UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000045716
Receipt number R000052184
Scientific Title A survey on changes in knowledge of psychological first aid and self-efficacy among participants of a training session for using the Manual for Responding to Mental Health Problems under COVID-19 Epidemic
Date of disclosure of the study information 2021/10/30
Last modified on 2023/04/13 18:29:16

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Basic information

Public title

A survey on changes in knowledge of psychological first aid and self-efficacy among participants of a training session for using the Manual for Responding to Mental Health Problems under COVID-19 Epidemic

Acronym

A survey on changes in knowledge of psychological first aid and self-efficacy among participants of a training session for using the Manual for Responding to Mental Health Problems under COVID-19 Epidemic

Scientific Title

A survey on changes in knowledge of psychological first aid and self-efficacy among participants of a training session for using the Manual for Responding to Mental Health Problems under COVID-19 Epidemic

Scientific Title:Acronym

A survey on changes in knowledge of psychological first aid and self-efficacy among participants of a training session for using the Manual for Responding to Mental Health Problems under COVID-19 Epidemic

Region

Japan


Condition

Condition

None

Classification by specialty

Adult

Classification by malignancy

Others

Genomic information

NO


Objectives

Narrative objectives1

To investigate whether the knowledge of psychological first aid and the self-efficacy of responding to counselors changed in participants who attended a training session for using the "Manual for Responding to Mental Health Problems in a COVID-19 Epidemic.

#2 To survey the participants of the training session on the problems of the manual.

Basic objectives2

Others

Basic objectives -Others

To survey the participants of the training session on the problems of the manual.

Trial characteristics_1


Trial characteristics_2


Developmental phase



Assessment

Primary outcomes

Changing of a knowledge of psychological first aid making comparison between before, after and 6 months after training session.

Key secondary outcomes

Changing of a self efficacy making comparison between before, after and 6 months after training session.


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

Educational,Counseling,Training

Type of intervention

Other

Interventions/Control_1

Training session for the use of the Manual for Responding to Mental Health Problems under a COVID-19 Epidemic

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

20 years-old <=

Age-upper limit


Not applicable

Gender

Male and Female

Key inclusion criteria

#1 Staff at mental health welfare centers nationwide, or research subcontractors and research participants in the AMED project of the Construction of an Emergency Remote Response Mental Health Care System for Social Change caused COVID-19 and Verification of Its Effectiveness in Promoting Practical Application,"
#2 Those who participated in the training session for using the Manual for Responding to Mental Health Problems under a New Coronavirus Epidemic

Key exclusion criteria

The researchers who are member of this study and are research subcontributors to the AMED research and development project "Construction of an Emergency Remote Response Mental Health Care System under Social Changes caused COVID-19 and Verification of Its Effectiveness in Promoting Practical Application.

Target sample size

96


Research contact person

Name of lead principal investigator

1st name Tomohiro
Middle name
Last name Nakao

Organization

Graduate School of Medical Sciences, Kyushu University

Division name

Department of Neuropsychiatry

Zip code

8128582

Address

3-1-1 Maidashi, Higashi-ku, Fukuoka

TEL

092-642-5620

Email

nakao.tomohiro.275@m.kyuhsu-u.ac.jp


Public contact

Name of contact person

1st name Keitaro
Middle name
Last name Murayama

Organization

Kyushu University Hospital

Division name

Department of psychiatry

Zip code

812-8582

Address

3-1-1 Maidashi, Higashi-ku, Fukuoka

TEL

092-642-5627

Homepage URL


Email

murayama.keitaro.003@m.kyushu-u.ac.jp


Sponsor or person

Institute

Ministry of Health, Labour, and Welfare

Institute

Department

Personal name



Funding Source

Organization

Ministry of Health, Labour, and Welfare

Organization

Division

Category of Funding Organization

Japanese Governmental office

Nationality of Funding Organization



Other related organizations

Co-sponsor


Name of secondary funder(s)



IRB Contact (For public release)

Organization

Kyushu University Medical School District Departments and Hospitals Ethics Review Committee

Address

3-1-1 Maidashi, Higashi-ku, Fukuoka

Tel

092-642-5775

Email

byskenkyu@jimu.kyushu-u.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

2021 Year 10 Month 30 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

2021 Year 09 Month 21 Day

Date of IRB

2021 Year 09 Month 21 Day

Anticipated trial start date

2021 Year 09 Month 26 Day

Last follow-up date

2023 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

2021 Year 10 Month 11 Day

Last modified on

2023 Year 04 Month 13 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000052184