UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000058381
Receipt number R000066686
Scientific Title Barriers and facilitators to implementation of midwife-involved perinatal mental health support: A systematic review using Consolidated Framework for Implementation Research (CFIR)
Date of disclosure of the study information 2025/07/11
Last modified on 2025/07/07 09:45:01

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Basic information

Public title

Barriers and facilitators to implementation of midwife-involved perinatal mental health support: A systematic review using Consolidated Framework for Implementation Research (CFIR)

Acronym

Barriers and facilitators to midwife-involved perinatal mental health support

Scientific Title

Barriers and facilitators to implementation of midwife-involved perinatal mental health support: A systematic review using Consolidated Framework for Implementation Research (CFIR)

Scientific Title:Acronym

Barriers and facilitators to midwife-involved perinatal mental health support

Region

Japan Asia(except Japan) North America
South America Australia Europe
Africa


Condition

Condition

Perinatal depression, perinatal anxiety, perinatal stress, psychiatric disorders

Classification by specialty

Obstetrics and Gynecology Psychiatry

Classification by malignancy

Others

Genomic information

NO


Objectives

Narrative objectives1

To systematically extract implementation facilitators and barriers from existing empirical studies on midwife-involved perinatal mental health support, and classify them using the Consolidated Framework for Implementation Research (CFIR), and to generate foundational knowledge for the development of future implementation strategies.

Basic objectives2

Others

Basic objectives -Others

Implementation Science

Trial characteristics_1


Trial characteristics_2


Developmental phase



Assessment

Primary outcomes

Facilitators, barriers, acceptability, feasibility, and midwives' experiences, perceptions, and attitudes regarding the implementation of midwife-involved perinatal mental health support.

Key secondary outcomes



Base

Study type

Others,meta-analysis etc


Study design

Basic design


Randomization


Randomization unit


Blinding


Control


Stratification


Dynamic allocation


Institution consideration


Blocking


Concealment



Intervention

No. of arms


Purpose of intervention


Type of intervention


Interventions/Control_1


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

- Studies involving women in the perinatal period (pregnancy through the first year postpartum)
- Studies in which midwives are explicitly involved in perinatal mental health support through leading, co-delivering, or supportive roles.
*Midwives are defined according to national or organizational standards as midwives or midwifery care providers.
- Studies reporting on facilitators, barriers, acceptability, feasibility, and midwives' experiences, perceptions, and attitudes regarding the implementation of midwife-involved perinatal mental health support.
- All empirical study designs.
- Studies conducted in any country or region.
- Studies written in English or Japanese.
- Peer-reviewed or grey literature with clearly identifiable sources.

Key exclusion criteria

- Protocol papers
- Review articles
- Editorials, commentaries, or opinion pieces without original data
- Publications without accessible full text

Target sample size



Research contact person

Name of lead principal investigator

1st name Daisuke
Middle name
Last name Nishi

Organization

Graduate School of Medicine, The University of Tokyo

Division name

Department of Mental Health

Zip code

110-0033

Address

7-3-1 Hongo, Bunkyo-ku, Tokyo 113-0033, JAPAN

TEL

+81-3-5841-3612

Email

d-nishi@m.u-tokyo.ac.jp


Public contact

Name of contact person

1st name Rino
Middle name
Last name Nishida

Organization

Graduate School of Medicine, The University of Tokyo

Division name

Department of Mental Health

Zip code

113-0033

Address

7-3-1 Hongo, Bunkyo-ku, Tokyo 113-0033, JAPAN

TEL

+81-3-5841-3364

Homepage URL


Email

prino.666@gmail.com


Sponsor or person

Institute

Department of Mental Health
Graduate School of Medicine, The University of Tokyo

Institute

Department

Personal name



Funding Source

Organization

Japan Science and Technology Agency
JST SPRING, Grant Number JPMJSP2108

Organization

Division

Category of Funding Organization

Other

Nationality of Funding Organization

JAPAN


Other related organizations

Co-sponsor


Name of secondary funder(s)



IRB Contact (For public release)

Organization

Department of Mental Health, Graduate School of Medicine, The University of Tokyo

Address

7-3-1 Hongo, Bunkyo-ku, Tokyo 113-0033, JAPAN

Tel

+81-3-5841-3612

Email

d-nishi@m.u-tokyo.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



Other administrative information

Date of disclosure of the study information

2025 Year 07 Month 11 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

Preinitiation

Date of protocol fixation

2025 Year 07 Month 16 Day

Date of IRB


Anticipated trial start date

2025 Year 07 Month 16 Day

Last follow-up date

2025 Year 12 Month 31 Day

Date of closure to data entry


Date trial data considered complete


Date analysis concluded



Other

Other related information

A systematic review to identify facilitators and barriers to the implementation of perinatal mental health support involving midwives.


Management information

Registered date

2025 Year 07 Month 07 Day

Last modified on

2025 Year 07 Month 07 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000066686