UMIN-CTR Clinical Trial

Basic information
Public title	Effects of mental health literacy program for school teacher on stigma toward mental illness
Acronym	Effects of mental health literacy program for school teacher
Scientific Title	Effects of mental health literacy program for school teacher on stigma toward mental illness
Scientific Title:Acronym	Effects of mental health literacy program for school teacher
Region	Japan

Condition
Condition	school teacher
Classification by specialty	Psychiatry
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	Mental Health Literacy Education (MHL Education) is thought to be important in prevention of mental illness, early detection and early treatment, and reduction of stigma toward mental disorders. Prior to implementing appropriate MHL education for students, we examine the influence of MHL education program for school teachers on stigma.
Basic objectives2	Efficacy
Basic objectives -Others
Trial characteristics_1	Exploratory
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	self-completed questionnaire before and after the intervention
Key secondary outcomes	Japanese version of the Reported and Intended Behaviour Scale before and after the intervention

Base
Study type	Interventional

Study design
Basic design	Parallel
Randomization	Randomized
Randomization unit	Individual
Blinding	Open -no one is blinded
Control	No treatment
Stratification	YES
Dynamic allocation
Institution consideration
Blocking	YES
Concealment

Intervention
No. of arms	2
Purpose of intervention	Prevention
Type of intervention	Behavior,custom
Interventions/Control_1	Participants in the intervention group are watched DVD about mental health literacy for about 50 minutes.
Interventions/Control_2	Participant in the control group wait until the end of the watching DVD of the intervention group.
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	65 years-old >=
Gender	Male and Female
Key inclusion criteria	school teacher
Key exclusion criteria	None
Target sample size	80

Research contact person
Name of lead principal investigator	1st name Yasuhiro Middle name Last name Matsuda
Organization	Nara Medical University School of Medicine
Division name	department of Psychiatry
Zip code	6348522
Address	840 Shijo-cho, Kashihara, Nara
TEL	0744-22-3051
Email	yasumatsuda319@hotmail.com

Public contact
Name of contact person	1st name Yasuhiro Middle name Last name Matsuda
Organization	Nara Medical University School of Medicine
Division name	department of Psychiatry
Zip code	6348522
Address	840 Shijo-cho, Kashihara, Nara
TEL	0744-22-3051
Homepage URL
Email	yasumatsuda319@hotmail.com

Sponsor
Institute	Nara Medical University School of Medicine
Institute
Department

Funding Source
Organization	None
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	Nara Medical University School of Medicine
Address	840 Shijo-cho, Kashihara, Nara
Tel	0744-22-3051
Email	smuraka@naramed-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	奈良県立医科大学

Other administrative information
Date of disclosure of the study information	2018 Year 04 Month 19 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	Open public recruiting
Date of protocol fixation	2018 Year 04 Month 19 Day
Date of IRB	2018 Year 04 Month 20 Day
Anticipated trial start date	2018 Year 04 Month 20 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	2018 Year 04 Month 19 Day
Last modified on	2019 Year 08 Month 15 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000035535