UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000058424 |
|---|---|
| Receipt number | R000065215 |
| Scientific Title | A Pilot Study on the Impact of an AI-Driven Mental Health App on Mental Health and Mental Health Literacy Among University Students |
| Date of disclosure of the study information | 2025/07/10 |
| Last modified on | 2025/07/10 16:23:04 |
* This page includes information on clinical trials registered in UMIN clinical trial registed system.
* We don't aim to advertise certain products or treatments
Basic information
Public title
A Pilot Study on the Impact of an AI-Driven Mental Health App on Mental Health and Mental Health Literacy Among University Students
Acronym
A Pilot Study on the Impact of an AI-Driven Mental Health App on Mental Health and Mental Health Literacy Among University Students
Scientific Title
A Pilot Study on the Impact of an AI-Driven Mental Health App on Mental Health and Mental Health Literacy Among University Students
Scientific Title:Acronym
A Pilot Study on the Impact of an AI-Driven Mental Health App on Mental Health and Mental Health Literacy Among University Students
Region
| Japan |
Condition
Condition
Healthy adult
Classification by specialty
| Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To examine the effectiveness of the AI-powered mental health app on university students' mental health.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Japanese Perceived Stress Scale(baseline, 4 weeks after the start of app use and 2 weeks after the end of app use)
Key secondary outcomes
Japanese version of the Patient Health Questionnaire-9(baseline, 4 weeks after the start of app use and 2 weeks after the end of app use)
Japanese version of the Generalized Anxiety Disorder-7(baseline, 4 weeks after the start of app use and 2 weeks after the end of app use)
Japanese version of the Sence of Coherence scale-13(baseline, 4 weeks after the start of app use and 2 weeks after the end of app use)
Self-Efficacy Scale(baseline, 4 weeks after the start of app use and 2 weeks after the end of app use)
Japanese version of the Athens Insomnia Scale(baseline, 4 weeks after the start of app use and 2 weeks after the end of app use)
Base
Study type
Interventional
Study design
Basic design
Single arm
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Uncontrolled
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
1
Purpose of intervention
Educational,Counseling,Training
Type of intervention
| Other |
Interventions/Control_1
In this study, the intervention involves the use of the AI-powered mental health app Awarefy. Awarefy records and analyzes users' emotions and stress levels, providing personalized mental health support. The app incorporates features based on cognitive behavioral therapy (CBT) and mindfulness, enabling users to objectively assess their psychological state and learn appropriate coping strategies. Additionally, its AI-driven conversational functionality allows users to engage in daily mental health care. Participants in this study will be instructed to use specific features of the app, Check-in & Check-out, Psychology Learning Course, and AI Chat Function, for approximately 20 minutes per day over a four-week period.
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
| 18 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
1.Individuals who regularly use a smartphone.
2.Individuals who can understand Japanese.
3.Individuals who can provide written informed consent for voluntary participation in the study.
Key exclusion criteria
1.Individuals who have been diagnosed with a mental disorder and are undergoing treatment.
Target sample size
40
Research contact person
Name of lead principal investigator
| 1st name | Ryu |
| Middle name | |
| Last name | Kobayashi |
Organization
International University of Health and Welfare
Division name
Department of Occupational Therapy, School of Halth Science at Narita
Zip code
286-8686
Address
4-3 Kozunomori, Narita City Chiba
TEL
0476207718
rkobayashi@ihwg.jp
Public contact
Name of contact person
| 1st name | Ryu |
| Middle name | |
| Last name | Kobayashi |
Organization
International University of Health and Welfare
Division name
Department of Occupational Therapy, School of Halth Science at Narita
Zip code
286-8686
Address
4-3 Kozunomori, Narita City Chiba
TEL
0476207718
Homepage URL
rkobayashi@iuhw.ac.jp
Sponsor or person
Institute
International University of Health and Welfare
Institute
Department
Personal name
Ryu Kobayashi
Funding Source
Organization
International University of Health and Welfare
Organization
Division
Category of Funding Organization
Self funding
Nationality of Funding Organization
Japan
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
International University of Health and Welfare
Address
4-3 Kozunomori, Narita City Chiba
Tel
0476207718
rkobayashi@ihwg.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 | 07 | Month | 10 | 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 | 07 | Month | 10 | Day |
Date of IRB
| 2025 | Year | 07 | Month | 10 | Day |
Anticipated trial start date
| 2025 | Year | 07 | Month | 10 | 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
Management information
Registered date
| 2025 | Year | 07 | Month | 10 | Day |
Last modified on
| 2025 | Year | 07 | Month | 10 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000065215
