UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000018221 |
|---|---|
| Receipt number | R000020484 |
| Scientific Title | An examination of the effective coping strategy of depressive symptoms for university freshmen: Open trial -Hiroshima University GENKI project- (Hug-project) |
| Date of disclosure of the study information | 2015/07/08 |
| Last modified on | 2018/05/17 17:38:40 |
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Basic information
Public title
An examination of the effective coping strategy of depressive symptoms for university freshmen: Open trial -Hiroshima University GENKI project- (Hug-project)
Acronym
Hiroshima University GENKI project- (Hug-project)
Scientific Title
An examination of the effective coping strategy of depressive symptoms for university freshmen: Open trial -Hiroshima University GENKI project- (Hug-project)
Scientific Title:Acronym
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
| 1st name | |
| Middle name | |
| Last name | Yasumasa Okamoto |
Organization
Hiroshima university institute of biomedical and health sciences
Division name
Department of Psychiatry and Neurosciences
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
Hiroshima university institute of biomedical and health sciences
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, Hiroshima University
Institute
Department
Personal name
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)
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
| 2015 | Year | 07 | Month | 08 | 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
Completed
Date of protocol fixation
| 2015 | Year | 07 | Month | 01 | Day |
Date of IRB
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
Other
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000020484
