UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000058880 |
|---|---|
| Receipt number | R000067242 |
| Scientific Title | A Study to Prevent Perinatal Depression Using Metaverse Peer Support |
| Date of disclosure of the study information | 2025/08/25 |
| Last modified on | 2025/08/24 07:48:04 |
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Basic information
Public title
A Study to Prevent Perinatal Depression Using Metaverse Peer Support
Acronym
A Study to Prevent Perinatal Depression Using Metaverse Peer Support
Scientific Title
A Study to Prevent Perinatal Depression Using Metaverse Peer Support
Scientific Title:Acronym
Mpeer RCT
Region
| Japan |
Condition
Condition
Depression
Classification by specialty
| Psychiatry |
Classification by malignancy
Others
Genomic information
NO
Objectives
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.
The researchers conducted a pilot study with a pre-post design, obtaining preliminary results that suggested the possibility of mitigating depressive symptoms in pregnant women with a certain level of baseline perinatal depression through metaverse-based peer support. Therefore, this study aims to investigate the effect of metaverse-based peer support on reducing perinatal depressive symptoms through a randomized controlled trial study. If this study reveals that a platform for peer support among pregnant women is effective in mitigating depressive symptoms, it is expected to contribute to the mental health of mothers in the future by promoting the widespread use of such platforms.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
EPDS (Edinburgh Postnatal Depression Scale)
Key secondary outcomes
The Mother-Infant Bonding Questionnaire: MIBQ, UCLA, LSNS, MHC-SF, QMI
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Open -no one is blinded
Control
No treatment
Stratification
YES
Dynamic allocation
NO
Institution consideration
Blocking
Concealment
Intervention
No. of arms
2
Purpose of intervention
Prevention
Type of intervention
| Behavior,custom |
Interventions/Control_1
The intervention used in the study is digital peer support using the app and peer support meetings held in the metaverse space.
Interventions/Control_2
For the control group, general medical information about depression and health information for pregnant and postpartum women issued by public institutions such as the Ministry of Health, Labour and Welfare will be provided.
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
| 18 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Female
Key inclusion criteria
Inclusion criteria will be as follows: (1) age 18 years or older; (2) pregnant women less than 28 weeks of gestation who plan to give birth; (3) a score of 5 or higher on the Kessler Psychological Distress Scale (K6), a screening tool for psychological distress; (4) not receiving treatment for any mental disorder at the time of study enrollment; and (5) women.
Key exclusion criteria
None
Target sample size
210
Research contact person
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
d-nishi@m.u-tokyo.ac.jp
Public contact
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
d-nishi@m.u-tokyo.ac.jp
Sponsor or person
Institute
The University of Tokyo
Institute
Department
Personal name
Daosile Nishi
Funding Source
Organization
Ministry of Education
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
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
ethics@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 | 08 | Month | 25 | 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 | 08 | Month | 07 | Day |
Date of IRB
Anticipated trial start date
| 2025 | Year | 08 | Month | 26 | Day |
Last follow-up date
| 2028 | Year | 09 | Month | 30 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2025 | Year | 08 | Month | 25 | Day |
Last modified on
| 2025 | Year | 08 | Month | 24 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000067242
