UMIN-ICDS Clinical Trial
| Unique ID issued by UMIN | UMIN000060837 |
|---|---|
| Receipt number | R000069610 |
| Scientific Title | Effectiveness of Cognitive Rehabilitation in an Employment Support Program for People with Mental Disorders: A Randomized Controlled Trial |
| Date of disclosure of the study information | 2026/03/05 |
| Last modified on | 2026/03/05 17:29:04 |
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Basic information
Public title
Effectiveness of Cognitive Rehabilitation in an Employment Support Program for People with Mental Disorders: A Randomized Controlled Trial
Acronym
Effectiveness of Cognitive Rehabilitation in an Employment Support Program for People with Mental Disorders
Scientific Title
Effectiveness of Cognitive Rehabilitation in an Employment Support Program for People with Mental Disorders: A Randomized Controlled Trial
Scientific Title:Acronym
Effectiveness of Cognitive Rehabilitation in an Employment Support Program for People with Mental Disorders
Region
| Japan |
Condition
Condition
mental illness
Classification by specialty
| Psychiatry | Rehabilitation medicine |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
The purpose of this study is to evaluate the effectiveness of adding cognitive rehabilitation using RehaCom to an employment support program based on supported employment for people with mental disorders.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
BACS z-score (change from baseline to post-intervention)
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Open -but assessor(s) are blinded
Control
Active
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Behavior,custom |
Interventions/Control_1
In the intervention group, cognitive rehabilitation using RehaCom will be added to the employment support program based on Individual Placement and Support (IPSBP). Cognitive rehabilitation will be provided twice weekly for 12 weeks, for a total of 24 sessions, with each session lasting up to 60 minutes.
Interventions/Control_2
In the control group, the employment support program based on Individual Placement and Support (IPSBP) will be provided. To equalize the total program time between the two groups, participants in the control group will engage in computer practice during the time corresponding to the cognitive rehabilitation sessions in the intervention group.
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
| 18 | years-old | <= |
Age-upper limit
| 64 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
-Diagnosed with a mental disorder according to DSM-5
-Aged 18 to 64 years
-Registered as a user of the psychiatric day care service at Chikuma-so Hospital
-Willing to work
-Agreed to use the disability employment system and participate in the employment support program
-Provided written informed consent
Key exclusion criteria
-Younger than 18 years or older than 64 years
-Comorbid intellectual disability, dementia, epilepsy, head injury, or cerebrovascular disease
-Unstable condition making participation in the employment support program or cognitive assessments difficult
-Did not provide informed consent
-Judged ineligible by the attending physician or principal investigator
Target sample size
38
Research contact person
Name of lead principal investigator
| 1st name | Kojiro |
| Middle name | |
| Last name | Kawano |
Organization
Saitama Prefectural University
Division name
Department of Occupational therapy
Zip code
3438540
Address
820 Sannomiya, Koshigaya-shi, Saitama, Japan
TEL
048-971-0500
kawano-kojiro@umin.ac.jp
Public contact
Name of contact person
| 1st name | Kojiro |
| Middle name | |
| Last name | Kawano |
Organization
Saitama Prefectural University
Division name
Department of Occupational therapy
Zip code
3438540
Address
820 Sannomiya, Koshigaya-shi, Saitama, Japan
TEL
048-971-0500
Homepage URL
kawano-kojiro@umin.ac.jp
Sponsor or person
Institute
Saitama Prefectural University
Institute
Department
Personal name
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)
IRB Contact (For public release)
Organization
Saitama Prefectural University Research Ethics Committee
Address
820 Sannomiya, Koshigaya-shi, Saitama, Japan
Tel
048-971-0500
kawano-kojiro@umin.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
医療法人友愛会千曲荘病院（長野県）
Other administrative information
Date of disclosure of the study information
| 2026 | Year | 03 | Month | 05 | 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
Preinitiation
Date of protocol fixation
| 2026 | Year | 03 | Month | 05 | Day |
Date of IRB
Anticipated trial start date
| 2026 | Year | 03 | Month | 31 | Day |
Last follow-up date
| 2028 | 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
| 2026 | Year | 03 | Month | 05 | Day |
Last modified on
| 2026 | Year | 03 | Month | 05 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000069610
