UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	Kitaibaraki Genki Zukuri project
Title of the study (Brief title)	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

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	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

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	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	Takashi Asada
Organization	University of Tsukuba
Division name	Department of Psychiatry
Address	1-1-1 Tennodai, Tsukuba, Ibaraki
TEL	029-853-3182
Email	tasada@md.tsukuba.ac.jp

Public contact
Name of contact person	Shinji Sato
Organization	University of Tsukuba
Division name	Department of Psychiatry
Address	1-1-1 Tnnodai, Tsukuba, Ibaraki
TEL	029-853-3182
Homepage URL
Email	sato-shinji@spu.ac.jp

Sponsor
Institute	Universityu of Tsukuba
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	Japanese Governmental office
Nationality of Funding Organization

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

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

Progress
Recruitment status	Completed
Date of protocol fixation	2012 Year 03 Month 31 Day
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

Related information
URL releasing protocol
Publication of results	Unpublished
URL releasing results
Results
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
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000020288