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Name:
UMIN ID:

Recruitment status Enrolling by invitation
Unique ID issued by UMIN UMIN000039521
Receipt No. R000045042
Scientific Title Cognitive training for schizophrenia: a randomized controlled trial
Date of disclosure of the study information 2020/02/18
Last modified on 2021/03/11

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Basic information
Public title Cognitive training for schizophrenia: a randomized controlled trial
Acronym Cognitive training for schizophrenia: a randomized controlled trial
Scientific Title Cognitive training for schizophrenia: a randomized controlled trial
Scientific Title:Acronym Cognitive training for schizophrenia: a randomized controlled trial
Region
Japan

Condition
Condition Schizophrenia
Classification by specialty
Psychiatry Rehabilitation medicine
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 To evaluate effects of cognitive training for schizophrenia
Basic objectives2 Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes Brief Assessment of Cognition in Schizophrenia (BACS)
Key secondary outcomes Schizophrenia Cognition Rating Scale (SCoRS)
Intrinsic motivation inventory (IMI)
Quality of Life Scale (QLS)
Positive and Negative Syndrome Scale (PANSS)
Scale for the Assessment of Negative Symptoms (SANS)
Global Assessment of Functioning (GAF)

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
Behavior,custom
Interventions/Control_1 Cognitive training. 12 weeks, 2 computer and 1 group meeting sessions/week.
Interventions/Control_2 Treatment as usual
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 schizophrenia or schizoaffective disorder based on DSM-5
Key exclusion criteria mental retardation; alcohol or drug dependence; history of neurological disorders
Target sample size 86

Research contact person
Name of lead principal investigator
1st name Masayoshi
Middle name
Last name Kobayashi
Organization Shinshu University
Division name School of Health Sciences, Faculty of Medicine
Zip code 396-8621
Address 3-1-1, Asahi, Matsumoto, Nagano, Japan
TEL 0263-37-2403
Email mkobaya@shinshu-u.ac.jp

Public contact
Name of contact person
1st name Ayumi
Middle name
Last name Yamanushi
Organization Medical Corporation Seitaikai Mental Support Soyokaze Hospital
Division name Department of Rehabilitation
Zip code 386-0401
Address 3057-1, Shiogawa, Ueda, Nagano, Japan
TEL 0268-35-0305
Homepage URL
Email ot@seitaikai.or.jp

Sponsor
Institute Shinshu 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 Shinshu University
Address 3-1-1, Asahi, Matsumoto, Nagano, Japan
Tel 0263-37-2572
Email mdrinri@shinshu-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 医療法人清泰会メンタルサポートそよかぜ病院(長野県)

Other administrative information
Date of disclosure of the study information
2020 Year 02 Month 18 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
2020 Year 02 Month 04 Day
Date of IRB
2020 Year 02 Month 04 Day
Anticipated trial start date
2020 Year 02 Month 18 Day
Last follow-up date
2022 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 02 Month 18 Day
Last modified on
2021 Year 03 Month 11 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000045042

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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