UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000044956 |
|---|---|
| Receipt number | R000051349 |
| Scientific Title | Efficacy of metacognitive training for long-term hospitalized patients with schizophrenia |
| Date of disclosure of the study information | 2021/07/27 |
| Last modified on | 2021/07/26 13:00:40 |
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Basic information
Public title
Efficacy of metacognitive training for long-term hospitalized patients with schizophrenia
Acronym
Efficacy of metacognitive training for long-term hospitalized patients with schizophrenia
Scientific Title
Efficacy of metacognitive training for long-term hospitalized patients with schizophrenia
Scientific Title:Acronym
Efficacy of metacognitive training for long-term hospitalized patients with schizophrenia
Region
| Japan |
Condition
Condition
schizophrenia
Classification by specialty
| Psychiatry |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To investigate the effectiveness of metacognitive training (MCT) in long-term hospitalized patients with schizophrenia by comparing it with the usual care group.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Japanese version of Montreal Cognitive Assessment (MoCA-J)
Key secondary outcomes
Positive and Negative Syndrome Scale (PANSS)
Beck Cognitive Insight Scale (BCIS-J)
Global Assessment of Functioning (GAF)
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Open -no one is blinded
Control
Active
Stratification
YES
Dynamic allocation
NO
Institution consideration
Institution is not considered as adjustment factor.
Blocking
YES
Concealment
Central registration
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Other |
Interventions/Control_1
MCT will be introduced once a week in addition to regular occupational therapy for a total of 16 sessions.
The target group will receive regular occupational therapy.
Interventions/Control_2
Assign two groups: intervention group and target 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
| 20 | years-old | < |
Age-upper limit
| 80 | years-old | > |
Gender
Male and Female
Key inclusion criteria
1) Patients who have been hospitalized at
Uematsu Hospital for more than one year
(2) Patients with a diagnosis of schizophrenia
(3) Patients undergoing occupational therapy
(4) Patients who have given written consent to participate in this study based on their own free will after receiving sufficient explanation.
Key exclusion criteria
1) Patients under 20 years old.
2) Intellectual disability. Patients with complications such as alcohol or drug dependence, dementia, epilepsy, head trauma, cerebrovascular disease, etc.
3) Patients who have difficulty in performing MCT.
4) Patients who are not receiving occupational therapy.
(5) Patients who cannot give consent to participate in the study
6) Patients who are judged ineligible by the attending physician or principal investigator
Target sample size
60
Research contact person
Name of lead principal investigator
| 1st name | Masayoshi |
| Middle name | |
| Last name | Kobayashi |
Organization
Shinshu University
Division name
Graduate School of General Medical Science and Engineering
Zip code
390-8621
Address
Nagano,Matsumoto,asahi 3-1-1
TEL
0263372403
mkobaya@shinshu-u.ac.jp
Public contact
Name of contact person
| 1st name | Rumi |
| Middle name | |
| Last name | Sunohara |
Organization
NAGANO UNIVERSITY OF HEALTH AND MEDICINE
Division name
Department of Rehabilitation, Faculty of Health Sciences
Zip code
380
Address
Nagano,Nagano.Kawanakajima-machi,Imaihara11-1
TEL
026-283-6111
Homepage URL
sunohara.rumi@shitoku.ac.jp
Sponsor or person
Institute
Shinshu University
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
Ethics Committee ,Shinshu University School of Medicine
Address
Nagano,Matsumoto,Asahi 3-1-1
Tel
0263-37-2572
mdrinri@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
上松病院（長野県）
Other administrative information
Date of disclosure of the study information
| 2021 | Year | 07 | Month | 27 | 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
Preinitiation
Date of protocol fixation
| 2021 | Year | 06 | Month | 10 | Day |
Date of IRB
| 2021 | Year | 06 | Month | 11 | Day |
Anticipated trial start date
| 2021 | Year | 08 | Month | 17 | Day |
Last follow-up date
| 2022 | Year | 08 | 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 | 07 | Month | 26 | Day |
Last modified on
| 2021 | Year | 07 | Month | 26 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000051349
