UMIN-CTR Clinical Trial

Public title

A comprehensive analysis of psychiatric symptoms after traffic accidents; a multicenter, prospective registry trial.

Acronym

A comprehensive analysis of psychiatric symptoms after traffic accidents; a multicenter, prospective registry trial.

Scientific Title

A comprehensive analysis of psychiatric symptoms after traffic accidents; a multicenter, prospective registry trial.

Scientific Title:Acronym

A comprehensive analysis of psychiatric symptoms after traffic accidents; a multicenter, prospective registry trial.

Region

Japan

Condition

Injured patients due to traffic accidents

Classification by specialty

Emergency medicine

Intensive care medicine

Classification by malignancy

Others

Genomic information

YES

Narrative objectives1

To clarify factors associated with psychiatric symptoms after traffic accident such as pottraumatic stress disorder or depression.

Basic objectives2

Others

Basic objectives -Others

to explore risk factors of outcomes

Trial characteristics_1

Trial characteristics_2

Developmental phase

Primary outcomes

Psychiatric disorders such as PTSD or depression at one year after traffic accident

Key secondary outcomes

Study type

Observational

Basic design

Randomization

Randomization unit

Blinding

Control

Stratification

Dynamic allocation

Institution consideration

Blocking

Concealment

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

Age-lower limit

20

years-old

<=

Age-upper limit

79

years-old

>=

Gender

Male and Female

Key inclusion criteria

1. patients transferred to hospital due to traffic accidents.
2. patients admitted to hospital.
3. Adults between 20 and 79 years old.
4. able to communicate in Japanese.

Key exclusion criteria

1.Those who are unable to be interviewed (including those with cognitive decline, MMSE < 24,or effects of trauma such as higher brain dysfunction due to severe head injuries).
2.Those who dose not give their consent to participate in the research.
3.Those who were injured by suicide attempt.
4.Those who were judged as inappropriate by the physician/psychologist in charge (e.g., when there is a situation in which conducting an interview may lead to deterioration of the patient's condition)

Target sample size

300

Name of lead principal investigator

1st name	Takero
Middle name
Last name	Terayama

Organization

National Defense Medical College

Division name

Psychiatry department

Zip code

3590042

Address

Namiki3-2, Tokorozawa, Saitama, Japan

TEL

+81-4-2995-1211

Email

takero.for.medical.journal@gmail.com

Name of contact person

1st name	Takero
Middle name
Last name	Terayama

Organization

National Defense Medical College

Division name

Psychiatry Department

Zip code

359-0042

Address

Namiki 3-2, Tokorozawa, Saitama, Japan

TEL

+81-4-2995-1211

Homepage URL

Email

takero.for.medical.journal@gmail.com

Institute

National Defense Medical College

Institute

Department

Personal name

Organization

Ministry of Education, Culture, Sports, Science and Technology

Organization

Division

Category of Funding Organization

Japanese Governmental office

Nationality of Funding Organization

Co-sponsor

Name of secondary funder(s)

Organization

National Defense Medical College

Address

Namiki3-2, Tokorozawa, Saitama, Japan

Tel

+81-4-2995-1211

Email

ins010@ndmc.ac.jp

Secondary IDs

NO

Study ID_1

Org. issuing International ID_1

Study ID_2

Org. issuing International ID_2

IND to MHLW

Institutions

Date of disclosure of the study information

2021

Year

01

Month

10

Day

URL releasing protocol

Publication of results

Unpublished

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

Recruitment status

Open public recruiting

Date of protocol fixation

2021

Year

01

Month

01

Day

Date of IRB

2020

Year

07

Month

14

Day

Anticipated trial start date

2021

Year

01

Month

15

Day

Last follow-up date

2023

Year

12

Month

31

Day

Date of closure to data entry

Date trial data considered complete

Date analysis concluded

Other related information

Research Procedure
1.Date of patient emergency transport
Distribute research pamphlet to the patient or patient's family.
2.Within 1 week after admission
Patients who may meet the eligibility criteria will be given an explanation of the study using a video prepared for the study. Patients with an MMSE score of less than 24 will be excluded at this time. For other self-administered questionnaires, including psychological evaluation scales, responses will be obtained on paper or by using a research tablet (iPad).
3. During hospitalization
For patients who meet the eligibility criteria for fMRI, fMRI will be performed within 14 days from the date of injury.
4. 2,6, and 12 months after injury
Self-administered questionnaires including CAPS-5 and other psychological rating scales will be administered. If the patient is hospitalized, have them complete the questionnaire using the same instrument as within 2 days of admission. The CAPS-5 will be administered at home in the form of a web-based interview using a cell phone, tablet, or PC. The CAPS-5 will be conducted at home in the form of a web-based interview using a mobile phone, tablet, or PC. The psychologist in charge will coordinate the schedule in advance, allowing two weeks before and after the interview.

Registered date

2021

Year

01

Month

01

Day

Last modified on

2021

Year

07

Month

03

Day

Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000048944