UMIN-CTR Clinical Trial

Public title

Efficacy Assessment of Originally Devised Enjoyable Program of Cognitive Remediation Using Music for Groups of Individuals with Schizophrenia

Acronym

Cognitive Remediation Using Music for Schizophrenia

Scientific Title

Efficacy Assessment of Originally Devised Enjoyable Program of Cognitive Remediation Using Music for Groups of Individuals with Schizophrenia

Scientific Title:Acronym

Cognitive Remediation Using Music for Schizophrenia

Region

Japan

Condition

schizophrenia

Classification by specialty

Psychiatry

Classification by malignancy

Others

Genomic information

NO

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

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

Study type

Interventional

Basic design

Single arm

Randomization

Non-randomized

Randomization unit

Blinding

Open -no one is blinded

Control

Uncontrolled

Stratification

Dynamic allocation

Institution consideration

Blocking

Concealment

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

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

Name of lead principal investigator

1st name
Middle name
Last name	Naoko Kosugi

Organization

Takasaki University of Health and Welfare

Division name

Faculty of Health and Welfare, Department of Healthcare Informatics

Zip code

Address

37-1, Nakaorui-machi, Takasaki-shi, Gunma

TEL

027-352-1290

Email

kosugi@takasaki-u.ac.jp

Name of contact person

1st name
Middle name
Last name	Naoko Kosugi

Organization

Takasaki University of Health and Welfare

Division name

Faculty of Health and Welfare, Department of Healthcare Informatics

Zip code

Address

37-1, Nakaorui-machi, Takasaki-shi, Gunma

TEL

027-352-1290

Homepage URL

Email

kosugi@takasaki-u.ac.jp

Institute

Takasaki University of Health and Welfare

Institute

Department

Personal name

Organization

Ministry of Education, Culture, Sports, Science and Technology

Organization

Division

Category of Funding Organization

Japanese Governmental office

Nationality of Funding Organization

Co-sponsor

Name of secondary funder(s)

Organization

Address

Tel

Email

Secondary IDs

NO

Study ID_1

Org. issuing International ID_1

Study ID_2

Org. issuing International ID_2

IND to MHLW

Institutions

Date of disclosure of the study information

2016

Year

06

Month

20

Day

URL releasing protocol

Publication of results

Unpublished

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

Recruitment status

Date of protocol fixation

2016

Year

01

Month

30

Day

Date of IRB

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

Other related information

Registered date

2016

Year

06

Month

12

Day

Last modified on

2016

Year

06

Month

12

Day

Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000026080