- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02468466
A Community-based Depression Screening Intervention for Middle-aged Suicide
June 9, 2015 updated by: Hirofumi Oyama, Aomori University of Health and Welfare
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.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
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 Type
Interventional
Enrollment (Actual)
89700
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
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Aomori
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Fujisaki, Aomori, Japan
- Control group
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Gonohe, Aomori, Japan
- Intervention group
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Hashikami, Aomori, Japan
- Intervention group
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Hirakawa, Aomori, Japan
- Intervention group
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Hiranai, Aomori, Japan
- Control group
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Nanbu, Aomori, Japan
- Intervention group
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Oirase, Aomori, Japan
- Intervention group
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Owani, Aomori, Japan
- Control group
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Rokunohe, Aomori, Japan
- Control group
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Tohoku, Aomori, Japan
- Control group
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Towada, Aomori, Japan
- Control group
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
36 years to 64 years (Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
Inclusion Criteria:
- 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).
Exclusion Criteria:
- A municipal area receiving further intervention including a depression screening for middle-aged adults.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Prevention
- Allocation: Non-Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Active Comparator: Community intervention as usual
Suicide prevention program as usual
|
Usual mental health program (not including depression screening among middle-aged)
|
|
Experimental: Multi-level suicide prevention programs
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.
|
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.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
|---|---|
|
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
|
4 years pre versus 4 years post
|
Secondary Outcome Measures
Outcome Measure |
Time Frame |
|---|---|
|
Invitation rate in the screening component
Time Frame: 4 years post
|
4 years post
|
|
Participation rate in the screening component
Time Frame: 4 years post
|
4 years post
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Investigators
- Study Director: Hirofumi Oyama, MD, PhD, Aomori University of Health and Welfare
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
General 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.
- Oyama 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.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
January 1, 2005
Primary Completion (Actual)
December 1, 2012
Study Completion (Actual)
December 1, 2012
Study Registration Dates
First Submitted
June 3, 2015
First Submitted That Met QC Criteria
June 9, 2015
First Posted (Estimate)
June 10, 2015
Study Record Updates
Last Update Posted (Estimate)
June 10, 2015
Last Update Submitted That Met QC Criteria
June 9, 2015
Last Verified
June 1, 2015
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- KAKENHI #70404829
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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