Leveraging on Virtual Engagement for Maternal Understanding & Mood-enhancement "LoVE4MUM" Mobile Application- A Protocol for Pilot Randomized Control Trial for Preventing Postpartum Depression
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 64
- 试验地点
- 4
- 主要终点
- Postpartum Depression
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- Single (Investigator)
入排标准
- 年龄范围
- 19 Years 至 50 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- •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
排除标准
- •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
结局指标
主要结局
Postpartum Depression
时间窗: 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.
次要结局
- Postpartum Mental Health Literacy(Baseline, 1 week and 6 weeks postpartum)
- Automatic Negative Frequency(Baseline, 1 week and 6 weeks postpartum)
研究者
Siti Sabrina binti Kamarudin
Principal Investigator
National Institutes of Health, Ministry of Health Malaysia