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LoVE4MUM: Virtual Engagement for Preventing Postpartum Depression

N

National Institutes of Health, Ministry of Health Malaysia

Status

Not yet enrolling

Conditions

Mental Health Issue
mHealth Intervention
Maternal Behavior
Postpartum Depression

Treatments

Device: LoVE4MUM mobile application

Study type

Interventional

Funder types

Other

Identifiers

NCT06366035
NMRR ID-24-00924-HPO

Details and patient eligibility

About

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.

Full 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.

Enrollment

64 estimated patients

Sex

Female

Ages

19 to 50 years old

Volunteers

Accepts Healthy Volunteers

Inclusion criteria

  • mothers with EPDS score 9-<12
  • mothers with access to smartphone and internet connectivity
  • continue routine postpartum care at the government health facilities
  • literate in english and malay

Exclusion criteria

  • history of drug abuse
  • diagnosis of depressive illness or any other mental health illness
  • undergoing treatment for mental health
  • infant born with intrauterine death or died immediately after birth

Trial design

Primary purpose

Prevention

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Single Blind

64 participants in 2 patient groups

Treatment as Usual (TAU)
No Intervention group
Description:
Mothers receiving treatment as usual (TAU) at the postpartum health care facilities according to standard guideline from period of delivery up to 6 weeks postpartum
Treatment as Usual & LoVE4MUM phone application
Experimental group
Description:
Mothers receiving treatment as usual (TAU) and LoVE4MUM phone application from period of delivery up to 6 weeks postpartum
Treatment:
Device: LoVE4MUM mobile application

Trial contacts and locations

2

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Central trial contact

Siti Sabrina Kamarudin, MBBS; Idayu Badilla Idris, PhD

Data sourced from clinicaltrials.gov

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