LoVE4MUM: Virtual Engagement for Preventing Postpartum Depression (LoVE4MUM)

April 14, 2024 updated by: Siti Sabrina binti Kamarudin, National Institutes of Health, Ministry of Health Malaysia

Leveraging on Virtual Engagement for Maternal Understanding & Mood-enhancement "LoVE4MUM" Mobile Application- A Protocol for Pilot Randomized Control Trial for Preventing Postpartum Depression

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.

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Estimated)

64

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

  • Name: Siti Sabrina Kamarudin, MBBS
  • Phone Number: 0355263000
  • Email: saby721@gmail.com

Study Contact Backup

Study Locations

  • Malaysia
    • Selangor
      • Klang, Selangor, Malaysia, 41586
        • Hospital Tengku Ampuan Rahimah
        • Contact:
          • Noor Fadzleeyanna Mohd Yahaya, MOG
          • Phone Number: 03-3375 7000
        • Principal Investigator:
          • Noor Fadzleeyanna Mohd Yahaya, MOG
        • Sub-Investigator:
          • Shalisah Sarip, PhD
        • Sub-Investigator:
          • Norfazilah Ahmad, PhD
      • Shah Alam, Selangor, Malaysia, 40000
        • Hospital Shah Alam
        • Contact:
        • Principal Investigator:
          • Siti Sabrina Kamarudin, MBBS
        • Sub-Investigator:
          • NNurul Syuhaida Abdul Razak, MOG
        • Sub-Investigator:
          • Idayu Badilla Idris, PhD

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult

Accepts Healthy Volunteers

Yes

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
No Intervention: 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
Experimental: 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
Device: 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Postpartum Depression
Time Frame: Baseline, 1 week and 6 weeks postpartum
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 Outcome Measures

Outcome Measure
Measure Description
Time Frame
Postpartum Mental Health Literacy
Time Frame: Baseline, 1 week and 6 weeks postpartum
self report measure using the Postpartum Depression Literacy Scale (PoDLiS) by the subjects on their knowledge and attitude on postpartum depression, help seeking, symptoms and available support. It has been validated in English and the Malay language. The 31 items is rated on a 5 point Likert scale (1-5). Total score is the total raw score divided by the total item. Higher score equivalents to higher postpartum mental health literacy
Baseline, 1 week and 6 weeks postpartum
Automatic Negative Frequency
Time Frame: Baseline, 1 week and 6 weeks postpartum
self report measure using the Automatic Thoughts Questionnaire (ATQ) by the subjects on the frequency of experiencing the negative thought statement. It has been validated in the English and Malay language. The 17 items is rated based on a 5 point Likert scale (1-5). Total score 17- 85. Higher score equivalent to higher frequency of negative thoughts.
Baseline, 1 week and 6 weeks postpartum

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

National Institutes of Health, Ministry of Health Malaysia

Investigators

  • Principal Investigator: Siti Sabrina Kamarudin, MBBS, National Institute for Health, NIH Malaysia

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

April 22, 2024

Primary Completion (Estimated)

June 3, 2024

Study Completion (Estimated)

October 1, 2024

Study Registration Dates

First Submitted

April 10, 2024

First Submitted That Met QC Criteria

April 10, 2024

First Posted (Actual)

April 15, 2024

Study Record Updates

Last Update Posted (Actual)

April 16, 2024

Last Update Submitted That Met QC Criteria

April 14, 2024

Last Verified

April 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • NMRR ID-24-00924-HPO

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

IPD Plan Description

information could be available upon reaching out to the principal investigator. However date relative to the time when summary data are published or otherwise made available starting 6 months after publication.

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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