LoVE4MUM: Virtual Engagement for Preventing Postpartum Depression

Status Not yet recruiting

Clinical Trial 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.

Clinical Trial 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. ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details

NCT number	NCT06366035
Study type	Interventional
Source	National Institutes of Health, Ministry of Health Malaysia
Contact	Siti Sabrina Kamarudin, MBBS
Phone	0355263000
Email	saby721@gmail.com
Status	Not yet recruiting
Phase	N/A
Start date	April 22, 2024
Completion date	October 1, 2024

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Clinical trials are conducted in a series of steps, called phases - each phase is designed to answer a separate research question.

Phase 1: Researchers test a new drug or treatment in a small group of people for the first time to evaluate its safety, determine a safe dosage range, and identify side effects.
Phase 2: The drug or treatment is given to a larger group of people to see if it is effective and to further evaluate its safety.
Phase 3: The drug or treatment is given to large groups of people to confirm its effectiveness, monitor side effects, compare it to commonly used treatments, and collect information that will allow the drug or treatment to be used safely.
Phase 4: Studies are done after the drug or treatment has been marketed to gather information on the drug's effect in various populations and any side effects associated with long-term use.

LoVE4MUM: Virtual Engagement for Preventing Postpartum Depression — LoVE4MUM

Clinical Trial Summary

Clinical Trial Description

Study Design

Related Conditions & MeSH terms