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Name:
UMIN ID:

Recruitment status Enrolling by invitation
Unique ID issued by UMIN UMIN000026513
Receipt No. R000030222
Scientific Title Screening for students with mental health disorders in a medical university by a novel and brief questionnaire.
Date of disclosure of the study information 2017/03/27
Last modified on 2017/09/11

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Basic information
Public title Screening for students with mental health disorders in a medical university by a novel and brief questionnaire.
Acronym Screening for students with mental health disorders in a medical university by a novel and brief questionnaire.
Scientific Title Screening for students with mental health disorders in a medical university by a novel and brief questionnaire.
Scientific Title:Acronym Screening for students with mental health disorders in a medical university by a novel and brief questionnaire.
Region
Japan

Condition
Condition Students with mental health disorders in a medical university
Classification by specialty
Psychosomatic Internal Medicine Psychiatry Adult
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 To verify whether a novel and brief questionnaire, including Kessler 6, can detect students with mental health disorders in a medical university.
Basic objectives2 Others
Basic objectives -Others To follow the change in scores of a novel and brief questionnaire including Kessler 6.
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes Detection rate of students with mental health disorders by a novel brief and questionnaire including Kessler 6.
Key secondary outcomes Seasonal and annual change in scores of a novel and brief questionnaire.
Relationship between scores of a novel and brief questionnaire and that of university personality inventory (UPI).
Detection rates of students with dysphoria or Attention Deficit Hyperactivity Disorder (ADHD) or Autism Spectrum Disorder (ASD).

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 Prevention
Type of intervention
Behavior,custom
Interventions/Control_1 1 or 2 times per year for 5 years
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 1. Students who get into Hamamatsu University School of Medicine in April each year.
2. Students who agree to be part of this study.

Key exclusion criteria 1. Students who are absent from school.
2. Students that Doctors deem inappropriate for this study.
Target sample size 900

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Noriyuki Enomoto
Organization Hamamatsu University School of Medicine
Division name Health administration center
Zip code
Address 1-20-1 Handayama, Higashiku, Hamamatsu, Japan
TEL +81-53-435-2158
Email norieno@hama-med.ac.jp

Public contact
Name of contact person
1st name
Middle name
Last name Noriyuki Enomoto
Organization Hamamatsu University School of Medicine
Division name Health administration center
Zip code
Address 1-20-1 Handayama, Higashiku, Hamamatsu, Japan
TEL +81-53-435-2158
Homepage URL
Email norieno@hama-med.ac.jp

Sponsor
Institute Hamamatsu University School of Medicine
Institute
Department

Funding Source
Organization Hamamatsu University School of Medicine
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
Address
Tel
Email

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
2017 Year 03 Month 27 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
2017 Year 03 Month 02 Day
Date of IRB
Anticipated trial start date
2017 Year 03 Month 27 Day
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information none

Management information
Registered date
2017 Year 03 Month 12 Day
Last modified on
2017 Year 09 Month 11 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000030222

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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