UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000024546 |
|---|---|
| Receipt number | R000028246 |
| Scientific Title | Cross-over study on the effectiveness of meta-cognitive training for schizophrenic patients |
| Date of disclosure of the study information | 2017/12/30 |
| Last modified on | 2021/04/28 10:44:36 |
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Basic information
Public title
Cross-over study on the effectiveness of meta-cognitive training for schizophrenic patients
Acronym
Effectiveness of meta-cognitive training for schizophrenic patients
Scientific Title
Cross-over study on the effectiveness of meta-cognitive training for schizophrenic patients
Scientific Title:Acronym
Effectiveness of meta-cognitive training for schizophrenic patients
Region
| Japan |
Condition
Condition
Schizophrenia
Classification by specialty
| Psychiatry | Rehabilitation medicine |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
Cross-over study on the effectiveness of meta-cognitive training for schizophrenic patients
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Change of score of Brief Assessment of Cognition in Schizophrenia (BACS) after 4 months intervention
Key secondary outcomes
Positive and Negative Syndrome Scale (PANSS)
Base
Study type
Interventional
Study design
Basic design
Cross-over
Randomization
Randomized
Randomization unit
Individual
Blinding
Open -no one is blinded
Control
Active
Stratification
YES
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
2
Purpose of intervention
Educational,Counseling,Training
Type of intervention
| Behavior,custom | Maneuver |
Interventions/Control_1
metacognitive training (MCT)
Interventions/Control_2
Regular Program of occupational therapy
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) A person who has been diagnosed with schizophrenia or schizoaffective disorder by the DSM-IV-TR.
2) Those who are hospitalized more than a month in a psychiatric hospital.
3) Patients who have implemented occupational therapy.
4)Those who have agreed to participate in the study.
Key exclusion criteria
1) patients less than or more than 65-year-old 20-year-old.
2) Patients to merge intellectual disorder, alcohol-drug dependence (substance abuse-dependent), dementia, epilepsy, head trauma, cerebral vascular disease, etc.
3) Patients less than 1 month after admission.
4) Patients MCT-J and cognitive function tests can not be carried out because of an unstable medical condition.
5) Patients who do not have implemented the Occupational Therapy.
6) Those who do not agree to participate in the study.
7) Patients who have been determined to be unsuitable for study by the physician and principal investigator.
Target sample size
40
Research contact person
Name of lead principal investigator
| 1st name | Masayoshi |
| Middle name | |
| Last name | Kobayashi |
Organization
Shinshu University Graduate School of Medicine
Division name
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 Medicine
Division name
Health Science
Zip code
390-8621
Address
Matsumoto
TEL
0263372403
Homepage URL
mkobaya@shinshu-u.ac.jp
Sponsor or person
Institute
Shinshu University Graduate School of Medicine
Institute
Department
Personal name
Funding Source
Organization
None
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
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
| 2017 | Year | 12 | Month | 30 | Day |
Related information
URL releasing protocol
https://www.jstage.jst.go.jp/article/asiajot/17/1/17_45/_article/-char/en
Publication of results
Published
Result
URL related to results and publications
https://www.jstage.jst.go.jp/article/asiajot/17/1/17_45/_article/-char/en
Number of participants that the trial has enrolled
22
Results
No significant differences were seen in inter-group comparisons of the scores of various scales at the baseline. Four months and eight months later, a comparison between before and after MCT showed improvement tendencies for both groups in the participants' cognitive function and psychiatric symptoms. A comparison of scores before and after the MCT intervention period, from all participants, showed significant improvement tendencies in their verbal memory and attention.
Results date posted
| 2021 | Year | 04 | Month | 28 | Day |
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
Participating in this study were patients who were diagnosed with schizophrenia by a psychiatrist, based on the diagnostic criteria of the Diagnostic and Statistical Manual of Mental Disorders 5th edition (DSM-5), were admitted to a psychiatric hospital's long-term care ward, and were undergoing occupational therapy. As part of the enrollment criteria for participation, individuals had to be between the ages of 20 and 65 years. The following individuals were excluded: those with intellectual disability and a history of substance abuse and/or dependence, dementia, epilepsy, head injury, and cerebrovascular diseases. Those with unstable disease condition and those whom either a psychiatrist or an occupational therapist had determined as unfit for the study were also excluded.
Participant flow
Of the 43 patients hospitalized inside the long-term care ward, 22 took part in this study. Eleven individuals were randomly allocated to Groups A and B. During the follow-up period, one individual in Group A was discharged from the hospital, and another individual withdrew their consent, while two individuals in Group B were discharged, and another individual withdrew their consent. In the end, nine individuals in Group A (male-to-female ratio = 6:3), and eight in Group B (male-to-female = 4:4) were analyzed.
Adverse events
None
Outcome measures
Four measures were used: the Brief Assessment of Cognition in Schizophrenia (BACS), the Positive and Negative Syndrome Scale (PANSS), the Global Assessment of Functioning (GAF), and the Beck Cognitive Insight Scale (BCIS).
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
Completed
Date of protocol fixation
| 2016 | Year | 09 | Month | 06 | Day |
Date of IRB
| 2016 | Year | 09 | Month | 06 | Day |
Anticipated trial start date
| 2016 | Year | 11 | Month | 01 | Day |
Last follow-up date
| 2020 | Year | 03 | Month | 30 | Day |
Date of closure to data entry
| 2020 | Year | 03 | Month | 30 | Day |
Date trial data considered complete
| 2020 | Year | 03 | Month | 30 | Day |
Date analysis concluded
| 2020 | Year | 03 | Month | 30 | Day |
Other
Other related information
Management information
Registered date
| 2016 | Year | 10 | Month | 24 | Day |
Last modified on
| 2021 | Year | 04 | Month | 28 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000028246
| Research Plan | |
|---|---|
| Registered date | File name |
| 2021/04/28 | 研究計画書.pdf |
| Research case data specifications | |
|---|---|
| Registered date | File name |
| 2021/04/28 | 症例報告書（小林･藤井）.xlsx |
| Research case data | |
|---|---|
| Registered date | File name |
| 2021/04/28 | 症例報告書.xlsx |
