UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000026513
Receipt number 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 2024/03/18 08:49:48

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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 Noriyuki
Middle name
Last name Enomoto

Organization

Hamamatsu University School of Medicine

Division name

Health administration center

Zip code

4313192

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 Noriyuki
Middle name
Last name Enomoto

Organization

Hamamatsu University School of Medicine

Division name

Health administration center

Zip code

4313192

Address

1-20-1 Handayama, Higashiku, Hamamatsu, Japan

TEL

+81-53-435-2158

Homepage URL


Email

norieno@hama-med.ac.jp


Sponsor or person

Institute

Hamamatsu University School of Medicine

Institute

Department

Personal name



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

Hamamatsu University School of Medicine

Address

1-20-1 Handayama, Hamamamatsu, Japan

Tel

81-053-435-2158

Email

norieno@hama-med.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

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

Completed

Date of protocol fixation

2017 Year 03 Month 02 Day

Date of IRB

2017 Year 03 Month 13 Day

Anticipated trial start date

2017 Year 03 Month 27 Day

Last follow-up date

2024 Year 03 Month 16 Day

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

2024 Year 03 Month 18 Day



Link to view the page

Value
https://center6.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