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Name:
UMIN ID:

Recruitment status No longer recruiting
Unique ID issued by UMIN UMIN000032839
Receipt No. R000037452
Scientific Title Effect of the Theory of Mind and working memory program for the patients with schizophrenia during hospitalization
Date of disclosure of the study information 2018/06/01
Last modified on 2020/06/11

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Basic information
Public title Effect of the Theory of Mind and working memory program for the patients with schizophrenia during hospitalization
Acronym Effect of the Theory of Mind and working memory program for the patients with schizophrenia during hospitalization
Scientific Title Effect of the Theory of Mind and working memory program for the patients with schizophrenia during hospitalization
Scientific Title:Acronym Effect of the Theory of Mind and working memory program for the patients with schizophrenia during hospitalization
Region
Japan

Condition
Condition Schizophrenia
Classification by specialty
Psychiatry Nursing
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 To reveal an effect of the Theory of Mind and working memory program for the patients with schizophrenia
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes Theory of Mind and working memory one week after the end of the program
Key secondary outcomes Social function and interpersonal function one week after the end of the program

Base
Study type Interventional

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

Intervention
No. of arms 1
Purpose of intervention Educational,Counseling,Training
Type of intervention
Behavior,custom
Interventions/Control_1 Participants to the program
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
65 years-old >
Gender Male and Female
Key inclusion criteria In-patients in psychiatric unit
Key exclusion criteria People with history of brain disease and drug abuse
People with intellectual disability and autism spectrum disorder
Target sample size 40

Research contact person
Name of lead principal investigator
1st name Mio
Middle name
Last name Sato
Organization Kohnodai Hospital, National Center for Global Health and Medicine
Division name Nursing division
Zip code 272-8516
Address 1-7-1, Kohnodai, Ichikawa, Chiba, 272-8516, Japan
TEL 047-372-3501
Email orange.mi310to@gmail.com

Public contact
Name of contact person
1st name Mio
Middle name
Last name Sato
Organization Kohnodai Hospital, National Center for Global Health and Medicine
Division name Nursing division
Zip code 272-8516
Address 1-7-1, Kohnodai, Ichikawa, Chiba, 272-8516, Japan
TEL 047-372-3501
Homepage URL
Email orange.mi310to@gmail.com

Sponsor
Institute Kohnodai Hospital, National Center for Global Health and Medicine
Institute
Department

Funding Source
Organization Kohnodai Hospital, National Center for Global Health and Medicine
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 Kohnodai Hospital, National Center for Global Health and Medicine
Address 1-7-1, Kohnodai, Ichikawa, Chiba, 272-8516, Japan
Tel 047-372-3501
Email orange.mi310to@gmail.com

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 国立国際医療研究センター国府台病院(千葉県)

Other administrative information
Date of disclosure of the study information
2018 Year 06 Month 01 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 No longer recruiting
Date of protocol fixation
2017 Year 08 Month 17 Day
Date of IRB
2017 Year 10 Month 10 Day
Anticipated trial start date
2017 Year 11 Month 30 Day
Last follow-up date
2018 Year 10 Month 11 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
2018 Year 06 Month 03 Day

Other
Other related information

Management information
Registered date
2018 Year 06 Month 01 Day
Last modified on
2020 Year 06 Month 11 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000037452

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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