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UMIN ID:

Recruitment status Terminated
Unique ID issued by UMIN UMIN000027292
Receipt No. R000031259
Scientific Title 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)
Date of disclosure of the study information 2017/05/10
Last modified on 2018/04/28

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Basic information
Public title 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)
Acronym -Hiroshima University GENKI project-(Hug-project)
Scientific Title 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)
Scientific Title:Acronym -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
1st name
Middle name
Last name Yasumasa Okamoto
Organization Graduate School of Biomedical and Health Sciences, Hiroshima University
Division name Department of Psychiatry and Neurosciences, Hiroshima University
Zip code
Address 1-2-3 Kasumi, Minami-ku, Hiroshima
TEL 082-257-5208
Email oy@hiroshima-u.ac.jp

Public contact
Name of contact person
1st name
Middle name
Last name Koki Takagaki
Organization Graduate School of Biomedical and Health Sciences, Hiroshima University
Division name Department of Psychiatry and Neurosciences
Zip code
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)

IRB Contact (For public release)
Organization
Address
Tel
Email

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

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 Terminated
Date of protocol fixation
2017 Year 04 Month 27 Day
Date of IRB
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

Other
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/ctr_e/ctr_view.cgi?recptno=R000031259

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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