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Recruitment status Completed
Unique ID issued by UMIN UMIN000008562
Receipt No. R000010066
Scientific Title Neural underpinnings of a vulunerability factor, an acquired sign, and a resilience process of post-earthquake stress.
Date of disclosure of the study information 2012/07/30
Last modified on 2016/08/02

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Basic information
Public title Neural underpinnings of a vulunerability factor, an acquired sign, and a resilience process of post-earthquake stress.
Acronym A severe disaster impacts on human cognition and behaviors.
Scientific Title Neural underpinnings of a vulunerability factor, an acquired sign, and a resilience process of post-earthquake stress.
Scientific Title:Acronym A severe disaster impacts on human cognition and behaviors.
Region
Japan

Condition
Condition Posttraumatic stress disorder
Classification by specialty
Psychosomatic Internal Medicine Psychiatry
Classification by malignancy Others
Genomic information YES

Objectives
Narrative objectives1 To reveal the neural underpinnings of a vulnerability factor, acquired sign and a resilience process f post-earthquake stress.
Basic objectives2 Others
Basic objectives -Others Psychiatric symptoms
Trial characteristics_1 Confirmatory
Trial characteristics_2 Pragmatic
Developmental phase

Assessment
Primary outcomes Gray matter volume
Key secondary outcomes

In outcomes field, the entry of just a few words such as "safety" or "efficiency" will not be accepted. Specify the name of outcome measures, including the time when you plan to measure. Usually, only one primary outcome is accepted. Write the other outcomes in "secondary outcomes" field.

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

In interventions field, include the details of interventions, such as duration, amount, and frequency. If the intervention includes prescription or use of medical devices, duration is required.

Eligibility
Age-lower limit
18 years-old <=
Age-upper limit
65 years-old >
Gender Male and Female
Key inclusion criteria Right-handed healthy subjects
Key exclusion criteria History of psychiatric diseases, traumatic brain injury
Target sample size 100

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Ryuta Kawashima
Organization IDAC, Tohoku University
Division name Functional Brain Imaging
Zip code
Address 4-1 Seiryou-machi, Aoba-ku, Sendai
TEL 022-717-7988
Email

Public contact
Name of contact person
1st name
Middle name
Last name Atsushi Sekiguchi
Organization IDAC, Tohoku university
Division name Advanced Brain Science
Zip code
Address
TEL 022-717-7988
Homepage URL
Email asekiguchi@idac.tohoku.ac.jp

Sponsor
Institute IDAC, Tohoku University
Institute
Department

Sponsor means an organization that is responsible for plan, deployment and
report of the research including funding management. It doesn't mean
funding agency". Therefore, all clinical trial should have the one.

Funding Source
Organization MHLW, Japan
Organization
Division
Category of Funding Organization
Nationality of Funding Organization

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

IRB Contact (For public release)
Organization
Address
Tel
Email

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

Other administrative information
Date of disclosure of the study information
2012 Year 07 Month 30 Day

Related information
URL releasing protocol
Publication of results Published

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 Completed
Date of protocol fixation
2011 Year 06 Month 01 Day
Date of IRB
Anticipated trial start date
2012 Year 07 Month 30 Day
Last follow-up date
2013 Year 06 Month 01 Day
Date of closure to data entry
2016 Year 08 Month 02 Day
Date trial data considered complete
Date analysis concluded

Other
Other related information Retrospective design for data of pre-earthquake and soon after the earthquake. Prospective design for follow up data and those of control group.

Management information
Registered date
2012 Year 07 Month 30 Day
Last modified on
2016 Year 08 Month 02 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000010066


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