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Name:
UMIN ID:

Recruitment status No longer recruiting
Unique ID issued by UMIN UMIN000033396
Receipt No. 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

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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 Obsterics 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
Email 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
Email tachibana-y@ncchd.go.jp

Sponsor
Institute National Center for Child Health and Development
Institute
Department

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
Email

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
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000038076

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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