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Name:
UMIN ID:

Recruitment status Open public recruiting
Unique ID issued by UMIN UMIN000040051
Receipt No. R000045662
Scientific Title Effectiveness of tablet-based cognitive training
Date of disclosure of the study information 2020/04/04
Last modified on 2020/12/23

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Basic information
Public title Effectiveness of tablet-based cognitive training
Acronym Effectiveness of tablet-based cognitive training
Scientific Title Effectiveness of tablet-based cognitive training
Scientific Title:Acronym Effectiveness of tablet-based cognitive training
Region
Japan

Condition
Condition Mood disorder
Anxiety disorder
Autism spectrum disorder
Attention deficit hyperactivity disorder
Mild cognitive impairment
Normal healthy control
Classification by specialty
Psychiatry
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 Cognitive training has been thought to be a potential method to improve cognitive function. This training aims to maintain and improve cognitive function by repeatedly performing task (training) that requires cognitive function. Many cognitive training methods have been proposed, including working memory training, processing speed training, memory strategy training, reading and calculation training, and brain training games.

However, there are several issues in these traditional cognitive trainings. For instance, people need to purchase specialized and expensive equipment for the training . Participants have to visit universities and facilities with specialized staff. We thus need to develop cognitive training that has low implementation costs and can be easily implemented by anyone.

Cognitive training using smartphones and tablets may be attractive. Huge advantage over traditional training is that you can use the devices you are already using on a daily life and feel free to work at home at any time. Based on these social situation, we believe that examining the effects of cognitive training by using a tablet is of great social significance.

Therefore, in this study, we aimed to establish the usefulness of tablet-based cognitive training for psychiatric disorders.
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes 1 Clinical evaluation scale
HAM-D, HAM-A, MADRAS, etc.

2 Neuropsychological examination
TMT, BADS, CAT, CANTAB, etc.
Key secondary outcomes

Base
Study type Interventional

Study design
Basic design Single arm
Randomization Non-randomized
Randomization unit
Blinding Open -no one is blinded
Control Self control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms 1
Purpose of intervention Treatment
Type of intervention
Other
Interventions/Control_1 We conduct a maximum of 20 cognitive training at a pace of 4-5 days per week.
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
20 years-old <=
Age-upper limit
85 years-old >=
Gender Male and Female
Key inclusion criteria 1 Patient group
People who were diagnosed with mood disorder, anxiety disorder, ASD, ADHD, MCI in DSM-5

2 Healthy control group
A healthy person without a history of mental illness
Key exclusion criteria People who satisfies one of the following

1 Combined circulatory organ, liver, kidney, respiratory organs, blood, endocrine, central nervous system diseases, and person who was judged to be extremely unstable
2 Person who has history of head trauma or substance dependence
3 People with a history of epilepsy or generalized convulsions
4 For healthy control subjects, those who are diagnosed with developmental disorder
Target sample size 150

Research contact person
Name of lead principal investigator
1st name Bun
Middle name
Last name Yamagata
Organization Keio University School of Medicine
Division name Department of Neuropsychiatry
Zip code 160-8582
Address 35 Shinanomachi Shinjuku-Ku, Tokyo
TEL 03-5363-3971
Email yamagata@a6.keio.jp

Public contact
Name of contact person
1st name Bun
Middle name
Last name Yamagata
Organization Keio University School of Medicine
Division name Department of Neuropsychiatry
Zip code 160-8582
Address 35 Shinanomachi Shinjuku-Ku, Tokyo
TEL 03-5363-3971
Homepage URL
Email yamagata@a6.keio.jp

Sponsor
Institute Keio University
Institute
Department

Funding Source
Organization None
Organization
Division
Category of Funding Organization Self funding
Nationality of Funding Organization

Other related organizations
Co-sponsor
Name of secondary funder(s)

IRB Contact (For public release)
Organization Keio University School of Medicine, Institutional Review Board
Address 35 Shinanomachi Shinjuku-Ku, Tokyo
Tel 03-5363-3503
Email med-rinri-jimu@adst.keio.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
2020 Year 04 Month 04 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 Open public recruiting
Date of protocol fixation
2020 Year 03 Month 30 Day
Date of IRB
2020 Year 03 Month 30 Day
Anticipated trial start date
2020 Year 04 Month 04 Day
Last follow-up date
2025 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
2020 Year 04 Month 04 Day
Last modified on
2020 Year 12 Month 23 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000045662

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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