UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	Effects of a group alcohol intervention for evacuees after the Great East Japan Earthquake
Title of the study (Brief title)	Alcohol Intervention
Region	Japan

Condition
Condition	The evacuees who might have risk of alcohol abuse
Classification by specialty	Adult
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	This study is to identify the risk factor of alcohol use disorders among evacuees after the Great East Japan Earthquake, and develop a group alcohol intervention program.
Basic objectives2	Others
Basic objectives -Others	This presents two studies. The first study aims to develop a questionnaire to identify change in alcohol consumption factors among the evacuees after the Great East Japan Earthquake. In the second study, we developed a group alcohol intervention program based on the Hizen Alcoholism Program by Yuzuriha (HAPPY) to investigate how the intervention could be effective for the evacuees who might have risk of alcohol abuse
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	a. Participants' sociodemographic information and disaster-related situations b. Burn-out Inventory c. PHQ-9 d. AUDIT e. Participants' drinking behavior f. SOCRATES g. Alcohol class evaluation
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	Self control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms	1
Purpose of intervention	Educational,Counseling,Training
Type of intervention	Behavior,custom
Interventions/Control_1	Alchol consumption between pre-post alcohol class
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	20 years-old <=
Age-upper limit	Not applicable
Gender	Male and Female
Key inclusion criteria	Only those that informed consent was obtained
Key exclusion criteria	None
Target sample size	350

Research contact person
Name of lead principal investigator	Maeda, Masaharu
Organization	Fukushima Medical University
Division name	Department of Disaster Psychiatry
Address	Hikarigaoka 1 Fukushima-city, Fukushima
TEL	024-547-1887
Email	masagen@fmu.ac.jp

Public contact
Name of contact person	Ueda, Yuka
Organization	Fukushima Medical University
Division name	Department of Epidemiology
Address	Hikarigaoka 1 Fukushima-city, Fukushima
TEL	024-547-1343
Homepage URL
Email	yukaueda@hotmail.com

Sponsor
Institute	Fukushima Medical University
Institute
Department

Funding Source
Organization	Japan society for the promotion of science
Organization
Division
Category of Funding Organization	Japanese Governmental office
Nationality of Funding Organization

Other related organizations
Co-sponsor
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

Other administrative information
Date of disclosure of the study information	2017 Year 06 Month 06 Day

Progress
Recruitment status	Completed
Date of protocol fixation	2016 Year 05 Month 31 Day
Anticipated trial start date	2016 Year 08 Month 30 Day
Last follow-up date	2016 Year 12 Month 21 Day
Date of closure to data entry	2017 Year 01 Month 10 Day
Date trial data considered complete
Date analysis concluded

Related information
URL releasing protocol
Publication of results	Unpublished
URL releasing results
Results
Other related information

Management information
Registered date	2017 Year 06 Month 06 Day
Last modified on	2017 Year 08 Month 07 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000031684