UMIN-ICDS Clinical Trial
| Unique ID issued by UMIN | UMIN000059887 |
|---|---|
| Receipt number | R000068165 |
| Scientific Title | Verification of the effectiveness of AI-based web-based email consultation |
| Date of disclosure of the study information | 2025/11/30 |
| Last modified on | 2025/11/26 14:55:17 |
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Basic information
Public title
Verification of the effectiveness of AI-based web-based email consultation
Acronym
Verification of the effectiveness of AI-based web-based email consultation
Scientific Title
Verification of the effectiveness of AI-based web-based email consultation
Scientific Title:Acronym
Verification of the effectiveness of AI-based web-based email consultation
Region
| Japan |
Condition
Condition
No applicable
Adult
Classification by specialty
| Not applicable | Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
(1) In a non-randomized parallel-group comparative study, to compare and verify the effectiveness of the "Web-based Email Consultation" service for approximately 50 employees, which is provided by counselors, and the new "Web-based Email Consultation" service for approximately 50 employees, which is based on the drafting of AI.
(2) To examine the effectiveness of the new "WebMail Consultation" by comparing the rating scales of approximately 20 employees of small and medium-sized companies before and after the consultation in a pre- and post-comparison study.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Confirmatory
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Level of willingness to act (within 72 hours after registration for consultation)
Key secondary outcomes
Mental toughness (excerpt), resolution, satisfaction, free comments, IOSDMH scale
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Non-randomized
Randomization unit
Blinding
Single blind -participants are blinded
Control
Active
Stratification
YES
Dynamic allocation
YES
Institution consideration
Institution is not considered as adjustment factor.
Blocking
NO
Concealment
Central registration
Intervention
No. of arms
2
Purpose of intervention
Educational,Counseling,Training
Type of intervention
| Behavior,custom |
Interventions/Control_1
Prior research has reported the effectiveness of AI chatbots in providing emotional support and improving depression symptoms (suggesting the possibility of a new form of consultation utilizing AI). ARM aims to develop a drafting system based on Microsoft's Copilot-based generative AI technology by 2025, and to utilize it in practical situations in stages.
In this study, we will compare and verify the effectiveness of the conventional counselor-assisted "WebMail Consultation" and the "WebMail Consultation" using generative AI.
Intervention 1 will utilize generative AI.
Interventions/Control_2
Response by conventional psychotherapist
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
| 70 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
People who use the service
Key exclusion criteria
Excludes consultations outside the scope of psychological intervention, such as health counseling and financial counseling
Target sample size
120
Research contact person
Name of lead principal investigator
| 1st name | TAKUTO |
| Middle name | |
| Last name | DOI |
Organization
Advantage Risk Management Co., Ltd.
Division name
Research Department
Zip code
153-0051
Address
17F Nakameguro GT tower 2-1-1 Kamimeguro Meguro-ku, Tokyo, Japan
TEL
0357943817
tdoi@armg.jp
Public contact
Name of contact person
| 1st name | TAKUTO |
| Middle name | |
| Last name | DOI |
Organization
ADVANTAGE Risk Management Co., Ltd.
Division name
Research Department
Zip code
153-0051
Address
17F Nakameguro GT tower 2-1-1 Kamimeguro Meguro-ku, Tokyo, Japan
TEL
03-5794-3817
Homepage URL
tdoi@armg.jp
Sponsor or person
Institute
ADVANTAGE Risk Management Co., Ltd.
Institute
Department
Personal name
Funding Source
Organization
ADVANTAGE Risk Management Co., Ltd.
Organization
Division
Category of Funding Organization
Profit organization
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
METI
IRB Contact (For public release)
Organization
ADVANTAGE Risk Management Co., Ltd.
Address
17F Nakameguro GT tower 2-1-1 Kamimeguro Meguro-ku, Tokyo, Japan
Tel
03-5794-3817
snakagawa@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
| 2025 | Year | 11 | Month | 30 | 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 | 10 | Month | 30 | Day |
Date of IRB
Anticipated trial start date
| 2025 | Year | 11 | Month | 13 | Day |
Last follow-up date
| 2025 | Year | 11 | Month | 13 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2025 | Year | 11 | Month | 26 | Day |
Last modified on
| 2025 | Year | 11 | Month | 26 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000068165
