UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	Efficacy Assessment of Originally Devised Enjoyable Program of Cognitive Remediation Using Music for Groups of Individuals with Schizophrenia
Title of the study (Brief title)	Cognitive Remediation Using Music for Schizophrenia
Region	Japan

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

Objectives
Narrative objectives1	A new cognitive remediation program is developed through the use of music in order to improve both cognitive disorders and negative symptoms for individuals with schizophrenia. The efficacy of the program will be assessed.
Basic objectives2	Efficacy
Basic objectives -Others
Trial characteristics_1	Exploratory
Trial characteristics_2	Pragmatic
Developmental phase	Not applicable

Assessment
Primary outcomes	1) The Brief Assessment of Cognition in Schizophrenia Japanese Version 2) Brief Psychiatric Rating Scale (Japanese version)
Key secondary outcomes	Brain Function Measurement based on Near Infrared Spectroscopy

In outcomes field, the entry of just a few words such as "safety" or "efficiency" will not be accepted. Specify the name of outcome measures, including the time when you plan to measure. Usually, only one primary outcome is accepted. Write the other outcomes in "secondary outcomes" field.

Base
Study type	Interventional

Study design
Basic design	Single arm
Randomization	Non-randomized
Randomization unit
Blinding	Open -no one is blinded
Control	Uncontrolled
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms	1
Purpose of intervention	Treatment
Type of intervention	Behavior,custom
Interventions/Control_1	Target individuals are required to participate in 60-minutes sessions in the program. There are two sessions in a week, with 30 sessions in total during 15 weeks of intervention period (approximately 4 months). Each 60-minutes session has two sections: a 45-minutes cognitive intervention section and a 15-minutes bridging section. The bridging section means bridging between the intervention and the real-world. The cognitive intervention section employs music, singing songs and playing instruments. In the bridging section, participants are encouraged to talk and discuss how cognitive skills they learn in the section of the same day will help their everyday lives.
Interventions/Control_2
Interventions/Control_3
Interventions/Control_4
Interventions/Control_5
Interventions/Control_6
Interventions/Control_7
Interventions/Control_8
Interventions/Control_9
Interventions/Control_10

In interventions field, include the details of interventions, such as duration, amount, and frequency. If the intervention includes prescription or use of medical devices, duration is required.

Eligibility
Age-lower limit	18 years-old <=
Age-upper limit	60 years-old >=
Gender	Male and Female
Key inclusion criteria	an individual (1) who receives a diagnosis of schizophrenia (2) who goes to a workplace or a day care program (3) who belonged to a regular class in school days and has a higher level of academic ability than junior high school graduate (4) who is able to join programs twice a week in four months (5) who agrees joining this research (6) who allows videotaping while joining the program (The video data is used only for the research purpose. Video data where his/her face appears will not be published without agreement of themselves.) (7) who has normal eyesight and hearing (8) who is able to join a group activity (9) who comes to the workplace more than three months (10) who moves both hands or a single hand freely (11) who allows interviews including medical management
Key exclusion criteria	an individual who does not want touching to music in various reasons
Target sample size	50

Research contact person
Name of lead principal investigator	Naoko Kosugi
Organization	Takasaki University of Health and Welfare
Division name	Faculty of Health and Welfare, Department of Healthcare Informatics
Address	37-1, Nakaorui-machi, Takasaki-shi, Gunma
TEL	027-352-1290
Email	kosugi@takasaki-u.ac.jp

Public contact
Name of contact person	Naoko Kosugi
Organization	Takasaki University of Health and Welfare
Division name	Faculty of Health and Welfare, Department of Healthcare Informatics
Address	37-1, Nakaorui-machi, Takasaki-shi, Gunma
TEL	027-352-1290
Homepage URL
Email	kosugi@takasaki-u.ac.jp

Sponsor
Institute	Takasaki University of Health and Welfare
Institute
Department

Sponsor means an organization that is responsible for plan, deployment and report of the research including funding management. It doesn't mean funding agency". Therefore, all clinical trial should have the one.

Funding Source
Organization	Ministry of Education, Culture, Sports, Science and Technology
Organization
Division
Category of Funding Organization	Japanese Governmental office
Nationality of Funding Organization

Other related organizations
Co-sponsor
Name of secondary funｄer(s)

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	2016 Year 06 Month 20 Day

Progress
Recruitment status	Recruiting
Date of protocol fixation	2016 Year 01 Month 30 Day
Anticipated trial start date	2016 Year 06 Month 20 Day
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Related information
URL releasing protocol
Publication of results	Unpublished
URL releasing results
Results
Other related information

Management information
Registered date	2016 Year 06 Month 12 Day
Last modified on	2016 Year 06 Month 12 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000026080