UMIN-CTR Clinical Trial

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