UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000017501 |
|---|---|
| Receipt number | R000020288 |
| Scientific Title | Kitaibaraki Genki Zukuri project |
| Date of disclosure of the study information | 2015/05/11 |
| Last modified on | 2016/05/11 09:27:24 |
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Basic information
Public title
Kitaibaraki Genki Zukuri project
Acronym
Kitaibaraki project
Scientific Title
Kitaibaraki Genki Zukuri project
Scientific Title:Acronym
Kitaibaraki project
Region
| Japan |
Condition
Condition
volunteers
Classification by specialty
| Psychiatry |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
Investigation of epidemiology and intervention to depression and PTSD in Kitaibaraki city after 3.11 East Great Earthquake.
Basic objectives2
Others
Basic objectives -Others
Investigation of epidemiology and intervention to depression and PTSD in Kitaibaraki city after 3.11 East Great Earthquake.
Trial characteristics_1
Exploratory
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
CSE-D, IES-R, MINI
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
Factorial
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
No treatment
Stratification
NO
Dynamic allocation
NO
Institution consideration
Institution is not considered as adjustment factor.
Blocking
NO
Concealment
No need to know
Intervention
No. of arms
2
Purpose of intervention
Prevention
Type of intervention
| Behavior,custom |
Interventions/Control_1
exercise
Interventions/Control_2
Personal computer classroom
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
adults in Kitibaraki city
Key exclusion criteria
Person who lack the judgment ability
Target sample size
1500
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Takashi Asada |
Organization
University of Tsukuba
Division name
Department of Psychiatry
Zip code
Address
1-1-1 Tennodai, Tsukuba, Ibaraki
TEL
029-853-3182
tasada@md.tsukuba.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Shinji Sato |
Organization
University of Tsukuba
Division name
Department of Psychiatry
Zip code
Address
1-1-1 Tnnodai, Tsukuba, Ibaraki
TEL
029-853-3182
Homepage URL
sato-shinji@spu.ac.jp
Sponsor or person
Institute
Universityu of Tsukuba
Institute
Department
Personal name
Funding Source
Organization
MHLW(Japan)
Organization
Division
Category of Funding Organization
Japanese Governmental office
Nationality of Funding Organization
Other related organizations
Co-sponsor
NCNP
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
北茨城市立病院
Other administrative information
Date of disclosure of the study information
| 2015 | Year | 05 | Month | 11 | 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
Completed
Date of protocol fixation
| 2012 | Year | 03 | Month | 31 | Day |
Date of IRB
Anticipated trial start date
| 2012 | Year | 12 | Month | 01 | Day |
Last follow-up date
| 2014 | Year | 02 | Month | 14 | Day |
Date of closure to data entry
| 2014 | Year | 12 | Month | 01 | Day |
Date trial data considered complete
| 2014 | Year | 12 | Month | 01 | Day |
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2015 | Year | 05 | Month | 11 | Day |
Last modified on
| 2016 | Year | 05 | Month | 11 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000020288
