UMIN-ICDS Clinical Trial
| Unique ID issued by UMIN | UMIN000062641 |
|---|---|
| Receipt number | R000071661 |
| Scientific Title | An Exploratory Study of the Effectiveness of Rework Programs by Course Type and Factors Influencing Their Outcomes |
| Date of disclosure of the study information | 2026/08/20 |
| Last modified on | 2026/08/21 20:57:55 |
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Basic information
Public title
An Exploratory Study of the Effectiveness of Rework Programs by Course Type and Factors Influencing Their Outcomes
Acronym
An Exploratory Study of the Effectiveness of Rework Programs by Course Type and Factors Influencing Their Outcomes
Scientific Title
An Exploratory Study of the Effectiveness of Rework Programs by Course Type and Factors Influencing Their Outcomes
Scientific Title:Acronym
An Exploratory Study of the Effectiveness of Rework Programs by Course Type and Factors Influencing Their Outcomes
Region
| Japan |
Condition
Condition
Depression
Classification by specialty
| Psychiatry |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To identify the characteristics of individuals who participated in either a standard 6-month or short-term 1-month return-to-work (rework) program following treatment for major depressive disorder, comparing those who maintained employment with those who did not at 8 and 14 months after completion of the rework program.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Depressive symptoms: Beck Depression Inventory-II (BDI-II)
Social functioning: Japanese version of the Social Adaptation Self-evaluation Scale (SASS-J)
Cognitive function: THINC-it
Employment retention status
Key secondary outcomes
Autism-Spectrum Quotient
Conners Adult ADHD Rating Scales
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is 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
Standard 6-month rework program
Interventions/Control_2
Short-term 1-month rework program
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
Individuals who are on leave from work due to depression or a depressive state
Adults who are employed
Individuals who participate in the rework program at the study site
Individuals who are enrolled in either the short term course of approximately 1 month or the standard course of 6 to 7 months at the start of the rework program
Individuals who are able to understand the study procedures and provide informed consent to participate
Key exclusion criteria
Individuals with bipolar disorder, schizophrenia spectrum disorders, severe substance use disorders, or evident neurocognitive disorders; those expected to have substantial missing data for the primary outcome measures; and those anticipated to be lost to follow-up.
Target sample size
250
Research contact person
Name of lead principal investigator
| 1st name | Yutaro |
| Middle name | |
| Last name | Akaki |
Organization
Fujita Mental Care Satellite Tokushige-Kita Rework Center
Division name
daycare
Zip code
458-0852
Address
1-205 Moto-Tokushige, Midori-ku, Nagoya, Aichi, Japan
TEL
052-879-3310
n-yasu@n-fukushi.ac.jp
Public contact
Name of contact person
| 1st name | Yasuhisa |
| Middle name | |
| Last name | Nakamura |
Organization
Nihon Fukushi University
Division name
School of Health Sciences
Zip code
475-0012
Address
26-2,Higashighaemi-cho
TEL
0569200131
Homepage URL
n-yasu@n-fukushi.ac.jp
Sponsor or person
Institute
Mental Care Satellite Tokushige-Kita Rework Center
Institute
Department
Personal name
Funding Source
Organization
Nihon Fukushi University
Organization
Division
Category of Funding Organization
Other
Nationality of Funding Organization
Japan
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Ethics Review Committee of Seishinkai Medical Corporation
Address
3-879 Minamiyakata, Sakae-cho, Toyoake, Aichi, Japan
Tel
0562-97-1361
n-yasu@n-fukushi.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
Other administrative information
Date of disclosure of the study information
| 2026 | Year | 08 | Month | 20 | 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
Enrolling by invitation
Date of protocol fixation
| 2026 | Year | 07 | Month | 31 | Day |
Date of IRB
| 2026 | Year | 07 | Month | 06 | Day |
Anticipated trial start date
| 2026 | Year | 08 | Month | 21 | Day |
Last follow-up date
| 2030 | 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 | 08 | Month | 20 | Day |
Last modified on
| 2026 | Year | 08 | Month | 21 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000071661
