NCT06366035

LoVE4MUM: Virtual Engagement for Preventing Postpartum Depression

Leveraging on Virtual Engagement for Maternal Understanding & Mood-enhancement "LoVE4MUM" Mobile Application- A Protocol for Pilot Randomized Control Trial for Preventing Postpartum Depression

• Status: Not Yet Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 64 (estimated)
• Sponsor: National Institutes of Health, Ministry of Health Malaysia · Academic / Other
• Sex: Female
• Age: 19 Years – 50 Years
• Healthy volunteers: Accepted

Summary

Postpartum depression is a serious concern affecting mothers and their infants, especially with limited traditional support. This pilot study evaluates the effectiveness of a novel mobile app called LoVE4MUM, developed based on Cognitive Behavioral Therapy and Psychoeducation principles, in preventing postpartum depression. The pilot trial involves 64 mothers randomly assigned to receive either standard care or standard care plus the LoVE4MUM. Primary outcome is improvement in depression, with secondary outcomes including mental health literacy and automatic negative thoughts. This research aims to provide initial evidence on the potential of mobile health tools to support maternal mental health, paving the way for future accessible and effective interventions.

Detailed description

Postpartum depression (PPD) is a significant mental health issue. Traditional support systems remains challenging and mHealth intervention provides an opportunity to access for support. The primary objective of this study is to preliminarily assess the effectiveness of a developed mobile application called LoVE4MUM in prevention of postpartum depression. The study will employ a single-blinded, pilot randomized controlled trial (RCT) design involving a sample of 64 mothers. Participants will be randomly assigned in a 1:1 ratio to one of two groups: the intervention group, which will receive standard postpartum care plus LoVE4MUM mobile application, or the control group, which will receive standard postpartum care alone. The primary outcome measure will be the effectiveness of the mobile application in improving symptoms of postpartum depression among mothers. Secondary outcome measures will include changes in postpartum mental health literacy scores and negative automatic thoughts frequencies. Through the systematic evaluation of the LoVE4MUM mobile application in conjunction with standard postpartum care, this pilot RCT aims to generate preliminary evidence regarding the efficacy and feasibility of using mHealth tools for preventing postpartum depression.

Conditions

• Postpartum Depression
• Maternal Behavior
• mHealth Intervention
• Mental Health Issue

Interventions

Type	Name	Description
DEVICE	LoVE4MUM mobile application	LoVE4MUM is an innovative mobile application developed based on cognitive behavioral therapy and psychoeducation. The mobile application consist of 5 main modules which delivers information pertaining self-care, postpartum depression, handling negative thoughts, mood tracking and information for seeking help. The module consist of short notes, videos and worksheets for the participants to conduct.

Timeline

• Start date: 2024-04-22
• Primary completion: 2024-06-03
• Completion: 2024-10-01
• First posted: 2024-04-15
• Last updated: 2024-04-16

Locations

2 sites across 1 country: Malaysia