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

Email

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


Email

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


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

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


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name