Clinical trial NCT06366035: LoVE4MUM: Virtual Engagement for Preventing Postpartum Depression
Official title: Leveraging on Virtual Engagement for Maternal Understanding & Mood-enhancement "LoVE4MUM" Mobile Application- A Protocol for Pilot Randomized Control Trial for Preventing Postpartum Depression
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Postpartum Depression
Maternal Behavior
mHealth Intervention
Mental Health Issue
Keywords: Postpartum Depression
mHealth intervention
self-guided
postpartum mental health literacy
Lead sponsor: National Institutes of Health, Ministry of Health Malaysia
Sponsor class: OTHER
First posted: 2024-04-15
Enrollment: 64
Sex: FEMALE
Minimum age (years): 19
Maximum age (years): 50
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Single Blinded, Pilot Randomized Control Trial
Primary purpose: PREVENTION

Brief 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.

Eligibility criteria: 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

Primary outcomes:
measure: Postpartum Depression
timeFrame: Baseline, 1 week and 6 weeks postpartum
Secondary outcomes:
measure: Postpartum Mental Health Literacy
timeFrame: Baseline, 1 week and 6 weeks postpartum
measure: Automatic Negative Frequency
timeFrame: Baseline, 1 week and 6 weeks postpartum
Other outcomes:
Locations:
city: Klang
country: Malaysia
facility: Hospital Tengku Ampuan Rahimah
state: Selangor
city: Shah Alam
country: Malaysia
facility: Hospital Shah Alam
state: Selangor
Study officials:
affiliation: National Institute for Health, NIH Malaysia
name: Siti Sabrina Kamarudin, MBBS
role: PRINCIPAL_INVESTIGATOR
References: