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A survey on the prevalence and validity of screening test for acute stress disorder and posttraumatic stress disorder in traffic injuries

Status Approved

  • First Submitted Date

    2018/11/05

  • Registered Date

    2019/03/25

  • Last Updated Date

    2021/07/15

CRIS Required

WHO ICTRP (International Clinical Trial Registry Platform) Required

  • 1. Background

    Background - CRIS Registration Number, Unique Protocol ID, Public/Brief Title, Scientific Title, Acronym, MFDS Regulated Study, IND/IDE Protocol, Registered at Other Registry, Name of Registry/Registration Number
    CRIS
    Registration Number
    KCT0003660
    Unique Protocol ID WMCSB 201802-10
    Public/Brief Title A survey on the posttraumatic stress disorder and aute stress disorder in traffic injuries
    Scientific Title A survey on the prevalence and validity of screening test for acute stress disorder and posttraumatic stress disorder in traffic injuries
    Acronym TA_PTSD_ASD
    MFDS Regulated Study No
    IND/IDE Protocol No
    Registered at Other Registry No
    Healthcare Benefit Approval Status Not applicable
  • 2. Institutional Review Board / Ethics Committee

    Institutional Review Board Information
    Board Approval Status Submitted approval
    Board Approval Number WMCSB 201809-72-180647
    Approval Date 2018-09-11
    Institutional Review Board Name Institutional Review Board of Wonkwang University Sanbon Hospital
    Institutional Review Board Address Wonkwang University Sanbon Hospital, 321 Sanbon-ro Gunpo city Gyeonggi-Do
    Institutional Review Board Telephone 031-390-2586
    Data Monitoring Committee No
  • 3. Contact Details

    Contact Details Information - Contact Person for Principal Investigator / Scientific Queries, Contact Person for Public Queries, Contact Person for Updating Information의 Name, Title, Email, Telephone, Cellular Phone, Affiliation, Address
    Contact Person for Principal Investigator / Scientific Queries
    Name Hyung Won Kang
    Title professor
    Telephone +82-31-390-2762
    Affiliation Wonkwang University Sanbon Hospital
    Address 321, Sanbon-ro Gunpo City, Gyeonggi-do
    Contact Person for Public Queries
    Name Hyung Won Kang
    Title Professor
    Telephone +82-31-390-2762
    Affiliation Wonkwang University Sanbon Hospital
    Address 321, Sanbon-ro Gunpo City, Gyeonggi-do
    Contact Person for Updating Information
    Name Moon Joo Cheong
    Title Ph.D
    Telephone +82-31-390-2763
    Affiliation Hanyang University
    Address 222, Wangsimni-ro, Seongdong-gu, Seoul, 04763, Korea
  • 4. Status

    Status Information - Study Site, Overall Recruitment Status, Date of First Enrollment, Status of First Enrollment, Target Number of Participant, Primary Completion Date, Recruitment Status by Participating Study Site, Name of Study Site, Recruitment Status, Date of First Enrollment, Status of First Enrollemnt
    Study Site Multi-center Number of center : 2
    Overall Recruitment Status Completed
    Date of First Enrollment 2018-12-11 Actual
    Target Number of Participant 300
    Primary Completion Date 2019-12-11 , Actual
    Study Completion Date 2020-07-29 , Actual
    Recruitment Status by Participating Study Site 1
    Name of Study Wonkwang University Sanbon Hospital
    Recruitment Status Completed
    Date of First Enrollment 2018-12-11 ,
    Recruitment Status by Participating Study Site 2
    Name of Study Pusan National University Korean Medicine Hospital
    Recruitment Status Completed
    Date of First Enrollment 2019-12-11 ,
  • 5. Source of Monetary / Material Support

    Source of Monetary / Material Support Information - Organization Name, Organization Type, Project ID
    1. Source of Monetary/Material Support
    Organization Name Pusan National University Korean Medicine Hospital
    Organization Type Medical Institute
    Project ID HB16C0013
  • 6. Sponsor Organization

    Sponsor Organization Information - Organization Name, Organization Type
    1. Sponsor Organization
    Organization Name Wonkwang University Sanbon Hospital
    Organization Type Medical Institute
  • 7. Study Summary

    Study Summary Information
    Lay Summary
    Although there is a high incidence of acute stress disorder(ASD) and post traumatic stress disorder(PTSD) caused by traffic accidents, patients who suffer from ASD and PTSD after traffic accidents don't usually get psychological intervention in the beginning of the accident. The purpose of this study is to make the rationale for Korean medicine clinical practice guidelines recommendation for ASD and PTSD in primary care and to verify the usefulness of existing testing tools to screen the ASD and PTSD.
  • 8. Study Design

