UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000043596 |
|---|---|
| Receipt number | 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 | 2023/03/13 16:06:41 |
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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 | 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
0799-22-1534
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
a-hayashi@pearl.kobe-u.ac.jp
Sponsor or person
Institute
Kobe University
Institute
Department
Personal name
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
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
| 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
| 2021 | Year | 03 | Month | 11 | Day |
Last modified on
| 2023 | Year | 03 | Month | 13 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000049780
