Tokyo, Nov. 17 -- UMIN Clinical Trials Registry (UMIN-CTR) received information related to the study (UMIN000059788) titled 'A Study to Prevent Perinatal Depression Using Online Peer Community' on Nov. 17.
Study Type:
Interventional
Study Design:
Basic Design - Single arm
Randomization - Non-randomized
Blinding - Open -no one is blinded
Control - Historical
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.
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
Intervention:
Interventions/Control_1 - The intervention used in the study is an online peer community provided by the Quon Corporation system.
Eligibility:
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 Size - 1000
Recruitment Status:
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
To know more, visit https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000067243
Disclaimer: Curated by HT Syndication.