UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000057101 |
|---|---|
| Receipt number | R000065265 |
| Scientific Title | Validation of hybrid type cognitive rehabilitation program to people with schizophrenia using tablet devices |
| Date of disclosure of the study information | 2025/02/21 |
| Last modified on | 2026/06/09 12:21:15 |
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Basic information
Public title
Validation of hybrid type cognitive rehabilitation program to people with schizophrenia using tablet devices
Acronym
Validation of hybrid type cognitive rehabilitation program to people with schizophrenia using tablet devices
Scientific Title
Validation of hybrid type cognitive rehabilitation program to people with schizophrenia using tablet devices
Scientific Title:Acronym
Validation of hybrid type cognitive rehabilitation program to people with schizophrenia using tablet devices
Region
| Japan |
Condition
Condition
schizophrenia
Classification by specialty
| Psychiatry |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
Establishment of a rehabilitation program that combines face-to-face and home-based learning using the tablet version of Jcores (Japanese Cognitive Rehabilitation Programme for Schizophrenia), a software program for cognitive rehabilitation for people with schizophrenia, and verification of its non-inferiority compared to a program using the PC version of Jcores
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
(1)Dropout rate from the program
(2)BACS-J: the Brief Assessment of Cognition in Schizophrenia Japanese Version
(3)PANSS: Positive and Negative Syndrome Scale Japanese Version
(4)SLOF: Specific Levels of Functioning Scale Japanese Version
(5)CSQ-8J: Client Satisfaction Questionnaire
(6)IMI: Intrinsic Motivation Inventory
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Open -but assessor(s) are blinded
Control
Active
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Other |
Interventions/Control_1
A rehabilitation program that combines face-to-face and home-based learning using the tablet version of Jcores (Japanese Cognitive Rehabilitation Programme for Schizophrenia) software: The subjects will visit the treatment center once a week for a total of 12 weeks. They will receive remote training using computer games at home for one hour a week, and will visit the treatment center once a week for one hour of computer game training and one hour of group meeting sessions.
Interventions/Control_2
Rehabilitation program using Jcores (Japanese Cognitive Rehabilitation Programme for Schizophrenia), PC-based cognitive rehabilitation software: The subjects will visit the treatment center twice a week for a total of 12 weeks. One of these visits will consist of one hour of computer game training only, and the other will consist of one hour of computer game training and one hour of group meeting sessions.
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
| 20 | years-old | <= |
Age-upper limit
| 60 | years-old | > |
Gender
Male and Female
Key inclusion criteria
Those who are diagnosed with schizophrenia (F20 in ICD-10: International Classification of Diseases, 10th Revision) and are receiving outpatient treatment
Key exclusion criteria
(1)Substance or alcohol use disorder
(2)Intellectual disability
(3)History of brain organic disease, head injury, disturbance of consciousness, epilepsy, or central nervous system disease
Target sample size
48
Research contact person
Name of lead principal investigator
| 1st name | Tsubasa |
| Middle name | |
| Last name | Morimoto |
Organization
Nara Medical University
Division name
Department of Psychiatry
Zip code
6348522
Address
840 Shijo-cho, Kashihara, Nara, Japan
TEL
+81-744-22-3051
tsubasa@naramed-u.ac.jp
Public contact
Name of contact person
| 1st name | Tsubasa |
| Middle name | |
| Last name | Morimoto |
Organization
Nara Medical University
Division name
Department of Psychiatry
Zip code
6348522
Address
840 Shijo-cho, Kashihara, Nara, Japan
TEL
+81-744-22-3051
Homepage URL
tsubasa@naramed-u.ac.jp
Sponsor or person
Institute
other
Institute
Department
Personal name
Funding Source
Organization
none
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
Nara Medical University
Address
840 Shijo-cho, Kashihara, Nara, Japan
Tel
+81-744-22-3051
ino_rinri@naramed-u.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
Other administrative information
Date of disclosure of the study information
| 2025 | Year | 02 | Month | 21 | 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
0
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
| 2024 | Year | 02 | Month | 13 | Day |
Date of IRB
| 2024 | Year | 02 | Month | 13 | Day |
Anticipated trial start date
| 2025 | Year | 04 | Month | 01 | Day |
Last follow-up date
| 2026 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2025 | Year | 02 | Month | 21 | Day |
Last modified on
| 2026 | Year | 06 | Month | 09 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000065265
