UMIN-ICDS Clinical Trial
| Unique ID issued by UMIN | UMIN000063410 |
|---|---|
| Receipt number | R000072574 |
| Scientific Title | Association of changes in physical activity and occupational balance with return-to-work readiness among patients with depression or adjustment disorder preparing for return to work or employment |
| Date of disclosure of the study information | 2026/10/25 |
| Last modified on | 2026/10/25 15:30:40 |
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Basic information
Public title
Association of physical activity and balance in daily activities with readiness for return to work among people with depression or adjustment disorder preparing for return to work or employment
Acronym
Association of daily activities with readiness for return to work
Scientific Title
Association of changes in physical activity and occupational balance with return-to-work readiness among patients with depression or adjustment disorder preparing for return to work or employment
Scientific Title:Acronym
Association of physical activity and occupational balance with return-to-work readiness
Region
| Japan |
Condition
Condition
Single episode depressive disorder (6A70), recurrent depressive disorder (6A71), adjustment disorder (6B43)
Classification by specialty
| Psychiatry |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To establish methods for supporting daytime activities in patients with depression or adjustment disorder who are preparing to return to work, this study aims to examine longitudinal changes in return-to-work readiness (PRRS) among participants in a return-to-work (RTW) program and to investigate how daytime activity patterns, including the number of daily occupations, occupational balance, physical activity, and sleep duration, are associated with these changes.
Basic objectives2
Others
Basic objectives -Others
To examine the association between longitudinal changes in physical activity and occupational balance and return-to-work readiness among patients with depression or adjustment disorder preparing for return to work or employment.
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
return-to-work readiness
Key secondary outcomes
Base
Study type
Observational
Study design
Basic design
Randomization
Randomization unit
Blinding
Control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
Purpose of intervention
Type of intervention
Interventions/Control_1
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
Eligibility
Age-lower limit
| 20 | years-old | <= |
Age-upper limit
| 65 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
Individuals aged 20 to 65 years who have been diagnosed with depression or adjustment disorder.
Individuals who have been prescribed a program by a physician to support preparation for return to work or employment.
Individuals who wish to return to work or seek re-employment.
Key exclusion criteria
Individuals who do not intend to return to work or seek employment.
Individuals with comorbid dementia, substance abuse, or epilepsy.
Individuals with less than three months of available sick leave and therefore unable to participate sufficiently in the program.
Individuals who are deemed unsuitable for participation in the study by the principal investigator for any other reason.
Target sample size
130
Research contact person
Name of lead principal investigator
| 1st name | Nobuhiro |
| Middle name | |
| Last name | Sugiyama |
Organization
Shinshu University
Division name
School of Health Sciences
Zip code
390-8621
Address
3-1-1 Asahi, Matsumoto, Nagano, Japan
TEL
0263-37-2402
nsugi@shinshu-u.ac.jp
Public contact
Name of contact person
| 1st name | Sachie |
| Middle name | |
| Last name | Tanaka |
Organization
Shinshu University
Division name
School of Health Sciences
Zip code
390-8621
Address
3-1-1 Asahi, Matsumoto, Nagano, Japan
TEL
0263-37-2401
Homepage URL
sachifuk@shinshu-u.ac.jp
Sponsor or person
Institute
Shinshu University
Institute
Department
Personal name
Funding Source
Organization
None
Organization
Division
Category of Funding Organization
Self funding
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Shinshu University School of Medicine Biological and Medical Research Ethics Committee
Address
3-1-1 Asahi, Matsumoto, Nagano, Japan
Tel
0263-37-3099
sachifuk@shinshu-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
Other administrative information
Date of disclosure of the study information
| 2026 | Year | 10 | Month | 25 | 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
Open public recruiting
Date of protocol fixation
| 2026 | Year | 06 | Month | 10 | Day |
Date of IRB
| 2026 | Year | 06 | Month | 17 | Day |
Anticipated trial start date
| 2026 | Year | 08 | Month | 01 | Day |
Last follow-up date
| 2031 | Year | 04 | Month | 30 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
This is a prospective observational study of patients with depression or adjustment disorder participating in a return-to-work or employment preparation program. No intervention or treatment allocation will be conducted for research purposes. Physical activity, occupational balance, and return-to-work readiness will be measured repeatedly during the course of usual clinical care. Measurements will be conducted for seven consecutive days once a month, from the start of the return-to-work program until the date of return to work. Longitudinal changes in these measures and the associations of changes in physical activity and occupational balance with return-to-work readiness will be examined.
Management information
Registered date
| 2026 | Year | 10 | Month | 25 | Day |
Last modified on
| 2026 | Year | 10 | Month | 25 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000072574
