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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT02468466
Other study ID # KAKENHI #70404829
Secondary ID
Status Completed
Phase N/A
First received June 3, 2015
Last updated June 9, 2015
Start date January 2005
Est. completion date December 2012

Study information

Verified date June 2015
Source Aomori University of Health and Welfare
Contact n/a
Is FDA regulated No
Health authority Japan: Ministry of Education, Culture, Sports, Science and Technology
Study type Interventional

Clinical 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 and individuals as the unit of analysis.


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.


Recruitment information / eligibility

Status Completed
Enrollment 89700
Est. completion date December 2012
Est. primary completion date December 2012
Accepts healthy volunteers No
Gender Both
Age group 36 Years to 64 Years
Eligibility 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 Design

Allocation: Non-Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Prevention


Related Conditions & MeSH terms


Intervention

Behavioral:
Multi-level suicide prevention programs
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 usual
Usual mental health program (not including depression screening among middle-aged)

Locations

Country Name City State
Japan Control group Fujisaki Aomori
Japan Intervention group Gonohe Aomori
Japan Intervention group Hashikami Aomori
Japan Intervention group Hirakawa Aomori
Japan Control group Hiranai Aomori
Japan Intervention group Nanbu Aomori
Japan Intervention group Oirase Aomori
Japan Control group Owani Aomori
Japan Control group Rokunohe Aomori
Japan Control group Tohoku Aomori
Japan Control group Towada Aomori

Sponsors (1)

Lead Sponsor Collaborator
Aomori University of Health and Welfare

Country where clinical trial is conducted

Japan, 

References & Publications (2)

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. — View Citation

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. — View Citation

Outcome

Type Measure Description Time frame Safety issue
Primary Change in suicide rates among adults aged 40-64 years between the 4-year pre- and implementation periods. 4 years pre versus 4 years post No
Secondary Invitation rate in the screening component 4 years post No
Secondary Participation rate in the screening component 4 years post No
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