UMIN-ICDS Clinical Trial
| Unique ID issued by UMIN | UMIN000063335 |
|---|---|
| Receipt number | R000070524 |
| Scientific Title | Development of a Gatekeeper Training Program for Midwives to Facilitate the Early Recognition of Perinatal Depression |
| Date of disclosure of the study information | 2026/10/19 |
| Last modified on | 2026/10/19 11:07:47 |
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Basic information
Public title
Development of a Gatekeeper Training Program for Midwives to Facilitate the Early Recognition of Perinatal Depression
Acronym
Development of a Gatekeeper Training Program for Midwives
Scientific Title
Development of a Gatekeeper Training Program for Midwives to Facilitate the Early Recognition of Perinatal Depression
Scientific Title:Acronym
Development of a Gatekeeper Training Program for Midwives
Region
| Japan |
Condition
Condition
Depression
Classification by specialty
| Psychiatry |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
While mental disorders are implicated in 90% of suicide-related behaviors (ACTION-J, Kawanishi et al., 2014), a report from Tokyo (Takeda, 2016) found that 61% of pregnant women and 39% of postpartum women who died by suicide had a diagnosis of "Not available" indicating that perinatal mental health issues are not being adequately detected prior to death.
Basic objectives2
Others
Basic objectives -Others
While many studies on the detection of perinatal mental health distress rely primarily on questionnaires, research and evidence regarding early detection, intervention, and suicide prevention remain limited worldwide. The aim of this study is to develop an effective gatekeeper training program for midwives to facilitate the early detection and intervention of perinatal mental health distress and to support suicide prevention practices.
Trial characteristics_1
Others
Trial characteristics_2
Others
Developmental phase
Not applicable
Assessment
Primary outcomes
Gatekeeper Self-Efficacy Scale (GKSES) (Morita, 2015) scores before and after the training
Key secondary outcomes
(1) Attitude toward Suicide (ATTS) scores (Renberg & Jacobsson, 2003) before and after the training
(2) Analysis of participant characteristics: age, work history, past training history, and experience in caring for pregnant women and postpartum women with mental disorders
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
Attendance at the training session
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
| 22 | years-old | <= |
Age-upper limit
| 100 | years-old | > |
Gender
Female
Key inclusion criteria
Midwives participating in this study
Key exclusion criteria
Midwives who did not consent to this study
Target sample size
200
Research contact person
Name of lead principal investigator
| 1st name | Tomonori |
| Middle name | |
| Last name | Kashiwagi |
Organization
Sapporo Medical University Graduate School of Medicine
Division name
Department of Neuropsychiatry
Zip code
0608543
Address
Minami 1-jo Nishi 17, Chuo-ku, Sapporo, Hokkaido, Japan
TEL
0116112111
t.kashiwa19860602@gmail.com
Public contact
Name of contact person
| 1st name | Tomonori |
| Middle name | |
| Last name | Kashiwagi |
Organization
Sapporo Medical University Graduate School of Medicine
Division name
Department of Neuropsychiatry
Zip code
0608543
Address
Minami 1-jo Nishi 17, Chuo-ku, Sapporo, Hokkaido, Japan
TEL
0116112111
Homepage URL
t.kashiwa19860602@gmail.com
Sponsor or person
Institute
Sapporo Medical University Graduate School of Medicine, Department of Neuropsychiatry, Tomonori Kashiwagi
Institute
Department
Personal name
Funding Source
Organization
Japan Science and Technology Agency
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
Sapporo Medical University Hospital
Address
291 Minami 1-jo Nishi 16, Chuo-ku, Sapporo, Hokkaido, Japan
Tel
0116112111
t.kashiwa19860602@gmail.com
Secondary IDs
Secondary IDs
NO
Study ID_1
Org. issuing International ID_1
Study ID_2
Org. issuing International ID_2
IND to MHLW
北海道
Institutions
Institutions
Other administrative information
Date of disclosure of the study information
| 2026 | Year | 10 | 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
| 2024 | Year | 06 | Month | 18 | Day |
Date of IRB
| 2024 | Year | 06 | Month | 28 | Day |
Anticipated trial start date
| 2024 | Year | 10 | Month | 01 | Day |
Last follow-up date
| 2026 | Year | 12 | 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
| 2026 | Year | 10 | Month | 19 | Day |
Last modified on
| 2026 | Year | 10 | Month | 19 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000070524
