UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000055643 |
|---|---|
| Receipt number | R000063593 |
| Scientific Title | Verification of the Utility and Validity of Counseling AI Using Large Language Models |
| Date of disclosure of the study information | 2024/09/27 |
| Last modified on | 2024/09/27 11:44:03 |
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Basic information
Public title
Verification of the Utility and Validity of Counseling AI Using Large Language Models
Acronym
Verification of the Utility and Validity of Counseling AI Using Large Language Models
Scientific Title
Verification of the Utility and Validity of Counseling AI Using Large Language Models
Scientific Title:Acronym
Verification of the Utility and Validity of Counseling AI Using Large Language Models
Region
| Japan |
Condition
Condition
Healthy individuals
Classification by specialty
| Psychiatry |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
This study aims to collect counseling data and verify the effectiveness and validity of counselor utterance generation by counseling AI using Large Language Models (LLMs) as a foundational research step in the development of counseling AI.
Basic objectives2
Others
Basic objectives -Others
NA
Trial characteristics_1
Exploratory
Trial characteristics_2
Others
Developmental phase
Not applicable
Assessment
Primary outcomes
Effectiveness of Utterances Generated by Counseling AI: Assessing whether the AI is effective in functioning as a counselor.
Validity of Utterances Generated by Counseling AI: Determining if the AI can generate expected responses and maintain coherent conversations.
Comparison Between AI-Generated and Human-Generated Utterances: Evaluating whether the AI generates responses similar to those of highly-rated human counselors.
Key secondary outcomes
Relationship with User Characteristics and Preferences: Examining whether user characteristics and preferences (such as gender, age, and counseling needs) are related to the evaluation of AI-generated utterances.
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 at the time of obtaining consent.
Individuals capable of providing informed consent after understanding the details of this study.
Individuals with access to an internet environment that allows online counseling (use of free WiFi is not permitted) and who own both a computer and a smartphone.
Individuals engaged in psychological counseling; those who are certified public psychologists or licensed clinical psychologists are preferred. University students or graduate students undergoing training in counseling programs are also eligible.
Individuals not undergoing treatment for any mental disorder at the time of participation in the study.
Key exclusion criteria
Individuals with intellectual disabilities, dementia, or any language or thought disorders that may hinder communication during consent acquisition or counseling.
Individuals whose native language is not Japanese.
Any other individuals deemed ineligible for participation by the researchers.
Individuals currently receiving counseling or psychiatric treatment at the time of study participation.
Target sample size
50
Research contact person
Name of lead principal investigator
| 1st name | Yoshiharu |
| Middle name | |
| Last name | Kim |
Organization
National Center of Neurology and Psychiatry
Division name
National Institute of Mental Health
Zip code
187-8553
Address
4-1-1, Ogawahigashi, Kodaira, Tokyo
TEL
042-341-2711
joice21@yc4.so-net.ne.jp
Public contact
Name of contact person
| 1st name | Zui |
| Middle name | C |
| Last name | Narita |
Organization
National Center of Neurology and Psychiatry
Division name
National Institute of Mental Health
Zip code
187-8553
Address
4-1-1, Ogawahigashi, Kodaira, Tokyo
TEL
042-341-2711
Homepage URL
zuinarita@ncnp.go.jp
Sponsor or person
Institute
National Center of Neurology and Psychiatry
Institute
Department
Personal name
Funding Source
Organization
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
National Center of Neurology and Psychiatry Institutional Review Board
Address
4-1-1, Ogawahigashi, Kodaira, Tokyo
Tel
042-341-2711
rinri-jimu@ncnp.go.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
| 2024 | Year | 09 | Month | 27 | 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
| 2023 | Year | 11 | Month | 28 | Day |
Date of IRB
| 2024 | Year | 01 | Month | 17 | Day |
Anticipated trial start date
| 2024 | Year | 01 | Month | 17 | Day |
Last follow-up date
| 2026 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
NA
Management information
Registered date
| 2024 | Year | 09 | Month | 27 | Day |
Last modified on
| 2024 | Year | 09 | Month | 27 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000063593
