UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000011967 |
|---|---|
| Receipt number | R000012851 |
| Scientific Title | An examination of the effective coping strategy of mental health for University freshmen: Randomized controlled trial -Hiroshima University GENKI project- (Hug-project) |
| Date of disclosure of the study information | 2013/10/05 |
| Last modified on | 2018/05/17 17:47:02 |
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Basic information
Public title
An examination of the effective coping strategy of mental health for University freshmen: 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: Randomized controlled trial -Hiroshima University GENKI project- (Hug-project)
Scientific Title:Acronym
-Hiroshima University GENKI project-(Hug-project)
Region
| Japan |
Condition
Condition
subthreshold depression
Classification by specialty
| Psychiatry |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
The purpose of study is to whether subthreshold depressive freshmen receiving behavioral activation could demonstrate significant decreases in depressive symptom. Also, the secondary objective of this study is to examine preventive effect of depression 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
BDI-II
Key secondary outcomes
BADS
EROS
EQ-5D
PSQI
fMRI
SSQ-6
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Open -no one is blinded
Control
No treatment
Stratification
YES
Dynamic allocation
Institution consideration
Institution is not considered as adjustment factor.
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 treatment of behavioral activation.
An intervention period is five weeks.
Interventions/Control_2
In control group, we do not carry out treatment.
An intervention period is five weeks.
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) Participants who scored 10 or higher on the BDI-II.
(3) Participants who were not meeting Diagnostic and Statistical Manual of Mental Disorders-IV(DSM-IV) criteria for depressive disorder in the past 12 months.
(4) Participants who got informed consent.
(5) Participants who not presently undergoing psychopharmacological, or psychological treatment for depressive disorder.
Key exclusion criteria
(1) Participants who can not understand purpose of the study for serious mental state.
(2) Participants who can not endure investigation for serious physical disease.
(3) Participants who were meeting Diagnostic and Statistical Manual of Mental Disorders-IV (DSM-IV) criteria for bipolar disorder.
(4) Participants who can not carry out MRI examination.
Target sample size
128
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Shigeto, Yamawaki |
Organization
Hiroshima university institute of biomedical and health sciences
Division name
Department of Psychiatry and Neurosciences, Hiroshima University
Zip code
Address
1-2-3 Kasumi, Minami-ku, Hiroshima
TEL
082-257-5208
yamawaki@hiroshima-u.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Ran, Jinnin |
Organization
Hiroshima university
Division name
Health service center
Zip code
Address
1-2-3 Kasumi, Minami-ku, Hiroshima
TEL
082-257-5096
Homepage URL
rjin2n@hiroshima-u.ac.jp
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
Japan
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
| 2013 | Year | 10 | Month | 05 | 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
| 2013 | Year | 09 | Month | 01 | Day |
Date of IRB
Anticipated trial start date
| 2013 | Year | 10 | 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
| 2013 | Year | 10 | Month | 05 | 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=R000012851
