UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000033396 |
|---|---|
| Receipt number | R000038076 |
| Scientific Title | A multidisciplinary intervention program for maternal mental health in perinatal periods |
| Date of disclosure of the study information | 2018/07/15 |
| Last modified on | 2018/07/15 14:49:27 |
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Basic information
Public title
A multidisciplinary intervention program for maternal mental health in perinatal periods
Acronym
Nagano trial
Scientific Title
A multidisciplinary intervention program for maternal mental health in perinatal periods
Scientific Title:Acronym
Nagano trial
Region
| Japan |
Condition
Condition
Mental health problems in perinatal periods
Classification by specialty
| Psychosomatic Internal Medicine | Obstetrics and Gynecology | Psychiatry |
| Nursing | Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
We develop an intervention program of comprehensive perinatal mental cares. We hypothesize the intervention program could reduce postnatal suicide ideation and improve maternal mental health.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
The item 10 of the Edinburgh Postnatal Depression Scale at three to four months postnatal
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
Historical
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
1
Purpose of intervention
Treatment
Type of intervention
| Other |
Interventions/Control_1
Firstly, all the postnatal women will received mental a health screening with the EPDS by the public health nurses who did home visit in the neonatal periods. Secondly, the intervention program will be performed by a multidisciplinary clinical network. Thirdly, the public health nurses will also use the follow-up sheets for the support of women at risk of psychosocial problems.
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
Female
Key inclusion criteria
The inclusion criterion is all women who turned in the birth notification to Nagano city office.
Key exclusion criteria
There is no exclusion criterion for this study.
Target sample size
400
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Yoshiyuki Tachibana |
Organization
National Center for Child Health and Development
Division name
Division of Infant and Toddler Mental Health, Department of Psychosocial Medicine
Zip code
Address
2-10-1 Okura, Setagaya-ku, Tokyo, Japan 157-8535
TEL
0334160181
tachibana-y@ncchd.go.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Yoshiyuki Tachibana |
Organization
National Center for Child Health and Development
Division name
Division of Infant and Toddler Mental Health, Department of Psychosocial Medicine
Zip code
Address
2-10-1 Okura, Setagaya-ku, Tokyo, Japan 157-8535
TEL
03-3416-0181
Homepage URL
tachibana-y@ncchd.go.jp
Sponsor or person
Institute
National Center for Child Health and Development
Institute
Department
Personal name
Funding Source
Organization
This study has been supported the grants by Japanese Ministry of Health, Labour and Welfare and Japan Agency for Medical Research and Development.
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
Address
Tel
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
| 2018 | Year | 07 | Month | 15 | 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
No longer recruiting
Date of protocol fixation
| 2015 | Year | 06 | Month | 01 | Day |
Date of IRB
Anticipated trial start date
| 2015 | Year | 11 | Month | 01 | Day |
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2018 | Year | 07 | Month | 15 | Day |
Last modified on
| 2018 | Year | 07 | Month | 15 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000038076
