LoVE4MUM: Virtual Engagement for Preventing Postpartum Depression

NCT ID: NCT06366035

Last Updated: 2024-04-16

Basic Information

• Recruitment Status: NOT_YET_RECRUITING
• Clinical Phase: NA
• Total Enrollment: 64 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2024-04-22
• Study Completion Date: 2024-10-01

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.

Conditions

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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: PREVENTION
• Blinding Strategy: SINGLE

Study Groups

Treatment as Usual (TAU)

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

Group Type: NO_INTERVENTION

No interventions assigned to this group

Treatment as Usual & LoVE4MUM phone application

Mothers receiving treatment as usual (TAU) and LoVE4MUM phone application from period of delivery up to 6 weeks postpartum

Group Type: EXPERIMENTAL

LoVE4MUM mobile application

Intervention Type: DEVICE

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.

Interventions

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.

Intervention Type: DEVICE

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

• Minimum Eligible Age: 19 Years
• Maximum Eligible Age: 50 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: Yes

Sponsors

National Institutes of Health, Ministry of Health Malaysia

OTHER

Sponsor Role: lead

Responsible Party

Siti Sabrina binti Kamarudin

Principal Investigator

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Siti Sabrina Kamarudin, MBBS

Role: PRINCIPAL_INVESTIGATOR

National Institute for Health, NIH Malaysia

Locations

Hospital Tengku Ampuan Rahimah

Klang, Selangor, Malaysia

Hospital Shah Alam

Shah Alam, Selangor, Malaysia

Countries

Malaysia

Central Contacts

Siti Sabrina Kamarudin, MBBS

Role: CONTACT

saby721@gmail.com

0355263000

Idayu Badilla Idris, PhD

Role: CONTACT

idayubadilla.idris@ukm.edu.my

603 - 9145 5887

Facility Contacts

Noor Fadzleeyanna Mohd Yahaya, MOG

Role: primary

03-3375 7000

Siti Sabrina Kamarudin

Role: primary

saby721@gmail.com

0355263000 ext. 3305

References

Kamarudin SS, Idris IB, Sharip S, Ahmad N. LoVE4MUM Mobile App to Prevent Postpartum Depression: Protocol for a Pilot Randomized Controlled Trial. JMIR Res Protoc. 2025 Jan 27;14:e63564. doi: 10.2196/63564.

Reference Type: DERIVED

PMID: 39869891 (View on PubMed)

Other Identifiers

NMRR ID-24-00924-HPO

Identifier Type: -

Identifier Source: org_study_id