UMIN-ICDS Clinical Trial
| Unique ID issued by UMIN | UMIN000062370 |
|---|---|
| Receipt number | R000071381 |
| Scientific Title | Comparing AI-Based and Human Mental Health Consultation in University Students: A Randomized Controlled Trial Examining Causal Effects on Self-Disclosure Barriers and Help-Seeking Intention |
| Date of disclosure of the study information | 2026/07/28 |
| Last modified on | 2026/07/28 16:37:41 |
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Basic information
Public title
A Randomized Controlled Trial on the Effects of AI Chat and Human Chat-Based Mental Health Consultation on Self-Disclosure Barriers and Subsequent Help-Seeking Intention: A Study Targeting University Students
Acronym
AI vs. Human Chat Consultation RCT: Self-Disclosure Barriers and Help-Seeking Intention in University Students
Scientific Title
Comparing AI-Based and Human Mental Health Consultation in University Students: A Randomized Controlled Trial Examining Causal Effects on Self-Disclosure Barriers and Help-Seeking Intention
Scientific Title:Acronym
AI vs. Human Consultation RCT: Self-Disclosure Barriers and Help-Seeking Intention
Region
| Japan |
Condition
Condition
Healthy
Classification by specialty
| Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
In response to mental health challenges faced by college students, this study compares AI counseling and human counseling as counseling channels and examines (1) the psychological mechanisms underlying barriers to self-disclosure (attitudes toward disclosure inhibition), as well as (2) their impact on the intention to seek counseling and the subjective sense of resolution immediately following the conversation.
Basic objectives2
Others
Basic objectives -Others
influence
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Of the 41 items across 5 factors in the Attitudes Toward Suppressing Stress Disclosure to Close Others Scale, we use 27 items across 3 factors.
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Open -no one is blinded
Control
Active
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
2
Purpose of intervention
Prevention
Type of intervention
| Behavior,custom |
Interventions/Control_1
AI Chat Group:Consult with an AI chatbot based on the provided scenario
Interventions/Control_2
Human Chat Group:Chat with a friend role-player to discuss matters based on the given scenario
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
| Not applicable |
Gender
Male and Female
Key inclusion criteria
1) Undergraduate and graduate students currently enrolled in the Faculty of Health Sciences or the Graduate School of Health Sciences at Fukushima Medical University
2) Individuals who have access to the internet and can use chat tools
3) Individuals who can read and write in Japanese
Key exclusion criteria
1) Individuals currently receiving care or undergoing treatment at a psychiatric or psychosomatic medicine clinic
2) Individuals whom the principal investigator determines would be adversely affected physically or mentally by participating in the study
3) Any other individuals whom the principal investigator determines are unsuitable for participation
Target sample size
30
Research contact person
Name of lead principal investigator
| 1st name | Yohko |
| Middle name | |
| Last name | Ishikawa |
Organization
Fukushima Medical University of Medical Science
Division name
Department of Occupational Therapy, School of Science
Zip code
9608516
Address
10-6 Sakae-machi, Fukushima City, Fukushima Prefecture
TEL
024-581-5550
y-ishi@fmu.ac.jp
Public contact
Name of contact person
| 1st name | Yohko |
| Middle name | |
| Last name | Ishikawa |
Organization
Fukushima Medical University
Division name
Department of Occupational Therapy, School of Science
Zip code
960-8516
Address
10-6 Sakae-machi, Fukushima City, Fukushima Prefecture
TEL
024-581-5550
Homepage URL
y-ishi@fmu.ac.jp
Sponsor or person
Institute
Fukushima Medical University
Institute
Department
Personal name
Funding Source
Organization
Fukushima Medical University
Organization
Division
Category of Funding Organization
Other
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Fukushima Medical University Ethics Review Committee
Address
Hikarigaoka 1, Fukushima City, Fukushima Prefecture
Tel
0245471825
fmurec@fmu.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 | 07 | Month | 28 | 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
| 2026 | Year | 07 | Month | 24 | Day |
Date of IRB
| 2026 | Year | 07 | Month | 24 | Day |
Anticipated trial start date
| 2026 | Year | 07 | Month | 24 | Day |
Last follow-up date
| 2027 | 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 | 07 | Month | 28 | Day |
Last modified on
| 2026 | Year | 07 | Month | 28 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000071381
