UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000059683 |
|---|---|
| Receipt number | R000068078 |
| Scientific Title | Development of a mental health care program that combines digital technology using AI and wearable devices with an agricultural work program |
| Date of disclosure of the study information | 2025/11/07 |
| Last modified on | 2025/11/07 13:10:22 |
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Basic information
Public title
Development of a mental health care program that combines digital technology using AI and wearable devices with an agricultural work program
Acronym
Development of a mental health care program utilizing digital technology and agricultural work
Scientific Title
Development of a mental health care program that combines digital technology using AI and wearable devices with an agricultural work program
Scientific Title:Acronym
Development of a mental health care program utilizing digital technology and agricultural work
Region
| Japan |
Condition
Condition
Healthy adults and people with mental health problems
Classification by specialty
| Psychosomatic Internal Medicine | Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To verify the effectiveness of a mental health care program that combines digital technology with agricultural work
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Changes in salivary cortisol concentrations before and after agricultural work
Key secondary outcomes
Changes in psychological-related questionnaires (POMS 2, general mood states, emotional relaxation scale), subjectively evaluation-related questionnaire (physical condition, psychological fatigue, physical fatigue), and facial expression analysis before and after agricultural work.
Semi-structured interview after agricultural work.
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
| Behavior,custom |
Interventions/Control_1
2 hours of Agricultural work
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
Men and women aged over 18 years who understood the purpose and contents of the study and provided written informed consent
Key exclusion criteria
1. Limited physical activity
2. Restrictions on outdoor activities
3. Have an allergic disease that prevents carrying out agricultural work
4. Difficulty using public transportation
5. Individuals who are judged as unsuitable for the study by the investigator for other reasons
Target sample size
10
Research contact person
Name of lead principal investigator
| 1st name | Yuji |
| Middle name | |
| Last name | OURA |
Organization
Tokyo University of Agriculture
Division name
Department of Food Environment Economics
Zip code
156-8502
Address
1-1-1 Sakuragaoka, Setagaya-ku, Tokyo
TEL
03-5477-2372
yo205309@nodai.ac.jp
Public contact
Name of contact person
| 1st name | Reiko |
| Middle name | |
| Last name | MACHIDA |
Organization
Tokyo University of Agriculture
Division name
Department of Regional Regeneration Science
Zip code
156-8502
Address
1-1-1 Sakuragaoka, Setagaya-ku, Tokyo
TEL
03-5477-5950
Homepage URL
r3machid@nodai.ac.jp
Sponsor or person
Institute
Tokyo Univeristy of Agriculture
Institute
Department
Personal name
Funding Source
Organization
Tokyo University of Agriculture
Organization
Division
Category of Funding Organization
Other
Nationality of Funding Organization
Other related organizations
Co-sponsor
Tokyo University of Information Sciences
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Tokyo University of Agriculture, The Ethical Committee of Experiment and survey for Human
Address
1-1-1 Sakuragaoka, Setagaya-ku, Tokyo
Tel
03-5477-2532
human@nodai.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 | 11 | Month | 07 | 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
Enrolling by invitation
Date of protocol fixation
| 2025 | Year | 10 | Month | 08 | Day |
Date of IRB
| 2025 | Year | 10 | Month | 07 | Day |
Anticipated trial start date
| 2025 | Year | 10 | Month | 08 | 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
| 2025 | Year | 11 | Month | 07 | Day |
Last modified on
| 2025 | Year | 11 | Month | 07 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000068078
