An interventional study of LoVE4MUM mobile application in Postpartum Depression, Maternal Behavior and mHealth Intervention, sponsored by National Institutes of Health, Ministry of Health Malaysia. Not yet recruiting at 2 sites in Malaysia. Open to female participants aged 19 Years to 50 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2024-04-16.
Sponsored by National Institutes of Health, Ministry of Health Malaysia · Not applicable, Interventional, and Prevention
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.
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.
528 studies on the registry are indexed under Depression, Postpartum; 124 are open to participants now.
This study's planned enrollment of 64 is below the median of 105 across 425 interventional studies indexed under Depression, Postpartum.
Browse Depression, Postpartum studies →This is the only study on the registry with National Institutes of Health, Ministry of Health Malaysia as lead sponsor.
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Exclusion Criteria:
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
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.
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.
Time frame: Baseline, 1 week and 6 weeks postpartum
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
Time frame: Baseline, 1 week and 6 weeks postpartum
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.
Time frame: Baseline, 1 week and 6 weeks postpartum
Plan to share: No — 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.
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This study is not yet recruiting, as verified in Apr 2024. You cannot join it, but the record below documents what was studied.
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