UMIN-CTR Clinical Trial

Basic information
Public title	The study of evaluation the gatekeeper training program for improving radiation health anxiety
Acronym	The study of evaluation the gatekeeper training program for improving radiation health anxiety
Scientific Title	The study of evaluation the gatekeeper training program for improving radiation health anxiety
Scientific Title:Acronym	The study of evaluation the gatekeeper training program for improving radiation health anxiety
Region	Japan

Condition
Condition	radiation health anxiety and mental disorders
Classification by specialty	Psychiatry
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	Measuring the effectiveness of interventions using training programs that include skills necessary for dealing with radiation health anxiety and general mental disorders
Basic objectives2	Others
Basic objectives -Others	For counselors who provide consultation to evacuees due to the nuclear disaster
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	(1) The understanding and maintaining level of the basic knowledge on how to deal with radiation health anxiety and mental health problems (2) The confidence level of dealing with radiation health anxiety and mental health problems
Key secondary outcomes

Base
Study type	Interventional

Study design
Basic design	Single arm
Randomization	Non-randomized
Randomization unit
Blinding	Open -no one is blinded
Control	Uncontrolled
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms	1
Purpose of intervention	Educational,Counseling,Training
Type of intervention	Other
Interventions/Control_1	Intervention using the developed training program
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

Eligibility
Age-lower limit	Not applicable
Age-upper limit	Not applicable
Gender	Male and Female
Key inclusion criteria	All counselors who have worked in the social welfare council in Minami-Soma city and Iitate Village
Key exclusion criteria	Disagreement with intervention
Target sample size	30

Research contact person
Name of lead principal investigator	1st name Seiji Middle name Last name YASUMURA
Organization	Fukushima Medical University
Division name	Department of Public Health School of Medicine
Zip code	960-1295
Address	1-Hikarigaoka, Fukushima City
TEL	024-547-1180
Email	public-h@fmu.ac.jp

Public contact
Name of contact person	1st name Masatsugu Middle name Last name ORUI
Organization	Fukushima Medical University
Division name	Department of Public Health School of Medicine
Zip code	960-1295
Address	1-Hikarigaoka, Fukushima City
TEL	024-547-1180
Homepage URL
Email	oruima@fmu.ac.jp

Sponsor
Institute	Department of Mental Health, Graduate School of Medicine, The University of Tokyo.
Institute
Department

Funding Source
Organization	The Ministry of Environment, Japan
Organization
Division
Category of Funding Organization	Japanese Governmental office
Nationality of Funding Organization

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

IRB Contact (For public release)
Organization	Fukushima Medical University, Department of Public Health School of Medicine
Address	1-Hikarigaoka, Fukushima city
Tel	024-547-1180
Email	oruima@fmu.ac.jp

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	2019 Year 11 Month 01 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	2019 Year 11 Month 01 Day
Date of IRB	2016 Year 07 Month 16 Day
Anticipated trial start date	2019 Year 11 Month 01 Day
Last follow-up date	2020 Year 02 Month 27 Day
Date of closure to data entry	2020 Year 02 Month 29 Day
Date trial data considered complete	2020 Year 03 Month 10 Day
Date analysis concluded	2020 Year 04 Month 10 Day

Other
Other related information

Management information
Registered date	2019 Year 11 Month 01 Day
Last modified on	2020 Year 05 Month 02 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000043831