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

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 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


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

Value
https://center6.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