UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000051383 |
|---|---|
| Receipt number | R000058211 |
| Scientific Title | Evaluation of a mobile health application for mental health support among Vietnamese migrants in Japan |
| Date of disclosure of the study information | 2023/08/31 |
| Last modified on | 2026/06/03 09:51:18 |
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Basic information
Public title
Evaluation of a mobile health application for mental health support among Vietnamese migrants in Japan
Acronym
Evaluation of a mobile health application for mental health support among Vietnamese migrants in Japan
Scientific Title
Evaluation of a mobile health application for mental health support among Vietnamese migrants in Japan
Scientific Title:Acronym
Evaluation of a mobile health application for mental health support among Vietnamese migrants in Japan
Region
| Japan |
Condition
Condition
Depressive and anxiety symptoms (exploratory)
Classification by specialty
| Not applicable |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
Examine the impact of applications on improving mental health among Vietnamese migrants in Japan
Basic objectives2
Others
Basic objectives -Others
Feasibility and acceptability
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Feasibility and acceptability
Key secondary outcomes
Change scores for PHQ-9 and GAD-7 (3 months minus baseline)
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Non-randomized
Randomization unit
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
| Behavior,custom |
Interventions/Control_1
Engage with the "Kobe Cuu" application for 12 consecutive weeks
Interventions/Control_2
Engage with the "Kobe Cuu" application without functions of "health status visualization" and "consultation chat" for 12 consecutive weeks
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
| 65 | years-old | > |
Gender
Male and Female
Key inclusion criteria
Has Vietnamese citizenship
Key exclusion criteria
Undergoing treatment for mental illness
Target sample size
14
Research contact person
Name of lead principal investigator
| 1st name | Tadashi |
| Middle name | |
| Last name | Yamashita |
Organization
Kobe City College of Nursing
Division name
Nusing
Zip code
651-2103
Address
3-4 Gakuennishi-Machi, Nishi-ku, Kobe, Hyogo, 651-2103, Japan
TEL
078-794-8052
yamashita@tr.kobe-ccn.ac.jp
Public contact
Name of contact person
| 1st name | Tadashi |
| Middle name | |
| Last name | Yamashita |
Organization
Kobe City College of Nursing
Division name
Nursing
Zip code
651-2103
Address
3-4 Gakuennishi-Machi, Nishi-ku, Kobe, Hyogo, 651-2103, Japan
TEL
078-794-8052
Homepage URL
yamashita@tr.kobe-ccn.ac.jp
Sponsor or person
Institute
Kobe City College of Nursing
Institute
Department
Personal name
Funding Source
Organization
Japan Society for the Promotion of Science
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
Ethics Review Committee, Department of Nursing, Kobe City College of Nursing
Address
3-4 Gakuennishi-Machi, Nishi-ku, Kobe, Hyogo, 651-2103, Japan
Tel
078-794-8080
yamashita@tr.kobe-ccn.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
| 2023 | Year | 08 | Month | 31 | Day |
Related information
URL releasing protocol
https://rctportal.mhlw.go.jp/detail/um?trial_id=UMIN000051383
Publication of results
Unpublished
Result
URL related to results and publications
https://rctportal.mhlw.go.jp/detail/um?trial_id=UMIN000051383
Number of participants that the trial has enrolled
14
Results
A 3-month pilot study of a Vietnamese-language, counselor-linked mental health app (Kobe Cuu) among Vietnamese residents in Japan. Fourteen participants were allocated to intervention (n=7) or control (n=7). All intervention participants completed at least one self-check (median 4, range 2-13). Acceptability was favorable (4/7 respondents endorsed agreement on all items). Mean PHQ-9 change: -1.6 (SD 3.6) intervention, -1.5 (SD 3.8) control.
Results date posted
| 2026 | Year | 06 | Month | 01 | Day |
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
Intervention group (n=7): aged 20-39 years, 4 male/3 female, baseline PHQ-9 mean 5.0 (SD 3.3), GAD-7 mean 2.7 (SD 2.5). Control group (n=7): aged 18-46 years, 5 male/2 female, baseline PHQ-9 mean 5.7 (SD 4.9), GAD-7 mean 3.6 (SD 3.7). All participants were Vietnamese residents in Japan with Android smartphones.
Participant flow
14 participants enrolled and allocated (intervention n=7, control n=7). 3-month questionnaire returned: intervention 4/7 (57.1%), control 5/7 (71.4%). Reason for non-response: no reply to push notifications and email reminders; no formal withdrawals.
Adverse events
No adverse events were identified during the study period.
Outcome measures
Primary outcomes: feasibility (enrollment, follow-up rates, engagement indicators) and acceptability (3-month questionnaire). Secondary outcomes (exploratory): change scores for PHQ-9 and GAD-7 (3-month minus baseline).
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
Completed
Date of protocol fixation
| 2023 | Year | 08 | Month | 31 | Day |
Date of IRB
| 2023 | Year | 12 | Month | 15 | Day |
Anticipated trial start date
| 2023 | Year | 10 | Month | 01 | Day |
Last follow-up date
| 2025 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
| 2025 | Year | 03 | Month | 31 | Day |
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2023 | Year | 06 | Month | 19 | Day |
Last modified on
| 2026 | Year | 06 | Month | 03 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000058211