    Study Design Information - Study Type, Observational Study Model, Time Perspective, Target Number of Participant, Cohort/Group Number, Cohort/Group, Cohort/Group Label, Cohort/Group Description, Biospecimen Collection & Archiving, Biospecimen Description
    Study Type Observational Study
    Observational Study Model Case-only
    Time Perspective Cross-sectional  
    Target Number of Participant 300
    Cohort/Group Number 1
    Cohort/
    Group 1

    Cohort/Group Label

    The Group of patient who experienced a traffic accident

    Cohort/Group Description

    A person who has experienced a traffic accident and who is between the ages of 20 and 70 years old and who has voluntarily agreed to the written consent of the patient or the legal representative in the clinical trial agreement will be researched about the Acute Stress Disorder and Post Traumatic Stress Diorder. 
    This study will confirm the prevalence of Acute Stress Disorder and Post Traumatic Stress Disorder in traffic accident victims.
    Biospecimen
    Collection & Archiving
    Not collect nor Archive
    Biospecimen Description
  • 9. Subject Eligibility

    Subject Eligibility Information
    Study Population Description
    Among the residents of Seoul, Gyeonggi (Gunpo, Incheon), Gwangju, and Yangsan, who have experienced traffic accidents, those who going to university hospitals and Oriental hospitals are between 20 and 70 years of age and have voluntarily agreed to the written consent of the patient or legal representative to be. There is no restriction on gender.
    Sampling Method
    Quota sample variant form of the subjective judgment sampling method among the non-probabilistic sampling methods, will be used to carry out involving the subjective judgment of the experts in order to obtain a representative sampling.
    Condition(s)/Problem(s) * (F00-F99)Mental and behavioural disorders 
       (F43.1)Post-traumatic stress disorder 

    Posttraumatic Stress Disorders Acute Stress Disorders
    Rare Disease No
    Inclusion Criteria

    Gender

    Both

    Age

    20Year~70Year

    Description

    1) Age: 20 to 70 years male, female adult
    2) The patient who experienced a traffic accident
    3) The patient who has been more than 3 days and less than 1 year since a traffic accident
    4) The patient who voluntarily agrees in writing to the clinical trial agreement
    Exclusion Criteria
    1) The patient with a history of major psychiatric disorders such as schizophrenia, delusional disorder, bipolar disorder, alcohol or substance abuse disorder diagnosed by The Diagnostic and Statistical Manual of Mental Disorders, Fifth Edition(DSM-IV)before a traffic accident.
    2) The patient who had cervical spine or lumbar surgery before a traffic accident
    3) The patient with chronic disease that may affect the outcome of the clinical study
    4) The patient with congenital spinal disease
    5) The patient who participated in other clinical studies within a month
    6) The patient who can not communicate normally due to dementia or mild cognitive impairment.
    7) Pregnant woman
    Healthy Volunteers No
  • 10. Outcome Measure(s)

    Outcome Measure(s) Information - Type of Primary Outcome, Primary Outcome, Outcome, Timepoint, Secondary Outcome, Outcome, Timepoint
    Type of Primary Outcome Not applicable
    Primary Outcome(s) 1
    Outcome
    Basic information
    Timepoint
    At the time of survey
    Secondary Outcome(s) 1
    Outcome
    PC-PTSD-5(The Primary Care PTSD Screen for DSM-5)
    Timepoint
    At the time of survey
    Secondary Outcome(s) 2
    Outcome
    PCL-5-K(Korean version of PTSD Checklist-5)
    Timepoint
    At the time of survey
    Secondary Outcome(s) 3
    Outcome
    HADS(Hospital anxiety and depression scale)
    Timepoint
    At the time of survey
    Secondary Outcome(s) 4
    Outcome
    CSEI-S(The Core Seven-Emotions Inventory Short Form)
    Timepoint
    At the time of survey
    Secondary Outcome(s) 5
    Outcome
    NRS((Numeric Rating Scale)
    Timepoint
    At the time of survey
    Secondary Outcome(s) 6
    Outcome
    The instrument of pattern identification for jing ji and zheng chong
    Timepoint
    At the time of survey
  • 11. Study Results and Publication

    Study Results and Publication Information - Result Registered, Final Enrollment Number, Number of Publication, Publications, Results Upload, Date of Posting Results, Protocol URL or File Upload, Brief Summary
    Result Registered No
  • 12. Sharing of Study Data(Deidentified Individual-Patient Data, IPD)

    Sharing of Study Data Information - Sharing Statement, Time of Sharing, Way of Sharing
    Sharing Statement Yes
    Time of Sharing 2020. 12
    Way of Sharing Available on Request
    (onp21@hanmail.net)
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