UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000026146
Receipt number R000030051
Scientific Title Effectiveness of a cognitive remediation program with original computerized cognitive training and group intervention for patients with schizophrenia.
Date of disclosure of the study information 2017/02/15
Last modified on 2019/06/20 10:10:42

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Basic information

Public title

Effectiveness of a cognitive remediation program with original computerized cognitive training and group intervention for patients with schizophrenia.

Acronym

Effectiveness of a cognitive remediation program with original computerized cognitive training and group intervention for patients with schizophrenia.

Scientific Title

Effectiveness of a cognitive remediation program with original computerized cognitive training and group intervention for patients with schizophrenia.

Scientific Title:Acronym

Effectiveness of a cognitive remediation program with original computerized cognitive training and group intervention for patients with schizophrenia.

Region

Japan


Condition

Condition

schizophrenia

Classification by specialty

Psychiatry

Classification by malignancy

Others

Genomic information

NO


Objectives

Narrative objectives1

We aim to examine whether a cognitive remediation program including both computerised cognitive training using Jcores and therapist intervention for transferring gained cognitive improvement into a real-world setting is more effective than treatment as usual.

Basic objectives2

Safety,Efficacy

Basic objectives -Others


Trial characteristics_1

Confirmatory

Trial characteristics_2

Pragmatic

Developmental phase

Not applicable


Assessment

Primary outcomes

the Brief Assessment of Cognition in Schizophrenia

Key secondary outcomes

Positive and Negative Syndrome Scale
Life Assessment Scale for Mentally Ill
NIRS
MRI
serum BDNF, proBDNF, MMP9


Base

Study type

Interventional


Study design

Basic design

Parallel

Randomization

Randomized

Randomization unit

Individual

Blinding

Open -but assessor(s) are blinded

Control

Active

Stratification

YES

Dynamic allocation

YES

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

Behavior,custom

Interventions/Control_1

a cognitive remediation programme with original computerised cognitive training and group meeting

Interventions/Control_2

Participants engaged in two computerised cognitive training sessions and one group meeting per week for 12 weeks.

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

60 years-old >

Gender

Male and Female

Key inclusion criteria

Participants were outpatients diagnosed with Schizophrenia by psychiatrists according to DSM-5 criteria.

Key exclusion criteria

mental retardation
history of drug or alcohol abuse
organic central nervous system disorder

Target sample size

40


Research contact person

Name of lead principal investigator

1st name Yasuhiro
Middle name
Last name Matsuda

Organization

Nara Medical University School of Medicine

Division name

Department of Psychiatry

Zip code

634-8522

Address

840 Shijo-cho, Kashihara, Nara 634-8523, Japan

TEL

0744-22-3051

Email

yasumatsuda319@hotmail.com


Public contact

Name of contact person

1st name Yasuhiro
Middle name
Last name Matsuda

Organization

Nara Medical University School of Medicine

Division name

Department of Psychiatry

Zip code

634-8522

Address

840 Shijo-cho, Kashihara, Nara 634-8523, Japan

TEL

0744-22-3051

Homepage URL


Email

yasumatsuda319@hotmail.com


Sponsor or person

Institute

Nara Medical University School of Medicine

Institute

Department

Personal name



Funding Source

Organization

KAKENHI

Organization

Division

Category of Funding Organization

Non profit foundation

Nationality of Funding Organization

Japan


Other related organizations

Co-sponsor


Name of secondary funder(s)



IRB Contact (For public release)

Organization

Nara Medical University School of Medicine

Address

840 Shijo-cho, Kashihara, Nara 634-8523, Japan

Tel

0744-22-3051

Email

smuraka@naramed-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

奈良県立医科大学附属病院


Other administrative information

Date of disclosure of the study information

2017 Year 02 Month 15 Day


Related information

URL releasing protocol


Publication of results

Published


Result

URL related to results and publications


Number of participants that the trial has enrolled

62

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

Main results already published

Date of protocol fixation

2013 Year 08 Month 19 Day

Date of IRB

2013 Year 08 Month 19 Day

Anticipated trial start date

2013 Year 08 Month 19 Day

Last follow-up date

2020 Year 03 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

2017 Year 02 Month 15 Day

Last modified on

2019 Year 06 Month 20 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000030051


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name