UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000045615 |
|---|---|
| Receipt number | R000052079 |
| Scientific Title | Improvement of a mental health measurement scale and establishment of cutoff values among undergraduate and graduate students in science departments |
| Date of disclosure of the study information | 2021/10/01 |
| Last modified on | 2026/03/08 20:55:49 |
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Basic information
Public title
Improvement of a mental health measurement scale and establishment of cutoff values among undergraduate and graduate students in science departments
Acronym
Improvement of a mental health measurement scale and establishment of cutoff values among undergraduate and graduate students in science departments
Scientific Title
Improvement of a mental health measurement scale and establishment of cutoff values among undergraduate and graduate students in science departments
Scientific Title:Acronym
Improvement of a mental health measurement scale and establishment of cutoff values among undergraduate and graduate students in science departments
Region
| Japan |
Condition
Condition
N/A
Classification by specialty
| Not applicable |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
Improving a self-administered scale of mental health and establishing a cutoff value for predicting current mental health problem and to take a leave or dropout.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Exploratory
Trial characteristics_2
Pragmatic
Developmental phase
Not applicable
Assessment
Primary outcomes
University Personality Inventory shortform
Key secondary outcomes
1) K10: mental health scale
2) PASAN: positive / negative affect scale
3) SWLS: satisfaction with life scale
4) Whether or not to take a leave or dropout up to 5 years later
Base
Study type
Observational
Study design
Basic design
Randomization
Randomization unit
Blinding
Control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
Purpose of intervention
Type of intervention
Interventions/Control_1
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
| 30 | years-old | > |
Gender
Male and Female
Key inclusion criteria
Inclusion criteria were as follows: 1) subject's age is over 18 and under 30; 2) subject (if subject is minor, subject and parental authority) can understand the contents of this study and express written consent to participate; 3)Japanese nationality; 4) undergraduate and graduate students, department of science.
Key exclusion criteria
Exclusion criteria were as follows: 1) subjects expect to feel emotional distress to join this study ; 2)subject (and/or parental authority) do not understand this study.
Target sample size
500
Research contact person
Name of lead principal investigator
| 1st name | Masashi |
| Middle name | |
| Last name | Iwabuchi |
Organization
Graduate school of Science, Tohoku University
Division name
Campus life Support Office
Zip code
980-8578
Address
6-3, Aramaki Aza-Aoba, Aoba-ku, Sendai City, Miyagi Prefecture, Japan
TEL
022-795-6706
soudan@mail.sci.tohoku.ac.jp
Public contact
Name of contact person
| 1st name | Masashi |
| Middle name | |
| Last name | Iwabuchi |
Organization
Graduate school of Science, Tohoku University
Division name
Campus life Support Office
Zip code
980-8578
Address
6-3, Aramaki Aza-Aoba, Aoba-ku, Sendai City, Miyagi Prefecture, Japan
TEL
022-795-6706
Homepage URL
soudan@mail.sci.tohoku.ac.jp
Sponsor or person
Institute
Graduate school of Science, Tohoku University
Institute
Department
Personal name
Funding Source
Organization
Graduate school of Science, Tohoku University
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
Research Ethics Committee, School of Medicine, Tohoku University
Address
Seiryo-machi, 2-1, Sendai City, Japan
Tel
022-728-4105
med-kenkyo@grp.tohoku.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
東北大学大学院理学研究科
Other administrative information
Date of disclosure of the study information
| 2021 | Year | 10 | Month | 01 | 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
472
Results
The analysis based on the IRT was performed (n=472). Model comparison indicated that a bi-factor model was adopted for the revised version of the UPI16T-GR. Examination of test information functions did not support Hypothesis 1, which posited that the UPI20-GR would demonstrate higher reliability than the UPI16T-GR at lower latent trait scores. However, criterion-related validity was verified through correlations with other measures, and cutoff values for academic withdrawal risk were established.
Results date posted
| 2026 | Year | 02 | Month | 09 | Day |
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
Completed
Date of protocol fixation
| 2021 | Year | 09 | Month | 29 | Day |
Date of IRB
| 2021 | Year | 09 | Month | 29 | Day |
Anticipated trial start date
| 2021 | Year | 10 | Month | 13 | Day |
Last follow-up date
| 2025 | Year | 10 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
| 2025 | Year | 10 | Month | 31 | Day |
Date analysis concluded
| 2026 | Year | 02 | Month | 08 | Day |
Other
Other related information
The research design is a prospective study using a questionnaire method. The questionnaire survey will be conducted in October 2021 for undergraduate and graduate students belonging to a department of science. If the target sample size is not met, the questionnaire survey will be conducted the following year with the same content. However, if the target sample size will not be met until October 2025, the data obtained by then will be used for analysis. For those who have cooperated in the survey over multiple years, the most recent response data will be used for analysis. In October 2025, we will confirm whether the survey participants take leave or drop out for the period from October 2021 to October 2025. As the target participant base was not met during the October 2023 survey, the same survey will be conducted in October 2024.
Management information
Registered date
| 2021 | Year | 09 | Month | 30 | Day |
Last modified on
| 2026 | Year | 03 | Month | 08 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000052079
