UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000027292 |
|---|---|
| Receipt number | 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 11:04:31 |
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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
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
koki.takagaki@gmail.com
Sponsor or person
Institute
Department of Psychiatry and Neurosciences, Graduate School of Biomedical and Health Sciences, Hiroshima University
Institute
Department
Personal name
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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000031259
