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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000034106
Receipt No. R000038868
Scientific Title Effectiveness of metacognitive training for schizophrenic patients: Randomized controlled trial
Date of disclosure of the study information 2021/06/30
Last modified on 2021/02/10

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Basic information
Public title Effectiveness of metacognitive training for schizophrenic patients: Randomized controlled trial
Acronym Metacognitive training for schizophrenic patients
Scientific Title Effectiveness of metacognitive training for schizophrenic patients: Randomized controlled trial
Scientific Title:Acronym Metacognitive training for schizophrenic patients
Region
Japan

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

Objectives
Narrative objectives1 Verify the effect of metacognitive training on schizophrenic patients
Basic objectives2 Others
Basic objectives -Others Search for factors predicting recurrence (re-hospitalization) one year after discharge.
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes Score change of The Brief Assessment of Cognition in Schizophrenia 3 months after treatment start or discharge
Key secondary outcomes Score change of Positive and Negative Syndrome Scale 3 months after treatment start or discharge

Base
Study type Interventional

Study design
Basic design Parallel
Randomization Randomized
Randomization unit Individual
Blinding Open -no one is blinded
Control Placebo
Stratification YES
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms 2
Purpose of intervention Educational,Counseling,Training
Type of intervention
Other
Interventions/Control_1 During the hospital stay for a few months, metacognitive training (MCT) will be conducted twice a week, 16 times in total, in addition to usual occupational therapy.
Interventions/Control_2 A usual occupational therapy will be carried out during the hospitalization period of a few months.
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 1) Person who is in hospital in psychiatric hospital.
2) Persons diagnosed with schizophrenia or schizophrenia affective disorder.
3) Person who prescribed occupational therapy from the attending physician.
4) After receiving sufficient explanation for the participation of this research, those who gained written consent based on the free will of the patient himself / herself.
Key exclusion criteria 1) Person who is under 20 years old or over 65 years old.
2) Persons who have mergers such as intellectual disability, alcohol / drug dependence (substance abuse / dependence), dementia, epilepsy, head trauma, cerebrovascular disease etc.
3) Persons who are unstable in medical condition and have difficulty performing MCT or cognitive function test.
4) Persons who have not received occupational therapy.
5) Persons who can not obtain consent to participate in research.
6) Person who judged that the doctor or research director is ineligible.
Target sample size 46

Research contact person
Name of lead principal investigator
1st name Masayoshi
Middle name
Last name Kobayashi
Organization Shinshu University
Division name Graduate School of Health Science
Zip code 390-8621
Address Matsumoto
TEL 0263372403
Email mkobaya@shinshu-u.ac.jp

Public contact
Name of contact person
1st name Masayoshi
Middle name
Last name Kobayashi
Organization Shinshu University Graduate School of Health Science
Division name Division of Occupational Therapy
Zip code 390-8621
Address Matsumoto
TEL 0263372403
Homepage URL
Email mkobaya@shinshu-u.ac.jp

Sponsor
Institute Tikumaso Mental Hospital
Institute
Department

Funding Source
Organization Shinshu University
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 Shinshu University Graduate School of Medicine
Address 3-1-1
Tel 0263372403
Email mkobaya@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

Other administrative information
Date of disclosure of the study information
2021 Year 06 Month 30 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 24
Results Post evaluation showed significant improvement in BACS Verbal fluency, Executive function, and Composite score, but two-way ANOVA did not show any interaction. In PANSS, positive and negative symptoms were significantly reduced, and time x group interaction was observed in general pathology. In BCIS, self-reflection in the OT + IMI group tended to improve, but there was no difference between the groups and the interaction was small.
Results date posted
2021 Year 02 Month 10 Day
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics Among schizophrenia patients admitted to the psychiatric emergency ward, those who received occupational therapy.The age (M (SD)) of the participants was 44.25 (8.58) years in the OT + MCT group and 43.25 (7.98) years in the OT alone group.
Participant flow Patients who meet the criteria, n=24.
Random allocation:
OT+MCT group, n=12
OT alone group, n=12
4 members of the OT+MCT group were discharged during the follow-up period.
2 of the OT alone groups were discharged and another two withdrew their consent.
Adverse events None
Outcome measures The Brief Assessment of Cognition in Schizophrenia (BACS)
Positive and Negative Syndrome Scale (PANSS)
Beck Cognitive Insight Scale (BCIS)
Intrinsic Motivation Inventory (IMI)
Client Satisfaction Questionnaire (CSQ)
Plan to share IPD
IPD sharing Plan description

Progress
Recruitment status Completed
Date of protocol fixation
2018 Year 09 Month 04 Day
Date of IRB
2018 Year 09 Month 04 Day
Anticipated trial start date
2018 Year 09 Month 10 Day
Last follow-up date
2020 Year 12 Month 31 Day
Date of closure to data entry
2020 Year 12 Month 31 Day
Date trial data considered complete
2020 Year 12 Month 31 Day
Date analysis concluded
2021 Year 03 Month 31 Day

Other
Other related information

Management information
Registered date
2018 Year 09 Month 12 Day
Last modified on
2021 Year 02 Month 10 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000038868

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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