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Name:
UMIN ID:

Recruitment status Enrolling by invitation
Unique ID issued by UMIN UMIN000034354
Receipt No. 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 2019/06/14

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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
Email 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
Email k-yoko@fc.ritsumei.ac.jp

Sponsor
Institute Ritsumeikan University
Institute
Department

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
Email 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 Enrolling by invitation
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
2020 Year 03 Month 31 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information None

Management information
Registered date
2018 Year 10 Month 02 Day
Last modified on
2019 Year 06 Month 14 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000039164

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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