SuicideNCT02468466
A Community-based Depression Screening Intervention for Middle-aged Suicide
A study testing Multi-level suicide prevention programs and Suicide prevention program as usual in people with Suicide, run by Aomori University of Health and Welfare at 11 sites in Japan.
Trial summary
The purpose of this study is to examine the effectiveness of a community-based depression-screening program for suicide prevention among middle-aged adults, the investigators conducted a quasi-experimental intervention study, using a parallel cluster design with communities at municipal level as the unit of allocation… Read more about this study
- Who is it for?
- Ages 36 to 64 years
- Conditions the study is for
- Suicide
- What is being tested?
- Multi-level suicide prevention programs 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
- 89,700 participants
- Where
- 11 sitesJapan
- Study dates
- Jan 2005to Dec 2012
- 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 36 to 64 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- A municipal area located in the following 4 Aomori Second Medical Zones: Hachinohe, Kamitosan, Aomori, and Tsugaru.
- A municipal area with the higher suicide rate than the prefectural average.
- A municipal area having the sufficient and coverable size to serve the intervention (population 10,000-99,999).
Who cannot join
- A municipal area receiving further intervention including a depression screening for middle-aged adults.
Trial locations and contacts
11 sites in 1 country.
11 sites in 1 country
Japan11 sites
Control group
Fujisaki, Aomori
Intervention group
Gonohe, Aomori
Intervention group
Hashikami, Aomori
Intervention group
Hirakawa, Aomori
Control group
Hiranai, Aomori
Intervention group
Nanaku, Aomori
Intervention group
Oirase, Aomori
Control group
Ōwani, Aomori
Control group
Rokunohe, Aomori
Control group
Tohoku, Aomori
Control group
Towada, Aomori
About this study
Official title: Impact of a Community-based Screening and Educational Intervention for Depression on Suicide Rates Among Japanese Middle-aged Adults
The purpose of this study is to examine the effectiveness of a community-based depression-screening program for suicide prevention among middle-aged adults, the investigators conducted a quasi-experimental intervention study, using a parallel cluster design with communities at municipal level as the unit of allocation and individuals as the unit of analysis.
Read the detailed description
Suicide is a major cause of premature death, particularly among middle-aged adults, in the majority of Western and Asian countries. A strong association of suicide and depression often indicates the necessity of a high-risk approach for suicide prevention. Improvements in identification and treatment can lead to better depression outcomes and suicide prevention. The investigators hypothesize that a 4-year community-based intervention, consisting of universal depression screening and subsequent care support in the target areas and health education programs, would result in reduced suicide rates among the middle-aged adult population in areas with a high suicide rate.
- Conditions
- Suicide
- Being tested
- Multi-level suicide prevention programs, Suicide prevention program as usual
- Keywords
- suicide, prevention
- Medical subject headings
- Suicide
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Multi-level suicide prevention programsBehavioural
The intervention included both screening and educational components. The screening component invited residents aged 36-64 years to participate in a two-step screening program. In the initial screening, a self-report questionnaire were mailed to all of those residents in the priority districts with a past high suicide rate. The second stage was conducted for the participants who screened positive though a semi-structural interview. Based on the results, participants who were diagnosed with a major depressive episode were provided with a referral to a psychiatry and support for treatment adherence. Written feedback on the screening results was mailed to all respondents. The educational component was implemented through workshops open to the general public (3 times every year) and local public newsletters (twice every year) designed to improve access and adherence to treatment and to reduce stigma associated with suicide and depression.
Suicide prevention program as usualBehavioural
Usual mental health program (not including depression screening among middle-aged)
| Study group | Role | What they receive |
|---|---|---|
| Multi-level suicide prevention programs | Experimental | The study team, including staff members from the intervention municipalities, provided each municipality with a standardized form of the work plan used in our study. The intervention municipality autonomously conducted the intervention program during the implementation period. Receives: Behavioral: Multi-level suicide prevention programs |
| 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.
Change in suicide rates among adults aged 40-64 years between the 4-year pre- and implementation periods.
Measured: 4 years pre versus 4 years post
Secondary outcomes (2)
Invitation rate in the screening component
Measured: 4 years post
Participation rate in the screening component
Measured: 4 years post
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Jun 2015 (estimated)
- Study startJan 2005
- Primary completionDec 2012
- Study completionDec 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)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
- 89,700 participants (actual)
Sponsor and investigators
- Lead sponsor
- Aomori University of Health and Welfare
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Hirofumi Oyama, Aomori University of Health and Welfare
- Investigators
- Hirofumi Oyama, MD, PhD, Study director, Aomori University of Health and Welfare
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02468466
- Sponsor's protocol ID
- KAKENHI #70404829
- Status last verified
- Jun 2015
- First submitted
- 3 Jun 2015
- Last updated
- 10 Jun 2015
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Oyama H, Sakashita T. Effects of universal screening for depression among middle-aged adults in a community with a high suicide rate. J Nerv Ment Dis. 2014 Apr;202(4):280-6. doi: 10.1097/NMD.0000000000000119.
