UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000057908 |
|---|---|
| Receipt number | R000066193 |
| Scientific Title | The effectiveness of an mHealth app which uses a deep learning model to promote physical activity and improve depression and anxiety: a randomized controlled trial |
| Date of disclosure of the study information | 2025/05/26 |
| Last modified on | 2025/08/19 14:41:42 |
* 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
The effectiveness of an mHealth app "ASHARE" which uses a deep learning model to promote physical activity and improve depression and anxiety: a randomized controlled trial
Acronym
The effectiveness of an mHealth app "ASHARE": a randomized controlled trial
Scientific Title
The effectiveness of an mHealth app which uses a deep learning model to promote physical activity and improve depression and anxiety: a randomized controlled trial
Scientific Title:Acronym
The effectiveness of an mHealth app which uses a deep learning model to promote physical activity and improve depression and anxiety: a randomized controlled trial
Region
| Japan |
Condition
Condition
Depression and anxiety
Classification by specialty
| Neurology | Psychiatry | Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
The present study aims to conduct a randomized controlled trial that examines the effectiveness of a smartphone application "ASHARE" on depression and anxiety and physical activity among workers.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Confirmatory
Trial characteristics_2
Pragmatic
Developmental phase
Not applicable
Assessment
Primary outcomes
Depression and anxiety (K6)
Key secondary outcomes
Physical activity
1) Questionnaire: GPAQ, Bull et al., 2009)
2) The duration of digitally recorded physical activity (for the intervention group only)
Number of logins to the app (for the intervention group only)
Usefulness evaluation: acceptability, appropriateness, feasibility, satisfaction with the program (iOSDMH, Sasaki et al., 2021)
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Open -no one is blinded
Control
Active
Stratification
YES
Dynamic allocation
NO
Institution consideration
Institution is not considered as adjustment factor.
Blocking
YES
Concealment
Central registration
Intervention
No. of arms
2
Purpose of intervention
Prevention
Type of intervention
| Behavior,custom | Other |
Interventions/Control_1
Use of the smartphone app "ASHARE"
The principal investigator will provide participants assigned to the intervention group with access to a smartphone app "ASHARE" for three months. The ASHARE is a native app compatible with iOS (version 12.0 or later) and Android (version 5.0 or later). It is available for free download from the App Store and Google Play, respectively. This application is designed to promote physical activity by incorporating basic behavior change techniques such as self-monitoring, feedback, and data sharing among users. Physical activity data are recorded through integration with Apple Health (for iOS users) and Google Fit (for Android users). In addition, the application utilizes a deep learning model (long short-term memory, LSTM) to predict the user's daily levels of depression and anxiety based on data from the previous day.
It is not mandatory for participants to use the app and they may access it at their own discretion. Ideally, participants are expected to use the application for about five minutes per day to review their physical activity patterns and the predicted mental health scores, while aiming to increase their physical activity levels.
To enhance program adherence, the research team will send reminder emails every two weeks to encourage app usage. The application will also send daily notifications at 6:00 AM to inform participants of their latest predicted depression and anxiety scores via the smartphone's notification system. The research team will monitor app usage, including login frequency and physical activity time, through the management dashboard.
Interventions/Control_2
Active control
Workers engaged in worksites in this group will be asked to download and read a booklet that provides basic information about stress for 6 months. No assistance other than the booklet will be provided.
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
Eligible employees within work units will be
1) aged 18 years or older,
2) capable of completing questionnaires in Japanese
3) owning a personal smartphone
Key exclusion criteria
Employees were excluded if they were absent during the enrollment period or had been absent due to sickness within the previous 12 months.
Target sample size
800
Research contact person
Name of lead principal investigator
| 1st name | Kazuhiro |
| Middle name | |
| Last name | Watanabe |
Organization
Kitasato University School of Medicine
Division name
Department of Public Health
Zip code
252-0374
Address
1-15-1 Kitazato, Minami-ku, Sagamihara 252-0374, Japan
TEL
+81-42-778-9352
kzwatan@kitasato-u.ac.jp
Public contact
Name of contact person
| 1st name | Kazuhiro |
| Middle name | |
| Last name | Watanabe |
Organization
Kitasato University School of Medicine
Division name
Department of Public Health
Zip code
252-0374
Address
1-15-1 Kitazato, Minami-ku, Sagamihara 252-0374, Japan
TEL
+81-42-778-9352
Homepage URL
kzwatan@kitasato-u.ac.jp
Sponsor or person
Institute
Kitasato University
Institute
Department
Personal name
Funding Source
Organization
Japan Agency for Medical Research and Development: AMED
Organization
Division
Category of Funding Organization
Japanese Governmental office
Nationality of Funding Organization
Japan
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Kitasato University Medical Ethics Organization (KMEO)
Address
1-15-1 Kitazato, Minami-ku, Sagamihara 252-0373, Japan
Tel
+81-42-778-8273
rinri@med.kitasato-u.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
| 2025 | Year | 05 | Month | 26 | 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
No longer recruiting
Date of protocol fixation
| 2025 | Year | 05 | Month | 26 | Day |
Date of IRB
| 2025 | Year | 05 | Month | 19 | Day |
Anticipated trial start date
| 2025 | Year | 06 | Month | 01 | Day |
Last follow-up date
| 2026 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
| 2026 | Year | 04 | Month | 30 | Day |
Date trial data considered complete
| 2026 | Year | 06 | Month | 30 | Day |
Date analysis concluded
| 2026 | Year | 06 | Month | 30 | Day |
Other
Other related information
Management information
Registered date
| 2025 | Year | 05 | Month | 19 | Day |
Last modified on
| 2025 | Year | 08 | Month | 19 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000066193
