UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	An examination of the effective coping strategy of depressive symptoms for university freshmen: Open trial -Hiroshima University GENKI project- (Hug-project)
Title of the study (Brief title)	Hiroshima University GENKI project- (Hug-project)
Region	Japan

Condition
Condition	Major Depressive Disorder
Classification by specialty	Psychiatry
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	The purpose of this study is to whether behavioral activation program of university students could demonstrate significant decrease in depressive symptoms. Also, this study is to examine significant change of brain function from pre-treatment to post-treatment.
Basic objectives2	Efficacy
Basic objectives -Others
Trial characteristics_1	Exploratory
Trial characteristics_2	Pragmatic
Developmental phase

Assessment
Primary outcomes	Beck Depression Inventory-II
Key secondary outcomes	Behavioral Activation for Depression Scale, Environmental Reward Observation Scale, Euro QolEQ-5-D,Generalized Self-Efficacy Scale,Effortful Control.

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	Treatment
Type of intervention	Behavior,custom
Interventions/Control_1	Behavioral activation
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	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) Freshmen were diagnosed with Major Depressive disorders and judged to be able to receive counseling treatment in health service center (3) Participants who got informed consent. (4) Participants who scored 18 or higher on the BDI-II.
Key exclusion criteria	(1)Participants who presently undergoing psychopharmacological, or psychological treatment for depressive disorder. (2) Participants who can not understand purpose of the study for serious mental state. (3) Participants who can not endure investigation for serious physical disease. (4) Participants who were meeting Diagnostic and Statistical Manual of Mental Disorders-IV (DSM-IV) criteria for bipolar disorder. (5) Participants who can not carry out MRI examination.
Target sample size	12

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

Public contact
Name of contact person	Koki Takagaki
Organization	Hiroshima university institute of biomedical and health sciences
Division name	Department of Psychiatry and Neurosciences
Address	1-2-3 Kasumi, Minami-ku, Hiroshima
TEL	082-257-5208
Homepage URL
Email	koki.takagaki@gmail.com

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

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	2015 Year 07 Month 08 Day

Progress
Recruitment status	Completed
Date of protocol fixation	2015 Year 07 Month 01 Day
Anticipated trial start date	2015 Year 07 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	2015 Year 07 Month 07 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=R000020484