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 with major depressive episode: 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	depression
Classification by specialty	Psychiatry
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	The purpose of study is to whether university freshmen with major depressive episode receiving behavioral activation could demonstrate significant decreases in depressive symptom. Also, the secondary objective of this study is to examine long-term (1 year) effect of depressive symptoms 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	Beck Depression Inventory (BDI)- II
Key secondary outcomes	1) Patient Health Questionnare-9(PHQ-9) 2) (GRID-Hamilton Depression Rating Scale(GRID-HAM-D) 3) Behavioral Activation for Depression Scale(BADS) 4) Environmental Reward Observation Scale(EROS) EuroQol scale(EQ-5D) 6) Personal Values Questionnaire II(PVQ-II) 7) Valuing Questionnaire(VQ) 8) Generalized Self-Efficacy Scale(SE) 9) Eating Attitudes Test(EAT) 10) Bulimic Investigatory Test, Edinburgh(BITE) 11) fMRI 12) Behavior / physiological examination

Base
Study type	Interventional

Study design
Basic design	Parallel
Randomization	Randomized
Randomization unit	Individual
Blinding	Open -no one is blinded
Control	Active
Stratification	YES
Dynamic allocation
Institution consideration
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 care as usual and behavioral activation. Treatment of behavioral activation consisted of 10 weekly 60-min sessions.
Interventions/Control_2	In control group, we carry out care as usual.
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) University freshmen in their 18-19 years old in Hiroshima University (2) University freshmen who scored 18 or higher on the BDI-II (3) University freshmen were diagnosed with Major Depressive episode and judged to be able to receive counseling treatment in health service center (4) University freshmen who were meeting Diagnostic and Statistical Manual of Mental Disorders-IV (DSM-IV) criteria for Major Depressive episode (5) University freshmen who got informed consent of participation of study and recording session contents (6) University freshmen who have been able to live a university life as usual by a psychiatrist's diagnosis
Key exclusion criteria	(1) Apart from care as usual at the Health Service Center, University Freshmen who currently receiving medication and psychotherapy for treatment (2) University freshmen who can not understand purpose of the study for serious mental state (3) University freshmen who can not endure investigation for serious physical disease (4)University freshmen who were meeting Diagnostic and Statistical Manual of Mental Disorders-IV (DSM-IV) criteria for bipolar disorder
Target sample size	52

Research contact person
Name of lead principal investigator	Yasumasa Okamoto
Organization	Graduate School of Biomedical and Health Sciences, Hiroshima University
Division name	Department of Psychiatry and Neurosciences, Hiroshima University
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	Graduate School of Biomedical and Health Sciences, Hiroshima University
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, Graduate School of Biomedical and Health Sciences, Hiroshima University
Institute
Department

Funding Source
Organization	Japan Society for the Promotion of Science (JSPS), Grant-in-Aid for Scientific Research (KAKENHI)
Organization
Division
Category of Funding Organization	Non profit foundation
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 05 Month 10 Day

Progress
Recruitment status	Terminated
Date of protocol fixation	2017 Year 04 Month 27 Day
Anticipated trial start date	2017 Year 09 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	2017 Year 05 Month 10 Day
Last modified on	2018 Year 04 Month 28 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000031259