UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	Cohort Study of Traffic Accident Experient about Psychiatric Health in Shiga, Japan
Title of the study (Brief title)	CTAP-Shiga
Region	Japan

Condition
Condition	Posttraumatic Stress Disorder Major Depressive Disorder
Classification by specialty	Psychiatry
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	It is commonly known that traffic accidents cause various mental disorders, such as PTSD. The results of the past studies about the onset ratio are full of changes. Effect of local differences, reinforcement degree of medical resources and/or degree of the stigma to the mental disorder, are expected. In this cohort study, we investigate the relations of mental disorder frequency of the traffic accident experients and application of medical resources, stigma to mental disorder, etc, in our area, Shiga Prefecture in Japan.
Basic objectives2	Others
Basic objectives -Others	Cause search by Cohort Study
Trial characteristics_1	Exploratory
Trial characteristics_2	Pragmatic
Developmental phase	Not applicable

Assessment
Primary outcomes	IES-R BDI-II SF-8
Key secondary outcomes	GHQ-12 DDS

Base
Study type	Observational

Study design
Basic design
Randomization
Randomization unit
Blinding
Control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms
Purpose of intervention
Type of intervention
Interventions/Control_1
Interventions/Control_2
Interventions/Control_3
Interventions/Control_4
Interventions/Control_5
Interventions/Control_6
Interventions/Control_7
Interventions/Control_8
Interventions/Control_9
Interventions/Control_10

Eligibility
Age-lower limit	20 years-old <=
Age-upper limit	Not applicable
Gender	Male and Female
Key inclusion criteria	The experients of traffic accidents that occurred during this survey in our area, Shiga Prefecture in Japan
Key exclusion criteria	Under 20 years old
Target sample size	400

Research contact person
Name of lead principal investigator	Takahiko Inagaki
Organization	Shiga University of Medical Science
Division name	Department of Community Psychiatric Medicine
Address	Seta Tsukinowa-cho, Otsu, Shiga, JAPAN
TEL	077-548-2291
Email	kerosuke@belle.shiga-med.ac.jp

Public contact
Name of contact person	Takao Nakabayashi
Organization	Shiga University of Medical Science
Division name	Department of Psychiatry
Address	Seta Tsukinowa-cho, Otsu, Shiga, JAPAN
TEL	077-548-2291
Homepage URL	http://com-psy.jp/activity/articles/47
Email	sumsptsd@gmail.com

Sponsor
Institute	Shiga University of Medical Science
Institute
Department

Funding Source
Organization	National Mutual Insurance Federation of Agricultural Cooperatives
Organization
Division
Category of Funding Organization	Non profit foundation
Nationality of Funding Organization	Japan

Other related organizations
Co-sponsor
Name of secondary funｄer(s)

Secondary IDs
Secondary IDs	NO
Study ID_1
Org. issuing International ID_1
Study ID_2
Org. issuing International ID_2
IND to MHLW

Institutions
Institutions	滋賀医科大学

Other administrative information
Date of disclosure of the study information	2015 Year 03 Month 19 Day

Progress
Recruitment status	Terminated
Date of protocol fixation	2015 Year 03 Month 01 Day
Anticipated trial start date	2015 Year 03 Month 19 Day
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Related information
URL releasing protocol
Publication of results	Unpublished
URL releasing results
Results
Other related information	Cohort Study

Management information
Registered date	2015 Year 03 Month 14 Day
Last modified on	2018 Year 01 Month 21 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000019500