UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000056493 |
|---|---|
| Receipt number | R000064542 |
| Scientific Title | Development of Practical Training Methods Using Outreach Approaches for Students with Mental Health Challenges |
| Date of disclosure of the study information | 2024/12/18 |
| Last modified on | 2025/12/19 11:07:05 |
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Basic information
Public title
Development of Practical Training Methods Using Outreach Approaches for Students with Mental Health Challenges
Acronym
Development of Practical Training Methods Using Outreach Approaches for Students with Mental Health Challenges
Scientific Title
Development of Practical Training Methods Using Outreach Approaches for Students with Mental Health Challenges
Scientific Title:Acronym
Development of Practical Training Methods Using Outreach Approaches for Students with Mental Health Challenges
Region
| Japan |
Condition
Condition
Hikikomori (Social withdrawal syndrome ), apathy, school refusal
Classification by specialty
| Psychiatry |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
This study aims to scientifically examine whether improvements in daily life rhythms can alleviate mental health disturbances in young individuals.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
depression scale (patient health questionnarie-9: PHQ-9)
Key secondary outcomes
Daily activity, sleep duration, sleep rhythm, self-esteem IAT
Base
Study type
Interventional
Study design
Basic design
Single arm
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Self control
Stratification
NO
Dynamic allocation
NO
Institution consideration
Institution is not considered as adjustment factor.
Blocking
NO
Concealment
Intervention
No. of arms
1
Purpose of intervention
Treatment
Type of intervention
| Behavior,custom |
Interventions/Control_1
Participants were provided with wearable devices, and the intervention consisted of two components: (1) conducting home visits in the morning to encourage wakefulness, and (2) providing lifestyle guidance based on data obtained from the wearable devices.
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
Students who visited the Tsukuba University Health Center
Key exclusion criteria
Individuals with strong suicidal ideation or those diagnosed with severe depression or schizophrenia, who were deemed to be at high clinical risk, were excluded from the intervention.
Target sample size
30
Research contact person
Name of lead principal investigator
| 1st name | Yuki |
| Middle name | |
| Last name | Shiratori |
Organization
University of Tsukuba
Division name
University Health Center
Zip code
305-8577
Address
1-1-1 Tennoudai, Tsukuba, Ibaraki.
TEL
0298532411
yuki.shiratori@md.tsukuba.ac.jp
Public contact
Name of contact person
| 1st name | Yuki |
| Middle name | |
| Last name | Shiratori |
Organization
University Health Center
Division name
University Health Center
Zip code
305-8577
Address
1-1-1 Tennoudai, Tsukuba, Ibaraki.
TEL
0298532411
Homepage URL
yuki.shiratori@md.tsukuba.ac.jp
Sponsor or person
Institute
University of Tsukuba
Institute
Department
Personal name
Funding Source
Organization
Ministry of Education, Culture, Sports, Science and Technology
Organization
Division
Category of Funding Organization
Japanese Governmental office
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
University of Tsukuba
Address
1-1-1 Tennodai, Tsukuba, Ibaraki.
Tel
0298532411
yuki.shiratori@md.tsukuba.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
| 2024 | Year | 12 | Month | 18 | Day |
Related information
URL releasing protocol
https://center6.umin.ac.jp/cgi-open-bin/ctr/ctr_view.cgi?recptno=R000064542
Publication of results
Published
Result
URL related to results and publications
https://jssp42.umin.jp/schedule.html
Number of participants that the trial has enrolled
5
Results
SRI improved in 4 of 5 patients but did not reach statistical significance; PHQ-9 improved.
Results date posted
| 2025 | Year | 06 | Month | 19 | Day |
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
five male students with a mean age of 21 years
Participant flow
Participants were recruited from students visiting the psychiatric outpatient department at Tsukuba University Health Center, Japan, between January 2020 and April 2023.
Adverse events
none
Outcome measures
PHQ-9, SRI
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
Main results already published
Date of protocol fixation
| 2020 | Year | 01 | Month | 15 | Day |
Date of IRB
| 2020 | Year | 01 | Month | 15 | Day |
Anticipated trial start date
| 2020 | Year | 01 | Month | 15 | Day |
Last follow-up date
| 2024 | Year | 01 | 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
| 2024 | Year | 12 | Month | 18 | Day |
Last modified on
| 2025 | Year | 12 | Month | 19 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000064542
