multimodal community intervention | Experimental | Multimodal suicide prevention program Receives: Behavioral: Multimodal suicide prevention program |
| Community intervention as usual | Active comparator | Suicide prevention program as usual Receives: Behavioral: Suicide prevention program as usual |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence of suicide attempts (completed suicides and suicide attempts except mild case )
Measured: 3.5years
Secondary outcomes (2)
Incidence of completed suicides
Measured: 3.5years
Incidence of suicide attempts
Measured: 3.5 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Aug 2008 (estimated)
- Study startJul 2006
- Primary completionDec 2009
- Study completionMar 2011
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for SuicideStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 1,951,060 participants (actual)
Sponsor and investigators
- Lead sponsor
- Japan Foundation for Neuroscience and Mental Health
- Sponsor type
- University, hospital or other
- Collaborators
- National Center of Neurology and Psychiatry, Japan
- Responsible party
- Sponsor
- Investigators
- Yutaka Ono, MD,PhD, Principal investigator, Keio University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00737165
- Sponsor's protocol ID
- J-MISP-02
- Other IDs
- UMIN000000460
- Acronym
- NOCOMIT-J
- Status last verified
- Oct 2013
- First submitted
- 15 Aug 2008
- Last updated
- 31 Oct 2013
- Results posted
- No
- Data monitoring committee
- Yes
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. doi: 10.1186/1471-2458-8-315.
PubMed 18793423Ono 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.
PubMed 18524043Ono 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.
PubMed 24130673
Study at a glance
From the registry record, last updated by the sponsor on 31 Oct 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Community Intervention Trial of Multimodal Suicide Prevention Program in Japan (NOCOMIT-J)
- ClinicalTrials.gov ID
- NCT00737165
- Acronym / sponsor ID
- NOCOMIT-J / J-MISP-02
- Conditions
- Suicide
- Keywords
- Suicide, Prevention, Community
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 1,951,060 participants (actual)
- Lead sponsor
- Japan Foundation for Neuroscience and Mental HealthUniversity, hospital or other
- Collaborators
- National Center of Neurology and Psychiatry, Japan
- Study start
- Jul 2006
- Primary completion
- Dec 2009 (actual)
- Study completion
- Mar 2011 (actual)
- First posted
- 18 Aug 2008 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
- 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.
Study design
- Primary purpose
- Prevention
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Multimodal community intervention | Experimental | Behavioral: Multimodal suicide prevention programMultimodal suicide prevention program |
| Community intervention as usual | Active comparator | Behavioral: Suicide prevention program as usualSuicide prevention program as usual |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (6 listed)
- Areas which meet the following criteria are eligible for this study;
Key exclusion criteria (1 listed)
- None
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Multimodal suicide prevention programA 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 | Behavioural | Multimodal community intervention |
| Suicide prevention program as usualUsual suicide prevention program | Behavioural | Community intervention as usual |
Primary outcome
Incidence of suicide attempts (completed suicides and suicide attempts except mild case )
Time frame: 3.5years
2 secondary outcomes
Incidence of completed suicides
Time frame: 3.5years
Incidence of suicide attempts
Time frame: 3.5 years
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 31 Oct 2013.
- Background: PubMed 18793423Ono 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.
- Background: PubMed 18524043Ono 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 publication: PubMed 24130673Ono 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Yutaka Ono, MD,PhD principal investigator
Keio University
7 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Multimodal suicide prevention program and Suicide prevention program as usual in people with Suicide, run by Japan Foundation for Neuroscience and Mental Health at 7 sites in Japan.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 31 Oct 2013. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 7 sites in Japan. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Incidence of suicide attempts (completed suicides and suicide attempts except mild case ) (time frame: 3.5years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00737165, which also lists 3 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 31 Oct 2013.