UMIN-ICDS Clinical Trial

Public title

A Study to Prevent Perinatal Depression Using Online Peer Community

Acronym

A Study to Prevent Perinatal Depression Using Online Peer Community

Scientific Title

A Study to Prevent Perinatal Depression Using Online Peer Community

Scientific Title:Acronym

Mpeer community

Region

Japan

Condition

Depression

Classification by specialty

Psychiatry

Classification by malignancy

Others

Genomic information

NO

Narrative objectives1

Pregnant women with a certain level of depression or depression during pregnancy are very common, and the need for intervention is high, not only because of their own mental distress but also because of the impact on the growth and development of the fetus. In addition, pregnancy is a time when it is easier to secure time and motivation for disease prevention compared to the postpartum period, and pregnancy depression is a predictor of postpartum depression, so interventions during pregnancy can prevent postpartum depression as well.
There are several interventions for pregnancy depression, including Internet cognitive-behavioral therapy, but their effectiveness is limited, and new approaches are needed. Peer support, in which people with the same problems support each other, has already been used to a certain extent in the fields of cancer and mental illness, but the evidence is not yet sufficiently established. The need for online peer support is also increasing, but few platforms exist for such support.
Researchers' pilot study, which included a pre-post and historical control group comparison, yielded preliminary results suggesting an online community could potentially improve perinatal mother-to-infant bonding disorder and other related issues. However, the study also identified limitations, such as a low volume of communication within the online community.

Therefore, this study aims to mitigate perinatal depressive symptoms by implementing a novel online community designed to address these identified challenges.  If this study confirms that intervention via an online community is effective in reducing perinatal depressive symptoms, it is expected to contribute to the mental health of mothers in the future by fostering connections among expectant and new mothers online.

Basic objectives2

Efficacy

Basic objectives -Others

Trial characteristics_1

Trial characteristics_2

Developmental phase

Primary outcomes

EPDS (Edinburgh Postnatal Depression Scale)

Key secondary outcomes

The Mother-Infant Bonding Questionnaire: MIBQ, UCLA, LSNS, MHC-SF

Study type

Interventional

Basic design

Single arm

Randomization

Non-randomized

Randomization unit

Blinding

Open -no one is blinded

Control

Historical

Stratification

Dynamic allocation

Institution consideration

Blocking

Concealment

No. of arms

1

Purpose of intervention

Prevention

Type of intervention

Behavior,custom

Interventions/Control_1

The intervention used in the study is an online peer community provided by the Quon Corporation system.

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

Age-lower limit

18

years-old

<=

Age-upper limit

Not applicable

Gender

Female

Key inclusion criteria

Inclusion criteria of Study 1 will be (1) 18 years of age or older, (2) pregnant women who were expecting delivery at 12-20 weeks of gestation, and (3) had no history of depression at the time of recruitment.

Key exclusion criteria

Men (including self-identified men)

Target sample size

1000

Name of lead principal investigator

1st name	Daisuke
Middle name
Last name	Nishi

Organization

The University of Tokyo

Division name

Department of Mental Health, Graduate School of Medicine

Zip code

1130033

Address

7-3-1, Hongo, Bunkyoku

TEL

0358413612

Email

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

Name of contact person

1st name	Daisuke
Middle name
Last name	Nishi

Organization

The University of Tokyo

Division name

Department of Mental Health, Graduate School of Medicine

Zip code

113-0033

Address

7-3-1, Hongo, Bunkyoku

TEL

0358413612

Homepage URL

Email

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

Institute

The University of Tokyo

Institute

Department

Personal name

Daisuke Nishi

Organization

Ministry of Education

Organization

Division

Category of Funding Organization

Japanese Governmental office

Nationality of Funding Organization

Co-sponsor

Name of secondary funder(s)

Organization

The Research Ethics Review Board of Graduate School of Medicine/Faculty of Medicine, the University of Tokyo

Address

7-3-1, Hongo, Bunkyoku

Tel

03-5841-0818

Email

ethics@m.u-tokyo.ac.jp

Secondary IDs

NO

Study ID_1

Org. issuing International ID_1

Study ID_2

Org. issuing International ID_2

IND to MHLW

Institutions

Date of disclosure of the study information

2025

Year

11

Month

17

Day

URL releasing protocol

Publication of results

Unpublished

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

Recruitment status

Preinitiation

Date of protocol fixation

2025

Year

11

Month

07

Day

Date of IRB

2025

Year

11

Month

07

Day

Anticipated trial start date

2025

Year

11

Month

18

Day

Last follow-up date

2028

Year

03

Month

31

Day

Date of closure to data entry

Date trial data considered complete

Date analysis concluded

Other related information

Registered date

2025

Year

11

Month

15

Day

Last modified on

2025

Year

11

Month

12

Day

Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000067243