UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	An examination of the effective coping strategy of mental health for University freshmen: Randomized controlled trial -Hiroshima University GENKI project- (Hug-project)
Title of the study (Brief title)	-Hiroshima University GENKI project-(Hug-project)
Region	Japan

Condition
Condition	subthreshold depression
Classification by specialty	Psychiatry
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	The purpose of study is to whether subthreshold depressive freshmen receiving behavioral activation could demonstrate significant decreases in depressive symptom. Also, the secondary objective of this study is to examine preventive effect of depression and significant change of brain function by carrying out behavioral activation.
Basic objectives2	Efficacy
Basic objectives -Others
Trial characteristics_1	Confirmatory
Trial characteristics_2	Pragmatic
Developmental phase	Not applicable

Assessment
Primary outcomes	BDI-II
Key secondary outcomes	BADS EROS EQ-5D PSQI fMRI SSQ-6

Base
Study type	Interventional

Study design
Basic design	Parallel
Randomization	Randomized
Randomization unit	Individual
Blinding	Open -no one is blinded
Control	No treatment
Stratification	YES
Dynamic allocation
Institution consideration	Institution is not considered as adjustment factor.
Blocking
Concealment	Central registration

Intervention
No. of arms	2
Purpose of intervention	Treatment
Type of intervention	Behavior,custom
Interventions/Control_1	In experimental group, we carry out treatment of behavioral activation. An intervention period is five weeks.
Interventions/Control_2	In control group, we do not carry out treatment. An intervention period is five weeks.
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	18 years-old <=
Age-upper limit	20 years-old >
Gender	Male and Female
Key inclusion criteria	(1) Freshmen in their 18-19 years old in Hiroshima University. (2) Participants who scored 10 or higher on the BDI-II. (3) Participants who were not meeting Diagnostic and Statistical Manual of Mental Disorders-IV(DSM-IV) criteria for depressive disorder in the past 12 months. (4) Participants who got informed consent. (5) Participants who not presently undergoing psychopharmacological, or psychological treatment for depressive disorder.
Key exclusion criteria	(1) Participants who can not understand purpose of the study for serious mental state. (2) Participants who can not endure investigation for serious physical disease. (3) Participants who were meeting Diagnostic and Statistical Manual of Mental Disorders-IV (DSM-IV) criteria for bipolar disorder. (4) Participants who can not carry out MRI examination.
Target sample size	128

Research contact person
Name of lead principal investigator	Shigeto, Yamawaki
Organization	Hiroshima university institute of biomedical and health sciences
Division name	Department of Psychiatry and Neurosciences, Hiroshima University
Address	1-2-3 Kasumi, Minami-ku, Hiroshima
TEL	082-257-5208
Email	yamawaki@hiroshima-u.ac.jp

Public contact
Name of contact person	Ran, Jinnin
Organization	Hiroshima university
Division name	Health service center
Address	1-2-3 Kasumi, Minami-ku, Hiroshima
TEL	082-257-5096
Homepage URL
Email	rjin2n@hiroshima-u.ac.jp

Sponsor
Institute	Department of Psychiatry and Neurosciences, Hiroshima University
Institute
Department

Funding Source
Organization	Ministry of Education, Culture, Sports, Science and Technology
Organization
Division
Category of Funding Organization
Nationality of Funding Organization	Japan

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	2013 Year 10 Month 05 Day

Progress
Recruitment status	Completed
Date of protocol fixation	2013 Year 09 Month 01 Day
Anticipated trial start date	2013 Year 10 Month 01 Day
Last follow-up date
Date of closure to data entry
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	2013 Year 10 Month 05 Day
Last modified on	2018 Year 05 Month 17 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000012851