UMIN-ICDS Clinical Trial

Public title

A Pilot Study to Prevent Perinatal Depression Using Online Peer Community and Metaverse Peer Support

Acronym

Mpeer Open

Scientific Title

A Pilot Study to Prevent Perinatal Depression Using Online Peer Community and Metaverse Peer Support

Scientific Title:Acronym

Mpeer Open

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 little platform exists for such support.
Therefore, this study aims to reduce depressive symptoms and prevent depression in late pregnancy and postpartum period by 1) universal prevention through online peer community and 2) prevention through digital peer support using the app and metaverse, targeting pregnant women. Both Study 1 and Study 2 will be pre-post comparative studies, and use a historical control group (Reference: Nishi et al. Psychiatry and Clinical Neurosciences 2022).

Basic objectives2

Efficacy

Basic objectives -Others

Trial characteristics_1

Trial characteristics_2

Developmental phase

Primary outcomes

EPDS (Edinburgh Postnatal Depression Scale)

Key secondary outcomes

K6, The Mother-Infant Bonding Questionnaire: MIBQ, UCLA, LSNS, MHC-SF, PBI

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 Study 1 is an online peer community provided by the Quon Corporation system.
The intervention used in Study 2 is digital peer support using the app and peer support meetings held in the metaverse space.

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

20

years-old

<=

Age-upper limit

Not applicable

Gender

Female

Key inclusion criteria

Inclusion criteria of Study 1 will be (1) 20 years of age or older, (2) pregnant women who were expecting delivery at 12-20 weeks gestation, and (3) had no history of depression in the past year.
Inclusion criteria of Study 2 will be study participants in Study 1 who agreed to participate in peer support using the app and peer support meetings held in the metaverse space by 24 weeks' gestation.

Key exclusion criteria

None

Target sample size

2000

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 Tokyko

Institute

Department

Personal name

Nishi

Organization

Ministry of Education

Organization

Division

Category of Funding Organization

Japanese Governmental office

Nationality of Funding Organization

Japan

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

2023

Year

11

Month

30

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

2023

Year

10

Month

30

Day

Date of IRB

2023

Year

11

Month

06

Day

Anticipated trial start date

2023

Year

12

Month

22

Day

Last follow-up date

2025

Year

03

Month

31

Day

Date of closure to data entry

Date trial data considered complete

Date analysis concluded

Other related information

Registered date

2023

Year

10

Month

01

Day

Last modified on

2023

Year

12

Month

19

Day

Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000059782