Ignite Creation Date:
2025-12-24 @ 4:25 PM
Ignite Modification Date:
2026-01-24 @ 10:40 PM
Study NCT ID:
NCT02468466
Status:
COMPLETED
Last Update Posted:
2015-06-10
First Post:
2015-06-03
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
A Community-based Depression Screening Intervention for Middle-aged Suicide
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D013405', 'term': 'Suicide'}], 'ancestors': [{'id': 'D016728', 'term': 'Self-Injurious Behavior'}, {'id': 'D001526', 'term': 'Behavioral Symptoms'}, {'id': 'D001519', 'term': 'Behavior'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NON_RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'PREVENTION', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 89700}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2005-01'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2015-06', 'completionDateStruct': {'date': '2012-12', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2015-06-09', 'studyFirstSubmitDate': '2015-06-03', 'studyFirstSubmitQcDate': '2015-06-09', 'lastUpdatePostDateStruct': {'date': '2015-06-10', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2015-06-10', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2012-12', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Change in suicide rates among adults aged 40-64 years between the 4-year pre- and implementation periods.', 'timeFrame': '4 years pre versus 4 years post'}], 'secondaryOutcomes': [{'measure': 'Invitation rate in the screening component', 'timeFrame': '4 years post'}, {'measure': 'Participation rate in the screening component', 'timeFrame': '4 years post'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['suicide', 'prevention'], 'conditions': ['Suicide']}, 'referencesModule': {'references': [{'pmid': '24647214', 'type': 'BACKGROUND', '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.'}, {'pmid': '23824236', 'type': 'BACKGROUND', 'citation': '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.'}]}, 'descriptionModule': {'briefSummary': '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.', 'detailedDescription': '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.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT'], 'maximumAge': '64 Years', 'minimumAge': '36 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* A municipal area located in the following 4 Aomori Second Medical Zones: Hachinohe, Kamitosan, Aomori, and Tsugaru.\n* A municipal area with the higher suicide rate than the prefectural average.\n* A municipal area having the sufficient and coverable size to serve the intervention (population 10,000-99,999).\n\nExclusion Criteria:\n\n* A municipal area receiving further intervention including a depression screening for middle-aged adults.'}, 'identificationModule': {'nctId': 'NCT02468466', 'briefTitle': 'A Community-based Depression Screening Intervention for Middle-aged Suicide', 'organization': {'class': 'OTHER', 'fullName': 'Aomori University of Health and Welfare'}, 'officialTitle': 'Impact of a Community-based Screening and Educational Intervention for Depression on Suicide Rates Among Japanese Middle-aged Adults', 'orgStudyIdInfo': {'id': 'KAKENHI #70404829'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Multi-level suicide prevention programs', 'description': '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.', 'interventionNames': ['Behavioral: Multi-level suicide prevention programs']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Community intervention as usual', 'description': 'Suicide prevention program as usual', 'interventionNames': ['Behavioral: Suicide prevention program as usual']}], 'interventions': [{'name': 'Multi-level suicide prevention programs', 'type': 'BEHAVIORAL', 'description': '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.', 'armGroupLabels': ['Multi-level suicide prevention programs']}, {'name': 'Suicide prevention program as usual', 'type': 'BEHAVIORAL', 'description': 'Usual mental health program (not including depression screening among middle-aged)', 'armGroupLabels': ['Community intervention as usual']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Fujisaki', 'state': 'Aomori', 'country': 'Japan', 'facility': 'Control group', 'geoPoint': {'lat': 40.65314, 'lon': 140.49961}}, {'city': 'Gonohe', 'state': 'Aomori', 'country': 'Japan', 'facility': 'Intervention group'}, {'city': 'Hashikami', 'state': 'Aomori', 'country': 'Japan', 'facility': 'Intervention group'}, {'city': 'Hirakawa', 'state': 'Aomori', 'country': 'Japan', 'facility': 'Intervention group', 'geoPoint': {'lat': 40.58728, 'lon': 140.57107}}, {'city': 'Hiranai', 'state': 'Aomori', 'country': 'Japan', 'facility': 'Control group', 'geoPoint': {'lat': 40.92028, 'lon': 140.95556}}, {'city': 'Nanaku', 'state': 'Aomori', 'country': 'Japan', 'facility': 'Intervention group', 'geoPoint': {'lat': 40.40089, 'lon': 141.27271}}, {'city': 'Oirase', 'state': 'Aomori', 'country': 'Japan', 'facility': 'Intervention group', 'geoPoint': {'lat': 40.6859, 'lon': 139.97919}}, {'city': 'Ōwani', 'state': 'Aomori', 'country': 'Japan', 'facility': 'Control group', 'geoPoint': {'lat': 40.5197, 'lon': 140.56872}}, {'city': 'Rokunohe', 'state': 'Aomori', 'country': 'Japan', 'facility': 'Control group'}, {'city': 'Tohoku', 'state': 'Aomori', 'country': 'Japan', 'facility': 'Control group'}, {'city': 'Towada', 'state': 'Aomori', 'country': 'Japan', 'facility': 'Control group', 'geoPoint': {'lat': 40.62049, 'lon': 141.21067}}], 'overallOfficials': [{'name': 'Hirofumi Oyama, MD, PhD', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Aomori University of Health and Welfare'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Aomori University of Health and Welfare', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Faculty of Health Sciences', 'investigatorFullName': 'Hirofumi Oyama', 'investigatorAffiliation': 'Aomori University of Health and Welfare'}}}}