UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000020133 |
|---|---|
| Receipt number | R000023258 |
| Scientific Title | Application of Mental Health First Aid to medical staff: Multicenter pilot study |
| Date of disclosure of the study information | 2015/12/10 |
| Last modified on | 2024/02/26 15:14:01 |
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Basic information
Public title
Application of Mental Health
First Aid to medical staff: Multicenter pilot study
Acronym
Application of Mental Health
First Aid to medical staff
Scientific Title
Application of Mental Health
First Aid to medical staff: Multicenter pilot study
Scientific Title:Acronym
Application of Mental Health
First Aid to medical staff
Region
| Japan |
Condition
Condition
Depression and suicide related behaviors
Classification by specialty
| Psychiatry |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To evaluate the effectiveness of a brief structured training program based on Mental Health First Aid to increase knowledge and skills for medical staff, institutional staff and employees (including managers) to deal with person with depression and suicidal thoughts.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Confirmatory
Trial characteristics_2
Pragmatic
Developmental phase
Not applicable
Assessment
Primary outcomes
The change of score of questionnaire asking knowledge, skills and confidence to deal with person with depression and suicidal thoughts at just before, just after and one month later the intervention
Key secondary outcomes
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 playing
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
Medical staff, welfare service worker, non-medical staff such as student counseling center, company, students majoring in medicine, dentistry, pharmacy, or science of jnursing, and so on, given written informed consents on this study
Key exclusion criteria
None
Target sample size
350
Research contact person
Name of lead principal investigator
| 1st name | Takahiro |
| Middle name | A |
| Last name | Kato |
Organization
Kyushu University
Division name
Department of Neuropsychiatry Graduate School of Medical Sciences
Zip code
812-8582
Address
3-1-1, Maidashi, Higashi-ku, Fukuoka-shi, Fukuoka 812-8582, Japan
TEL
092-642-5627
kato.takahiro.015@m.kyushu-u.ac.jp
Public contact
Name of contact person
| 1st name | Takahiro |
| Middle name | A |
| Last name | Kato |
Organization
Kyushu University
Division name
Department of Neuropsychiatry Graduate School of Medical Sciences
Zip code
812-8582
Address
3-1-1, Maidashi, Higashi-ku, Fukuoka-shi, Fukuoka 812-8582, Japan
TEL
092-642-5627
Homepage URL
kato.takahiro.015@m.kyushu-u.ac.jp
Sponsor or person
Institute
Kyushu University
Institute
Department
Personal name
Funding Source
Organization
Grant for clinical cancer research from
the Ministry of Health, Labour and
Welfare, Japan (Japan Agency for Medical Research and Development: AMED)
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 Hospital IRB
Address
3-1-1, Maidashi, Higashi-ku, Fukuoka-shi, Fukuoka 812-8582, Japan
Tel
092-642-5082
byssien@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
九州大学病院（福岡県）、岩手医科大学附属病院（岩手県）、慶応義塾大学病院（東京都）、北海道大学病院（北海道）、北海道大学保健センター（北海道）、横浜市立大学附属病院（神奈川県）、北九州市精神保健福祉センター（福岡県）、京都大学医学部附属病院（京都府）、飯塚病院（福岡県）、帝京大学（東京都）、東京薬科大学（東京都）、城西国際大学（千葉県）、非医療機関（企業等）
Other administrative information
Date of disclosure of the study information
| 2015 | Year | 12 | Month | 10 | 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
| 2015 | Year | 09 | Month | 01 | Day |
Date of IRB
| 2019 | Year | 03 | Month | 18 | Day |
Anticipated trial start date
| 2015 | Year | 12 | Month | 18 | Day |
Last follow-up date
| 2026 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
COVID-19 has made it difficult to recruit research participants and has caused delays in this research.
Management information
Registered date
| 2015 | Year | 12 | Month | 09 | Day |
Last modified on
| 2024 | Year | 02 | Month | 26 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000023258
