UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	Application of Mental Health First Aid to medical staff : Single-arm study at Kyoto University Hospital
Title of the study (Brief title)	Application of Mental Health First Aid to medical staff
Region	Japan

Condition
Condition	Nurses/Medical staff
Classification by specialty	Adult
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	To evaluate the effectiveness of applied Mental Health First Aid to increase knowledge and skills for nurses/medical staff and to deal with the person with depression and/or suicidal thoughts at primary care setting.
Basic objectives2	Efficacy
Basic objectives -Others
Trial characteristics_1	Confirmatory
Trial characteristics_2	Pragmatic
Developmental phase	Not applicable

Assessment
Primary outcomes	The change of Suicide Intervention Response Inventory (SIRI) socre just after and one month later the intervention
Key secondary outcomes	The change of confidence and knowledge level related to suicide intervention just after and one month later the intervention

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	Behavior,custom
Interventions/Control_1	Mental Health First Aid (MHFA) program including lecture and role-play
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	Not applicable
Age-upper limit	Not applicable
Gender	Male and Female
Key inclusion criteria	Nurses and medical staff working at Kyoto University Hospital
Key exclusion criteria	None
Target sample size	60

Research contact person
Name of lead principal investigator	Takahiro Kato
Organization	Kyushu University
Division name	Innovation Center for Medical Redox Navigation
Address	West Wing 6F, 1-1, Maidashi, Higashi-ku, Fukuoka-shi, Fukuoka 812-8582, Japan
TEL	092-642-6031
Email	takahiro@npsych.med.kyushu-u.ac.jp

Public contact
Name of contact person	Yukako Nakagami
Organization	Kyoto University Graduate School of Medicine
Division name	Department of Psychiatry
Address	54 Shogoin-Kawahara-cho Sakyo-ku Kyoto 606-8507 Japan
TEL	075-751-4947
Homepage URL
Email	nakagami-kyt@umin.ac.jp

Sponsor
Institute	Department of Psychiatry Kyoto University Graduate School of Medicine
Institute
Department

Funding Source
Organization	Grant for clinical cancer research from the Ministry of Health, Labour and Welfare, Japan
Organization
Division
Category of Funding Organization	Japanese Governmental office
Nationality of Funding Organization

Other related organizations
Co-sponsor
Name of secondary funｄer(s)

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	2015 Year 10 Month 01 Day

Progress
Recruitment status	Completed
Date of protocol fixation	2015 Year 10 Month 01 Day
Anticipated trial start date	2015 Year 10 Month 01 Day
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Related information
URL releasing protocol
Publication of results	Published
URL releasing results
Results
Other related information

Management information
Registered date	2015 Year 08 Month 22 Day
Last modified on	2018 Year 02 Month 23 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000021656