UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000016801 |
|---|---|
| Receipt number | R000019500 |
| Scientific Title | Cohort Study of Traffic Accident Experient about Psychiatric Health in Shiga, Japan |
| Date of disclosure of the study information | 2015/03/19 |
| Last modified on | 2018/01/21 14:34:36 |
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Basic information
Public title
Cohort Study of Traffic Accident Experient about Psychiatric Health in Shiga, Japan
Acronym
CTAP-Shiga
Scientific Title
Cohort Study of Traffic Accident Experient about Psychiatric Health in Shiga, Japan
Scientific Title:Acronym
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
| 1st name | |
| Middle name | |
| Last name | Takahiko Inagaki |
Organization
Shiga University of Medical Science
Division name
Department of Community Psychiatric Medicine
Zip code
Address
Seta Tsukinowa-cho, Otsu, Shiga, JAPAN
TEL
077-548-2291
kerosuke@belle.shiga-med.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Takao Nakabayashi |
Organization
Shiga University of Medical Science
Division name
Department of Psychiatry
Zip code
Address
Seta Tsukinowa-cho, Otsu, Shiga, JAPAN
TEL
077-548-2291
Homepage URL
http://com-psy.jp/activity/articles/47
sumsptsd@gmail.com
Sponsor or person
Institute
Shiga University of Medical Science
Institute
Department
Personal name
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)
IRB Contact (For public release)
Organization
Address
Tel
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 |
Related information
URL releasing protocol
Publication of results
Unpublished
Result
URL related to results and publications
Number of participants that the trial has enrolled
Results
Results date posted
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
Participant flow
Adverse events
Outcome measures
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
Terminated
Date of protocol fixation
| 2015 | Year | 03 | Month | 01 | Day |
Date of IRB
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
Other
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000019500
