Tokyo, Aug. 25 -- UMIN Clinical Trials Registry (UMIN-CTR) received information related to the study (UMIN000058880) titled 'A Study to Prevent Perinatal Depression Using Metaverse Peer Support' on Aug. 25.

Study Type: Interventional

Study Design: Basic Design - Parallel Randomization - Randomized Blinding - Open -no one is blinded Control - No treatment

Primary Sponsor: Institute - The University of Tokyo

Condition: Condition - Depression Classification by malignancy - Others Genomic information - NO

Objective: 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

Intervention: 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.

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 Size - 210

Recruitment Status: Recruitment status - Preinitiation Date of protocol fixation - 2025 Year 08 Month 07 Day Anticipated trial start date - 2025 Year 08 Month 26 Day Last follow-up date - 2028 Year 09 Month 30 Day

To know more, visit https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000067242

Disclaimer: Curated by HT Syndication.