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Name:
UMIN ID:

Recruitment status Enrolling by invitation
Unique ID issued by UMIN UMIN000043596
Receipt No. R000049780
Scientific Title Effects of metacognitive training on self-efficacy and cognitive function in schizophrenia
Date of disclosure of the study information 2021/03/15
Last modified on 2021/03/18

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Basic information
Public title Effects of metacognitive training on self-efficacy and cognitive function in schizophrenia
Acronym Intervention study of metacognitive training by schizophrenia
Scientific Title Effects of metacognitive training on self-efficacy and cognitive function in schizophrenia
Scientific Title:Acronym Intervention study of metacognitive training by schizophrenia
Region
Japan

Condition
Condition schizophrenia
Classification by specialty
Psychiatry
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 To evaluate effects of the Japanese vertion of metacognitive training on positive symptons and cognitive function,self-efficacy.
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes PANSS
self-efficacy
Key secondary outcomes cognitive function

Base
Study type Interventional

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

Intervention
No. of arms 2
Purpose of intervention Educational,Counseling,Training
Type of intervention
Behavior,custom
Interventions/Control_1 MCT group
Interventions/Control_2 waitlist group
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

Not applicable
Age-upper limit

Not applicable
Gender Male and Female
Key inclusion criteria 1)Patient with schizophrenia diagnosed according to DSM-V or ICD-10 criteria
2)Subjects who can communicate in language
3)Subjects who can continue to participate
Key exclusion criteria 1)Subjects with mental retardation, personality disorder, pervasive developmental disorder, dementia, cerebrovascular disorder
2)Subjects with organic brain damage, sensory impairment, parkinsonism, or other neurological symptom
3)Subjects with drug abuse
4)Subjects with the PANSS hostility score of 5 or higher and paranoia and suspicion score of 6 or 7
Target sample size 50

Research contact person
Name of lead principal investigator
1st name kanae
Middle name
Last name Kuroda
Organization Kobe University
Sinawaji Hospital
Division name Graduate School of Health Sciences
Zip code 654-0142
Address 7-10-2 Tomogaoka, Suma-ku, Kobe, Japan
TEL 0799-22-1534
Email 174k253k@stu.kobe-u.ac.jp

Public contact
Name of contact person
1st name atsuko
Middle name
Last name Hayashi
Organization Kobe University
Division name Graduate School of Health Sciences
Zip code 654-0142
Address 7-10-2 Tomogaoka, Suma-ku, Kobe, Japan
TEL 078-792-2555
Homepage URL
Email a-hayashi@pearl.kobe-u.ac.jp

Sponsor
Institute Kobe University
Institute
Department

Funding Source
Organization Kobe University
Grant-in-Aid for Scientific Research
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 Kobe University Graduate School of Health Sciences
Address 7-10-2 Tomogaoka, Suma-ku, Kobe, Japan
Tel 078-792-2555
Email a-hayashi@pearl.kobe-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 医療法人新淡路病院

Other administrative information
Date of disclosure of the study information
2021 Year 03 Month 15 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 10 Day
Date of IRB
2020 Year 02 Month 20 Day
Anticipated trial start date
2021 Year 03 Month 15 Day
Last follow-up date
2023 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
2021 Year 03 Month 11 Day
Last modified on
2021 Year 03 Month 18 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000049780

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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