UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000051164
Receipt number R000058334
Scientific Title Suicide prevention for university students: A feasibility study for online counseling
Date of disclosure of the study information 2023/05/25
Last modified on 2023/05/25 17:16:58

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Basic information

Public title

Suicide prevention for university students: A feasibility study for online counseling

Acronym

Suicide prevention for university students: A feasibility study for online counseling

Scientific Title

Suicide prevention for university students: A feasibility study for online counseling

Scientific Title:Acronym

Suicide prevention for university students: A feasibility study for online counseling

Region

Japan


Condition

Condition

Non clinical population, Psychiatric disorder

Classification by specialty

Psychosomatic Internal Medicine Psychiatry Adult

Classification by malignancy

Others

Genomic information

NO


Objectives

Narrative objectives1

To verify whether early identification of university students at risk of suicide and guidance of online psychological counseling, in addition to guidance at on-campus health management centers can reduce the overall risk of suicide.

Basic objectives2

Others

Basic objectives -Others

To examine the feasibility of a system that identifies students at high risk of potential suicide and provides early intervention.

Trial characteristics_1


Trial characteristics_2


Developmental phase



Assessment

Primary outcomes

Suicide risk

Key secondary outcomes

Depression, Anxiety, Loneliness, Psychological well-being


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

Other

Interventions/Control_1

Provide information on online counseling

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. Second-year student at Tokyo Medical and Dental University, Faculty of Medicine
2. Students who responded to previous on-campus surveys
3. Students who give consent for their responses to previous on-campus surveys to be collated with this study data in a personally identifiable form.

Key exclusion criteria

NA

Target sample size

80


Research contact person

Name of lead principal investigator

1st name Takeo
Middle name
Last name Fujiwara

Organization

Tokyo Medical and Dental University

Division name

Department of Global Public Health

Zip code

113-8519

Address

1-5-45, Yushima, Bunkyo-ku, Tokyo

TEL

0358035188

Email

fujiwara.hlth@tmd.ac.jp


Public contact

Name of contact person

1st name Aya
Middle name
Last name Isumi

Organization

Tokyo Medical and Dental University

Division name

Department of Health Policy

Zip code

113-8519

Address

1-5-45, Yushima, Bunkyo-ku, Tokyo

TEL

03580354031

Homepage URL


Email

isumi.hlth@tmd.ac.jp


Sponsor or person

Institute

Tokyo Medical and Dental University

Institute

Department

Personal name



Funding Source

Organization

Japan Suicide Countermeasures Promotion Center (JSCP)

Organization

Division

Category of Funding Organization

Non profit foundation

Nationality of Funding Organization



Other related organizations

Co-sponsor


Name of secondary funder(s)



IRB Contact (For public release)

Organization

Tokyo Medical and Dental University

Address

1-5-45, Yushima, Bunkyo-ku, Tokyo

Tel

03-5803-5096

Email

syomu1.adm@tmd.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

2023 Year 05 Month 25 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

Preinitiation

Date of protocol fixation

2023 Year 05 Month 01 Day

Date of IRB


Anticipated trial start date

2023 Year 07 Month 15 Day

Last follow-up date

2025 Year 03 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

2023 Year 05 Month 25 Day

Last modified on

2023 Year 05 Month 25 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000058334