UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000032839 |
|---|---|
| Receipt number | 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 | 2022/12/06 15:12:11 |
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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
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
orange.mi310to@gmail.com
Sponsor or person
Institute
Kohnodai Hospital, National Center for Global Health and Medicine
Institute
Department
Personal name
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
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
http://www.ncgmkohnodai.go.jp/nurse/190/opt50018010101.pdf
Publication of results
Partially published
Result
URL related to results and publications
http://www.ncgmkohnodai.go.jp/nurse/190/opt50018010102.pdf
Number of participants that the trial has enrolled
46
Results
The subjects were 36 (18 males and 18 females), and the average age was 45.0years. The hint task changed at r = .78 (p <.01).TMT-B changed at r = .57 (p <.01), and Backward Digit Span changed at r = .40 (p <.05).
LASMI-I changed at r = .83 (p <.01) and SBS changed at r = .76 (p <.01). Social and interpersonal functions have improved objectively. However, the Social Skills Self-rating Scale for Adults did not show any significant changes. Interpersonal function did not improve subjectively.
Results date posted
| 2020 | Year | 12 | Month | 16 | Day |
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
Inpatients with schizophrenia who were 20 to 65 years old in a psychiatric acute care ward participated. Those with a history of organic brain disease and substance abuse, intellectual disability, autism spectrum disorder, dementia, and those with severe disassembly symptoms were excluded.
Participant flow
Participants received informed consent for this study and agreed with the purpose of this study. Pre-intervention evaluation was performed 3 days prior to an intervention. Participants received an intervention program once or twice a week. Post-intervention evaluation was performed 1 week after an intervention.
Adverse events
No adverse events
Outcome measures
False-belief task (Parner,Wimmer,1985)
Hinting tasks (Corcoran et al., 1995)
Trail Making Test Part B (Kashima et al.,1986)
Backward Digit Span
Social Behavior Schedule (Wykes and Sturt, 1986)
Life Assessment Scale for the Mentally Ill (Iwasaki et al., 1994)
Social Skills Self-rating Scale for Adults (Aikawa and Fujita, 2005)
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
| 2022 | Year | 12 | Month | 06 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000037452
| Research Plan | |
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| Registered date | File name |
| Research case data | |
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