LoVE4MUM: Virtual Engagement for Preventing Postpartum Depression

Mental Health Issue Clinical Trial

— LoVE4MUM  

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT06366035
• Other study ID #: NMRR ID-24-00924-HPO
• Status: Not yet recruiting
• Phase: N/A
• Start date: April 22, 2024
• Est. completion date: October 1, 2024

Study information

• Verified date: April 2024
• Source: National Institutes of Health, Ministry of Health Malaysia
• Contact: Siti Sabrina Kamarudin, MBBS
• Phone: 0355263000
• Email: saby721[@]gmail.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 64
• Est. completion date: October 1, 2024
• Est. primary completion date: June 3, 2024
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 19 Years to 50 Years

Eligibility

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

Related Conditions & MeSH terms

• Depression
• Depression, Postpartum
• Depressive Disorder
• Maternal Behavior
• Mental Health Issue
• mHealth Intervention
• Postpartum Depression

Intervention

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.

Locations

Country	Name	City	State
Malaysia	Hospital Tengku Ampuan Rahimah	Klang	Selangor
Malaysia	Hospital Shah Alam	Shah Alam	Selangor

Sponsors (1)

Lead Sponsor	Collaborator
National Institutes of Health, Ministry of Health Malaysia

Country where clinical trial is conducted

Malaysia, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Postpartum Mental Health Literacy	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
Secondary	Automatic Negative Frequency	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