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LoVE4MUM Mobile App to Prevent Postpartum Depression: Protocol for a Pilot Randomized Controlled Trial
Siti Sabrina Kamarudin1,2, Idayu Badilla Idris2, Shalisah Sharip3
1Clinical Research Center Hospital Shah Alam, Institute for Clinical Research, National Institute for Health, Ministry of Health Malaysia, Shah Alam, Malaysia.
Background:
Postpartum depression remains a significant concern, posing substantial challenges to maternal well-being, infant health, and the mother-infant bond, particularly in the face of barriers to traditional support and interventions. Previous studies have shown that mobile health (mHealth) interventions offer an accessible means to facilitate early detection and management of mental health issues while at the same time promoting preventive care.
Objective:
This study aims to evaluate the effectiveness of the Leveraging on Virtual Engagement for Maternal Understanding & Mood-enhancement (LoVE4MUM) mobile app, which was developed based on the principles of cognitive behavioral therapy and psychoeducation and serves as an intervention to prevent postpartum depression.
Methods:
This single-blinded, pilot randomized controlled trial includes 64 mothers recruited from the postnatal ward and randomized using a 1:1 ratio to receive either postpartum care (treatment as usual) or postpartum care (treatment as usual) plus the self-guided LoVE4MUM mobile app. The primary outcome is the effectiveness of the mobile app at improving postpartum depression. Secondary outcomes are changes in the mental health literacy score and negative automatic thoughts, which are collected using a self-reported questionnaire.
Results:
Patient recruitment began on September 1, 2024. As of January 1, 2025, recruitment was successfully completed, with a total of 72 participants enrolled: 36 in the intervention group and 36 in the control group . The final results are anticipated to be available by March 2025, and publication is expected by the end of 2025.
Conclusions:
By examining the LoVE4MUM app alongside standard postpartum care, this pilot randomized controlled trial seeks to offer preliminary evidence on the potential of mHealth tools to improve maternal mental health as well as to reduce postpartum depression symptoms. The findings are expected to contribute to the future development of effective, accessible, and scalable interventions for mothers.
Trial Registration:
ClinicalTrials.gov NCT06366035; https://clinicaltrials.gov/study/NCT06366035.
International Registered Report Identifier (Irrid):
PRR1-10.2196/63564.
