UMIN-CTR Clinical Trial

BACK TOP
UMIN-CTR English Home Glossary (Simple) FAQ Search clinical trials

Name:
UMIN ID:

Recruitment status No longer recruiting
Unique ID issued by UMIN UMIN000024546
Receipt No. 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 2018/04/26

* This page includes information on clinical trials registered in UMIN clinical trial registed system.
* We don't aim to advertise certain products or treatments


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
Middle name
Last name Kobayashi Masayoshi
Organization Shinshu University Graduate School of Medicine
Division name Health Science
Zip code
Address 3-1-1, Asahi, Matsumoto, Nagano Prefecture
TEL 0263-37-2403
Email mkobaya@shinshu-u.ac.jp

Public contact
Name of contact person
1st name
Middle name
Last name Kobayashi Masayoshi
Organization Shinshu University Graduate School of Medicine
Division name Health Science
Zip code
Address 3-1-1, Asahi, Matsumoto, Nagano Prefecture
TEL 0263-37-2403
Homepage URL
Email mkobaya@shinshu-u.ac.jp

Sponsor
Institute Murai mental hospital
Institute
Department

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
Address
Tel
Email

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
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 No longer recruiting
Date of protocol fixation
2016 Year 09 Month 06 Day
Date of IRB
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
2018 Year 04 Month 26 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000028246

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


Contact us.