NCT02468466

Brief 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
89,700

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Jan 2005

Longer than P75 for not_applicable

Geographic Reach
1 country

11 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2005

Completed
7.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2012

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2012

Completed
2.5 years until next milestone

First Submitted

Initial submission to the registry

June 3, 2015

Completed
7 days until next milestone

First Posted

Study publicly available on registry

June 10, 2015

Completed
Last Updated

June 10, 2015

Status Verified

June 1, 2015

Enrollment Period

7.9 years

First QC Date

June 3, 2015

Last Update Submit

June 9, 2015

Conditions

Keywords

suicideprevention

Outcome Measures

Primary Outcomes (1)

  • 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

Secondary Outcomes (2)

  • Invitation rate in the screening component

    4 years post

  • Participation rate in the screening component

    4 years post

Study Arms (2)

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.

Behavioral: Multi-level suicide prevention programs

Community intervention as usual

ACTIVE COMPARATOR

Suicide prevention program as usual

Behavioral: Suicide prevention program as usual

Interventions

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.

Multi-level suicide prevention programs

Usual mental health program (not including depression screening among middle-aged)

Community intervention as usual

Eligibility Criteria

Age36 Years - 64 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • 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).

You may not qualify if:

  • A municipal area receiving further intervention including a depression screening for middle-aged adults.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (11)

Control group

Fujisaki, Aomori, Japan

Location

Intervention group

Gonohe, Aomori, Japan

Location

Intervention group

Hashikami, Aomori, Japan

Location

Intervention group

Hirakawa, Aomori, Japan

Location

Control group

Hiranai, Aomori, Japan

Location

Intervention group

Nanaku, Aomori, Japan

Location

Intervention group

Oirase, Aomori, Japan

Location

Control group

Ōwani, Aomori, Japan

Location

Control group

Rokunohe, Aomori, Japan

Location

Control group

Tohoku, Aomori, Japan

Location

Control group

Towada, Aomori, Japan

Location

Related Publications (2)

  • 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.

    PMID: 24647214BACKGROUND
  • 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.

    PMID: 23824236BACKGROUND

MeSH Terms

Conditions

Suicide

Condition Hierarchy (Ancestors)

Self-Injurious BehaviorBehavioral SymptomsBehavior

Study Officials

  • Hirofumi Oyama, MD, PhD

    Aomori University of Health and Welfare

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Faculty of Health Sciences

Study Record Dates

First Submitted

June 3, 2015

First Posted

June 10, 2015

Study Start

January 1, 2005

Primary Completion

December 1, 2012

Study Completion

December 1, 2012

Last Updated

June 10, 2015

Record last verified: 2015-06

Locations