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Name:
UMIN ID:

Recruitment status Enrolling by invitation
Unique ID issued by UMIN UMIN000045615
Receipt No. 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 2021/10/13

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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 2000

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
Email 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
Email soudan@mail.sci.tohoku.ac.jp

Sponsor
Institute Graduate school of Science, Tohoku University
Institute
Department

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
Email 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
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
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
Date analysis concluded

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. In October 2025, we will confirm whether the survey participants take to leave or dropout for the period from October 2021 to October 2025.

Management information
Registered date
2021 Year 09 Month 30 Day
Last modified on
2021 Year 10 Month 13 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000052079

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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