LoVE4MUM: Virtual Engagement for Preventing Postpartum Depression

NCT06366035 | Not Yet Recruiting

• 1 other identifier: NMRR ID-24-00924-HPO
• Study Type: interventional
• Target: 64
• Locations: 1 country
• Sites: 2

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.

Conditions

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

Keywords

Postpartum Depression; mHealth intervention; self-guided; postpartum mental health literacy

Outcome Measures

Primary Outcomes (1)

• Postpartum Depression

  Self report measure using the Edinburgh Postpartum Depression Scale (EPDS) by the subjects on their symptoms of emotional distress during pregnancy and the postnatal period. Scale has been validated in English and Malay language with a total of 10 items based on 4 point Likert scale (0-3). Expected scoring 0 - 30. Score above 12 is considered probable depression.

  Baseline, 1 week and 6 weeks postpartum

Secondary Outcomes (2)

• Postpartum Mental Health Literacy

  Baseline, 1 week and 6 weeks postpartum

• Automatic Negative Frequency

  Baseline, 1 week and 6 weeks postpartum

Study Arms (2)

Treatment as Usual (TAU)

NO INTERVENTION

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

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

Device: LoVE4MUM mobile application

Interventions

LoVE4MUM mobile application 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.

Treatment as Usual & LoVE4MUM phone application

Eligibility Criteria

• Age: 19 Years - 50 Years
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• National Institutes of Health, Ministry of Health Malaysia: lead

Study Sites (2)

Hospital Tengku Ampuan Rahimah

Klang, Selangor, 41586, Malaysia

Location

Hospital Shah Alam

Shah Alam, Selangor, 40000, Malaysia

Location

Related Publications (1)

• 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.

  PMID: 39869891 DERIVED

MeSH Terms

Conditions

Depression, Postpartum

Condition Hierarchy (Ancestors)

Puerperal Disorders; Pregnancy Complications; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Depressive Disorder; Mood Disorders; Mental Disorders

Study Officials

• Siti Sabrina Kamarudin, MBBS

  National Institute for Health, NIH Malaysia

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Siti Sabrina Kamarudin, MBBS

CONTACT

0355263000; saby721@gmail.com

Idayu Badilla Idris, PhD

CONTACT

603 - 9145 5887; idayubadilla.idris@ukm.edu.my

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: INVESTIGATOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Model Details: Single Blinded, Pilot Randomized Control Trial

Study Record Dates

• First Submitted: April 10, 2024
• First Posted: April 15, 2024
• Study Start: April 22, 2024
• Primary Completion: June 3, 2024
• Study Completion: October 1, 2024
• Last Updated: April 16, 2024

Record last verified: 2024-04

Data Sharing

• IPD Sharing: Will not share

Locations

MY (2)