UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000034106 |
|---|---|
| Receipt number | 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 13:26:04 |
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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
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
mkobaya@shinshu-u.ac.jp
Sponsor or person
Institute
Tikumaso Mental Hospital
Institute
Department
Personal name
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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000038868
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