UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000029878 |
|---|---|
| Receipt number | R000034112 |
| Scientific Title | Effects of the vocational program that combined cognitive remediation using the original software "Jcores" and supported employment for job tenure and employment rate with severe mental illness |
| Date of disclosure of the study information | 2017/11/10 |
| Last modified on | 2020/08/04 10:24:54 |
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Basic information
Public title
Effects of the vocational program that combined cognitive remediation using the original software "Jcores" and supported employment for job tenure and employment rate with severe mental illness
Acronym
cognitive remediation and supported employment for SMI
Scientific Title
Effects of the vocational program that combined cognitive remediation using the original software "Jcores" and supported employment for job tenure and employment rate with severe mental illness
Scientific Title:Acronym
cognitive remediation and supported employment for SMI
Region
| Japan |
Condition
Condition
schizophrenia, mood disorder, bipolar disorder and developmental disorder
Classification by specialty
| Psychiatry |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
The purpose of this study is to examine effects of the vocational program that combined cognitive remediation (CR) and supported employment (SE) for job tenure and employment rate with severe mental illness.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Confirmatory
Trial characteristics_2
Developmental phase
Not applicable
Assessment
Primary outcomes
Employment rate and job tenure 12 months after the base line
Key secondary outcomes
Cognitive function 4 months after the base line
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Open -but assessor(s) are blinded
Control
No treatment
Stratification
YES
Dynamic allocation
NO
Institution consideration
Blocking
YES
Concealment
Central registration
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Behavior,custom |
Interventions/Control_1
Supported employment with cognitive remediation using "Jcores"(intervention)
Interventions/Control_2
Supported employment only (control)
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) having motivation for work
2) Not having been able to get the job 6 months from the start of supported employment or returning to agency within three months from the beginning of there work (=being avocational services non-responder)
Key exclusion criteria
1) having a diagnosis of personality disorder or organic disease
Target sample size
80
Research contact person
Name of lead principal investigator
| 1st name | Sayaka |
| Middle name | |
| Last name | Sato |
Organization
National Institute of Mental Health, National Center of Neurology and Psychiatry
Division name
Department of Psychiatric Rehabilitation
Zip code
187-8553
Address
4-1-1 Ogawa Higachimachi Kodaira Tokyo Japan 1878553
TEL
0423462168
sayakas@ncnp.go.jp
Public contact
Name of contact person
| 1st name | Sayaka |
| Middle name | |
| Last name | Sato |
Organization
NCNP
Division name
Department of Psychiatric Rehabilitation
Zip code
187-8553
Address
4-1-1 Ogawa Higachimachi Kodaira Tokyo Japan 1878553
TEL
0423462168
Homepage URL
sayakas@ncnp.go.jp
Sponsor or person
Institute
National Institute of Mental Health, National Center of Neurology and Psychiatry
Institute
Department
Personal name
Funding Source
Organization
Japan Agency for Medical Research and Devepolment
Organization
Division
Category of Funding Organization
Japanese Governmental office
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
National Institute of Mental Health, NCNP
Address
4-1-1, Ogawa-higashi, Kodaira, Tokyo
Tel
0423462168
rinri-jimu@ncnp.go.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 | 11 | Month | 10 | 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
Completed
Date of protocol fixation
| 2017 | Year | 09 | Month | 22 | Day |
Date of IRB
| 2017 | Year | 09 | Month | 22 | Day |
Anticipated trial start date
| 2017 | Year | 10 | Month | 01 | 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 | 11 | Month | 08 | Day |
Last modified on
| 2020 | Year | 08 | Month | 04 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000034112
| Research Plan | |
|---|---|
| Registered date | File name |
| Research case data specifications | |
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| Registered date | File name |
| Research case data | |
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| Registered date | File name |
