Ignite Creation Date:
2024-05-06 @ 8:23 PM
Last Modification Date:
2024-10-26 @ 3:26 PM
Study NCT ID:
NCT06366035
Status:
NOT_YET_RECRUITING
Last Update Posted:
2024-04-16
First Post:
2024-04-10
Brief Title:
LoVE4MUM Virtual Engagement for Preventing Postpartum Depression
Sponsor:
National Institutes of Health Ministry of Health Malaysia
Organization:
National Institutes of Health Ministry of Health Malaysia
Study Overview
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
Status:
NOT_YET_RECRUITING
Status Verified Date:
2024-04
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
LoVE4MUM
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 11 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
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 11 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 Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None