UMIN-ICDS Clinical Trial
| Unique ID issued by UMIN | UMIN000061917 |
|---|---|
| Receipt number | R000070850 |
| Scientific Title | Effect research of toughness-Counseling3 |
| Date of disclosure of the study information | 2026/06/20 |
| Last modified on | 2026/06/15 17:25:58 |
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Basic information
Public title
Effect research of toughness-Counseling3
Acronym
Effect research of toughness-Counseling3
Scientific Title
Effect research of toughness-Counseling3
Scientific Title:Acronym
Effect research of toughness-Counseling3
Region
| Japan |
Condition
Condition
healthy
mental disorder
Classification by specialty
| Psychosomatic Internal Medicine |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
Examine what kind of effect toughness-counseling will have on the target audience
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Exploratory
Trial characteristics_2
Explanatory
Developmental phase
Assessment
Primary outcomes
cognitive transformation
behavioral change
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
Single arm
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Self control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
1
Purpose of intervention
Educational,Counseling,Training
Type of intervention
| Behavior,custom |
Interventions/Control_1
cognitive behavioral therapy
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
| Not applicable |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
Employees belongs to Contract companies
Key exclusion criteria
not applicable
Target sample size
50
Research contact person
Name of lead principal investigator
| 1st name | YUMIKA |
| Middle name | |
| Last name | NISHIMURA |
Organization
ADVANTAGE Risk Management Co., Ltd.
Division name
Advantage Counselling Center
Zip code
161-0032
Address
16F Nakameguro GT Tower, Kamimeguro 2-1-1, Meguro-ku Tokyo
TEL
0357736145
ynishimura2@armg.jp
Public contact
Name of contact person
| 1st name | Yumika |
| Middle name | |
| Last name | Nishimura |
Organization
ADVANTAGE Risk Management Co., Ltd.
Division name
Advantage Counselling Center
Zip code
161-0032
Address
16F Nakameguro GT Tower, Kamimeguro 2-1-1, Meguro-ku Tokyo
TEL
0357736145
Homepage URL
ynishimura2@armg.jp
Sponsor or person
Institute
ADVANTAGE Risk Management Co., Ltd.
Advantage Counselling Center
Institute
Department
Personal name
Funding Source
Organization
ADVANTAGE Risk Management Co., Ltd.
Advantage Counselling Center
Organization
Division
Category of Funding Organization
Profit organization
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
ADVANTAGE Risk Management Co., Ltd.
Address
16F Nakameguro GT Tower, Kamimeguro 2-1-1, Meguro-ku Tokyo
Tel
0357736145
ynishimura2@armg.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 | 06 | 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
Preinitiation
Date of protocol fixation
| 2025 | Year | 06 | Month | 30 | Day |
Date of IRB
| 2026 | Year | 10 | Month | 01 | Day |
Anticipated trial start date
| 2026 | Year | 06 | Month | 20 | Day |
Last follow-up date
| 2026 | Year | 11 | Month | 01 | 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 | 06 | Month | 15 | Day |
Last modified on
| 2026 | Year | 06 | Month | 15 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000070850