PubMed 24647214Oyama H, Sakashita T. Differences in specific depressive symptoms among community-dwelling middle-aged Japanese adults before and after a universal screening intervention. Soc Psychiatry Psychiatr Epidemiol. 2014 Feb;49(2):251-8. doi: 10.1007/s00127-013-0735-6. Epub 2013 Jul 4.
PubMed 23824236
Study at a glance
From the registry record, last updated by the sponsor on 10 Jun 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Impact of a Community-based Screening and Educational Intervention for Depression on Suicide Rates Among Japanese Middle-aged Adults
- ClinicalTrials.gov ID
- NCT02468466
- Acronym / sponsor ID
- KAKENHI #70404829
- Conditions
- Suicide
- Keywords
- suicide, prevention
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 89,700 participants (actual)
- Lead sponsor
- Aomori University of Health and WelfareUniversity, hospital or other
- Study start
- Jan 2005
- Primary completion
- Dec 2012 (actual)
- Study completion
- Dec 2012 (actual)
- First posted
- 10 Jun 2015 (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 purpose of this study is to examine the effectiveness of a community-based depression-screening program for suicide prevention among middle-aged adults, the investigators conducted a quasi-experimental intervention study, using a parallel cluster design with communities at municipal level as the unit of allocation and individuals as the unit of analysis.
Detailed description
Suicide is a major cause of premature death, particularly among middle-aged adults, in the majority of Western and Asian countries. A strong association of suicide and depression often indicates the necessity of a high-risk approach for suicide prevention. Improvements in identification and treatment can lead to better depression outcomes and suicide prevention. The investigators hypothesize that a 4-year community-based intervention, consisting of universal depression screening and subsequent care support in the target areas and health education programs, would result in reduced suicide rates among the middle-aged adult population in areas with a high suicide rate.
Study design
- Primary purpose
- Prevention
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Multi-level suicide prevention programs | Experimental | Behavioral: Multi-level suicide prevention programsThe study team, including staff members from the intervention municipalities, provided each municipality with a standardized form of the work plan used in our study. The intervention municipality autonomously conducted the intervention program during the implementation period. |
| Community intervention as usual | Active comparator | Behavioral: Suicide prevention program as usualSuicide prevention program as usual |
Who may qualify
- Ages
- 36 to 64 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- A municipal area located in the following 4 Aomori Second Medical Zones: Hachinohe, Kamitosan, Aomori, and Tsugaru.
- A municipal area with the higher suicide rate than the prefectural average.
- A municipal area having the sufficient and coverable size to serve the intervention (population 10,000-99,999).
Key exclusion criteria (1 listed)
- A municipal area receiving further intervention including a depression screening for middle-aged adults.
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 |
|---|---|---|
| Multi-level suicide prevention programsThe intervention included both screening and educational components. The screening component invited residents aged 36-64 years to participate in a two-step screening program. In the initial screening, a self-report questionnaire were mailed to all of those residents in the priority districts with a past high suicide rate. The second stage was conducted for the participants who screened positive though a semi-structural interview. Based on the results, participants who were diagnosed with a major depressive episode were provided with a referral to a psychiatry and support for treatment adherence. Written feedback on the screening results was mailed to all respondents. The educational component was implemented through workshops open to the general public (3 times every year) and local public newsletters (twice every year) designed to improve access and adherence to treatment and to reduce stigma associated with suicide and depression. | Behavioural | Multi-level suicide prevention programs |
| Suicide prevention program as usualUsual mental health program (not including depression screening among middle-aged) | Behavioural | Community intervention as usual |
Primary outcome
Change in suicide rates among adults aged 40-64 years between the 4-year pre- and implementation periods.
Time frame: 4 years pre versus 4 years post
2 secondary outcomes
Invitation rate in the screening component
Time frame: 4 years post
Participation rate in the screening component
Time frame: 4 years post
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 10 Jun 2015.
- Background: PubMed 24647214Oyama H, Sakashita T. Effects of universal screening for depression among middle-aged adults in a community with a high suicide rate. J Nerv Ment Dis. 2014 Apr;202(4):280-6. doi: 10.1097/NMD.0000000000000119.
- Background: PubMed 23824236Oyama H, Sakashita T. Differences in specific depressive symptoms among community-dwelling middle-aged Japanese adults before and after a universal screening intervention. Soc Psychiatry Psychiatr Epidemiol. 2014 Feb;49(2):251-8. doi: 10.1007/s00127-013-0735-6. Epub 2013 Jul 4.
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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.
Hirofumi Oyama, MD, PhD study director
Aomori University of Health and Welfare
11 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Multi-level suicide prevention programs and Suicide prevention program as usual in people with Suicide, run by Aomori University of Health and Welfare at 11 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 3 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 10 Jun 2015. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 11 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?
Change in suicide rates among adults aged 40-64 years between the 4-year pre- and implementation periods. (time frame: 4 years pre versus 4 years post). 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 NCT02468466, which also lists 2 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 10 Jun 2015.