UMIN-ICDS Clinical Trial
| Unique ID issued by UMIN | UMIN000062930 |
|---|---|
| Receipt number | R000071997 |
| Scientific Title | A Preliminary Study of the Effectiveness of Interpersonal Counseling for Generative AI Dependence Tendencies Among University Students |
| Date of disclosure of the study information | 2026/09/16 |
| Last modified on | 2026/09/15 14:06:36 |
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Basic information
Public title
A Preliminary Study of the Effectiveness of Interpersonal Counseling for Generative AI Dependence Tendencies Among University Students
Acronym
A Preliminary Study of the Effectiveness of Interpersonal Counseling for Generative AI Dependence Tendencies Among University Students
Scientific Title
A Preliminary Study of the Effectiveness of Interpersonal Counseling for Generative AI Dependence Tendencies Among University Students
Scientific Title:Acronym
A Preliminary Study of the Effectiveness of Interpersonal Counseling for Generative AI Dependence Tendencies Among University Students
Region
| Japan |
Condition
Condition
generative AI dependence tendencies
Classification by specialty
| Psychiatry |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
In recent years, opportunities for university students to use generative AI have rapidly increased, while concerns regarding its dependent use have emerged as a significant social issue. However, clinical psychological interventions for university students exhibiting generative AI dependence tendencies have not yet been empirically examined. The primary objective of this study will be to preliminarily examine whether interpersonal counseling (IPC) is effective in reducing generative AI dependence tendencies among university students in a quasi-randomized controlled trial.
Basic objectives2
Others
Basic objectives -Others
This study will examine the association between improvements in generative AI dependence tendencies following IPC and the acquisition of adaptive coping strategies to explore the mechanisms through which IPC may reduce generative AI dependence tendencies. This study will also conduct preliminary analyses, including analyses examining the effects of IPC on generative AI dependence tendencies among university students with ADHD or ASD traits.
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
The primary outcome is the difference between the IPC and active listening groups in changes in the Generative AI Addiction Tendency Scale for High-School and University Students score from pre-intervention to each assessment time point up to 4 weeks after the intervention.
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Single blind -participants are blinded
Control
Active
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Other |
Interventions/Control_1
Interpersonal counseling (once a week, a total of 3 times)
Interventions/Control_2
Counseling with listening (once a week, a total of 3 times)
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
| 29 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
1.Individuals who understand the purpose of the study and provide written informed consent to participate
2.Individuals who are currently enrolled at a university
3.Individuals aged 18-29 years at the time of study participation
4.Individuals exhibiting generative AI dependence tendencies
Key exclusion criteria
1.Individuals at high risk of suicide
2.Individuals who are currently receiving treatment for any condition at a medical institution and are unable to obtain approval for study participation from their attending physician
Target sample size
20
Research contact person
Name of lead principal investigator
| 1st name | Hisae |
| Middle name | |
| Last name | Ono |
Organization
Kwansei Gakuin University
Division name
Department of Integrated Psychological Sciences, School of Humanities
Zip code
662-8501
Address
1-155 Uegahara Ichibancho, Nishinomiya, Hyogo
TEL
0798-54-4517
hisaono@kwansei.ac.jp
Public contact
Name of contact person
| 1st name | Hisae |
| Middle name | |
| Last name | Ono |
Organization
Kwansei Gakuin University
Division name
Department of Integrated Psychological Sciences, School of Humanities
Zip code
662-8501
Address
1-155 Uegahara Ichibancho, Nishinomiya, Hyogo
TEL
0798-54-4517
Homepage URL
hisaono@kwansei.ac.jp
Sponsor or person
Institute
Kwansei Gakuin University
Institute
Department
Personal name
Funding Source
Organization
Mental Health Okamoto Memorial Foundation
Organization
Division
Category of Funding Organization
Non profit foundation
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Kwansei Gakuin University Institutional Review Board for Medical and Biological Research Involving Human Subiects(KGIRB)
Address
1 Ban Gakuen Uegahara, Sanda-shi, Hyogo
Tel
079-565-9052
med-ethic@kwansei.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 | 09 | Month | 16 | 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 | 09 | Month | 10 | Day |
Date of IRB
| 2026 | Year | 09 | Month | 10 | Day |
Anticipated trial start date
| 2026 | Year | 10 | Month | 01 | Day |
Last follow-up date
| 2028 | 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 | 09 | Month | 15 | Day |
Last modified on
| 2026 | Year | 09 | Month | 15 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000071997
