UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000034354 |
|---|---|
| Receipt number | R000039164 |
| Scientific Title | Game-based computerized cognitive behavioral therapy for Japanese university students with depressive symptom |
| Date of disclosure of the study information | 2018/10/03 |
| Last modified on | 2021/06/28 13:05:52 |
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Basic information
Public title
Game-based computerized cognitive behavioral therapy for Japanese university students with depressive symptom
Acronym
Game-based computerized cognitive behavioral therapy for Japanese university students with depressive symptom
Scientific Title
Game-based computerized cognitive behavioral therapy for Japanese university students with depressive symptom
Scientific Title:Acronym
Game-based computerized cognitive behavioral therapy for Japanese university students with depressive symptom
Region
| Japan |
Condition
Condition
University students facing with mild-to-moderate depressive symptom
Classification by specialty
| Not applicable |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
The purpose of this study is to test the effectiveness of the game- based computerized cognitive behavioral therapy for depressive symptom among university students.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Confirmatory
Trial characteristics_2
Developmental phase
Not applicable
Assessment
Primary outcomes
Depressive symptom
Key secondary outcomes
Outcome measure (satisfaction with life, social function, and mood states)
Process measure (rumination, coping)
Other (perceived helpfulness, satisfaction with use, the depth of understanding)
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Open -no one is blinded
Control
No treatment
Stratification
NO
Dynamic allocation
Institution consideration
Institution is considered as a block.
Blocking
YES
Concealment
No need to know
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Behavior,custom | Other |
Interventions/Control_1
game-based computerized cognitive behavioral therapy (SPARX: smart, positive, active, realistic, X-factor thoughts)
Interventions/Control_2
Waiting-list
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
| 30 | years-old | > |
Gender
Male and Female
Key inclusion criteria
Depressive symptoms are mild or moderate (16 <= CES-D <= 45)
Gives full informed consent to participate in the study
Key exclusion criteria
At high risk of self-harm or suicide at baseline
Depressive symptoms are severe (CES-D > 45)
Current manic episode or current schizophrenia or other psychotic disorder at baseline reported from participants
Experience using the SPARX
Other relevant reason as determined by the researchers
Target sample size
100
Research contact person
Name of lead principal investigator
| 1st name | Kengo |
| Middle name | |
| Last name | Yokomitsu |
Organization
Ritsumeikan University
Division name
College of Comprehensive Psychology
Zip code
567-8570
Address
2-150, Iwakura-cho, Ibaraki, Osaka 560-8570, Japan
TEL
072-665-2490
k-yoko@fc.ritsumei.ac.jp
Public contact
Name of contact person
| 1st name | Kengo |
| Middle name | |
| Last name | Yokomitsu |
Organization
Ritsumeikan University
Division name
College of Comperhensive Psychology
Zip code
567-8570
Address
2-150, Iwakura-cho, Ibaraki, Osaka 560-8570, Japan
TEL
072-665-2490
Homepage URL
k-yoko@fc.ritsumei.ac.jp
Sponsor or person
Institute
Ritsumeikan University
Institute
Department
Personal name
Funding Source
Organization
The Research Institute of Personalized Health Sciences, Health Sciences University of Hokkaido
Organization
Division
Category of Funding Organization
Other
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
1
Address
1
Tel
0775613488
b-rinri@st.ritsumei.ac.jp
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
立命館大学（大阪府）、北海道医療大学（北海道）、北翔大学（北海道）、その他インターネットで募集
Other administrative information
Date of disclosure of the study information
| 2018 | Year | 10 | Month | 03 | 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
| 2018 | Year | 10 | Month | 01 | Day |
Date of IRB
| 2018 | Year | 09 | Month | 25 | Day |
Anticipated trial start date
| 2019 | Year | 04 | Month | 01 | Day |
Last follow-up date
| 2021 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
| 2021 | Year | 05 | Month | 31 | Day |
Date trial data considered complete
| 2021 | Year | 06 | Month | 28 | Day |
Date analysis concluded
Other
Other related information
None
Management information
Registered date
| 2018 | Year | 10 | Month | 02 | Day |
Last modified on
| 2021 | Year | 06 | Month | 28 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000039164
| Research Plan | |
|---|---|
| Registered date | File name |
| Research case data specifications | |
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| Registered date | File name |
| Research case data | |
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| Registered date | File name |
