用于预防产后抑郁症的LoVE4MUM移动应用程序：一项试点随机对照试验的方案

LoVE4MUM Mobile App to Prevent Postpartum Depression: Protocol for a Pilot Randomized Controlled Trial.

作者信息

Kamarudin Siti Sabrina, Idris Idayu Badilla, Sharip Shalisah, Ahmad Norfazilah

机构信息

Clinical Research Center Hospital Shah Alam, Institute for Clinical Research, National Institute for Health, Ministry of Health Malaysia, Shah Alam, Malaysia.

Department of Public Health Medicine, Faculty of Medicine, Universiti Kebangsaan Malaysia, Cheras, Malaysia.

出版信息

JMIR Res Protoc. 2025 Jan 27;14:e63564. doi: 10.2196/63564.

DOI:10.2196/63564

PMID:39869891

原文链接:https://pmc.ncbi.nlm.nih.gov/articles/PMC11811676/

Abstract

BACKGROUND

Postpartum depression remains a significant concern, posing substantial challenges to maternal well-being, infant health, and the mother-infant bond, particularly in the face of barriers to traditional support and interventions. Previous studies have shown that mobile health (mHealth) interventions offer an accessible means to facilitate early detection and management of mental health issues while at the same time promoting preventive care.

OBJECTIVE

This study aims to evaluate the effectiveness of the Leveraging on Virtual Engagement for Maternal Understanding & Mood-enhancement (LoVE4MUM) mobile app, which was developed based on the principles of cognitive behavioral therapy and psychoeducation and serves as an intervention to prevent postpartum depression.

METHODS

This single-blinded, pilot randomized controlled trial includes 64 mothers recruited from the postnatal ward and randomized using a 1:1 ratio to receive either postpartum care (treatment as usual) or postpartum care (treatment as usual) plus the self-guided LoVE4MUM mobile app. The primary outcome is the effectiveness of the mobile app at improving postpartum depression. Secondary outcomes are changes in the mental health literacy score and negative automatic thoughts, which are collected using a self-reported questionnaire.

RESULTS

Patient recruitment began on September 1, 2024. As of January 1, 2025, recruitment was successfully completed, with a total of 72 participants enrolled: 36 in the intervention group and 36 in the control group . The final results are anticipated to be available by March 2025, and publication is expected by the end of 2025.

CONCLUSIONS

By examining the LoVE4MUM app alongside standard postpartum care, this pilot randomized controlled trial seeks to offer preliminary evidence on the potential of mHealth tools to improve maternal mental health as well as to reduce postpartum depression symptoms. The findings are expected to contribute to the future development of effective, accessible, and scalable interventions for mothers.

TRIAL REGISTRATION

ClinicalTrials.gov NCT06366035; https://clinicaltrials.gov/study/NCT06366035.

INTERNATIONAL REGISTERED REPORT IDENTIFIER (IRRID): PRR1-10.2196/63564.

摘要

背景

产后抑郁症仍然是一个重大问题，对母亲的幸福、婴儿健康以及母婴关系构成了巨大挑战，尤其是在面对传统支持和干预存在障碍的情况下。先前的研究表明，移动健康（mHealth）干预措施提供了一种便捷的方式，有助于早期发现和管理心理健康问题，同时促进预防保健。

目的

本研究旨在评估“利用虚拟参与促进母亲理解与情绪提升”（LoVE4MUM）移动应用程序的有效性，该应用程序是基于认知行为疗法和心理教育原则开发的，作为预防产后抑郁症的一种干预措施。

方法

这项单盲、试点随机对照试验纳入了64名从产后病房招募的母亲，并按1:1的比例随机分组，分别接受产后护理（常规治疗）或产后护理（常规治疗）加自我引导的LoVE4MUM移动应用程序。主要结局是移动应用程序在改善产后抑郁症方面的有效性。次要结局是使用自我报告问卷收集的心理健康素养得分和消极自动思维的变化。