Effectiveness of a Smartphone Application for Mothers at High Risk for Postpartum Depression: A Randomized Controlled Trial
试验速览
- 阶段
- 不适用
- 状态
- 进行中(未招募)
- 入组人数
- 79
- 试验地点
- 1
- 主要终点
- The primary outcome is the symptoms of PPD measured by the Edinburgh Postnatal Depression Scale (EPDS)
研究概览
简要总结
Effectiveness of a Smartphone Application for Mothers at High Risk for Postpartum Depression: A Randomized Controlled Trial Abstract
Aim: This study aims to determine the effectiveness of a smartphone application in reducing symptoms of postpartum depression among Jordanian women.
Background: Postpartum depression (PPD) is a serious mental health condition affecting an estimated 14-27% of mothers and negatively impacting infant health. Social support and certain psychological therapies have been shown to reduce depressive symptoms in postpartum women. Smartphone applications may provide a viable means of delivering psychological interventions to mothers experiencing such symptoms.
Method: A randomized controlled trial will be conducted at two maternal and child health clinics in Irbid, Jordan. A total of 295 women will be invited to participate and will be asked to provide sociodemographic data and complete the Edinburgh Postnatal Depression Scale (EPDS) at 6-8 weeks (baseline) and again at 3 months postpartum. Women with a depressive symptom score of ≥13 (n ≈ 79) will be randomly assigned to either the intervention group (n ≈ 58) or the control group (n ≈ 57). The intervention will involve an Android smartphone application called Serene Motherhood, which will enable mothers to access evidence-based cognitive techniques and health information at any time.
详细描述
Postpartum depression (PPD) is a mental health condition affecting a substantial proportion of mothers during the first year after childbirth. It is characterized by depressed mood, anxiety, feelings of powerlessness or worthlessness, sleep disturbances, and, in some cases, suicidal thoughts. PPD significantly impacts maternal health, leading to physical and psychological difficulties, increased risk of harmful behaviors, social withdrawal, and challenges in performing daily caregiving responsibilities. Infants of affected mothers may experience impaired physical health, irregular sleep patterns, delays in cognitive and emotional development, poor mother-infant bonding, and difficulties initiating and maintaining breastfeeding. These outcomes underscore the importance of early identification and evidence-based interventions.
Psychological interventions, including psychotherapy, support groups, and cognitive-behavioral therapy (CBT), are effective in mitigating PPD symptoms by helping mothers understand their condition, manage negative thoughts, and develop adaptive coping mechanisms. Traditionally, these interventions are delivered face-to-face, providing personal interaction and emotional support. However, multiple barriers, such as socioeconomic limitations, cultural differences, provider bias, time constraints, and limited access in rural or remote areas, often restrict participation in conventional services.
To overcome these barriers, interventions are increasingly delivered remotely through smartphone applications, telephone counseling, and video conferencing platforms. Such approaches offer scalable, flexible, and culturally sensitive options for providing psychological support, particularly to underserved populations. Smartphone applications have shown promise in delivering health education, CBT-based modules, social support, and self-care strategies, with evidence suggesting effectiveness in reducing PPD symptoms in diverse international contexts. Nonetheless, the applicability and outcomes of these interventions in Middle Eastern settings, including Jordan, remain under-investigated.
In Jordan, limited postpartum discharge education and counseling present additional challenges to maternal mental health. Many mothers receive minimal guidance before leaving healthcare facilities, highlighting the need for alternative strategies to support postpartum well-being. At the same time, widespread smartphone access-including in rural communities-offers a feasible platform for delivering interventions that address gaps in education, support, and mental health care.
Given the limited research on smartphone-based interventions for PPD in Arab populations, this study aims to evaluate the effectiveness of a smartphone application specifically designed to support mothers experiencing postpartum depressive symptoms. The study will provide preliminary evidence to inform the potential implementation of scalable digital interventions in Jordan and similar contexts, contributing to improved maternal and infant health outcomes.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Supportive Care
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 45 Years(Adult)
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Jordanian women aged 18 to 45 years.
- •Primigravida or multigravida
- •Able to speak and read Arabic
- •Between six and eight weeks postpartum
- •EPDS score of ≥13
- •Access to an Android-compatible smartphone
排除标准
- •Complications during or after childbirth
- •Newborn death or need for special/intensive care
- •Positive response ("yes") to the suicidal ideation item on the EPDS (these participants will be referred to the Prince Basma Outpatient Clinics, Mental Health Department)
研究组 & 干预措施
Intervention group
The intervention was an Android smartphone application called "Serene Motherhood," which enabled mothers to access evidence-based therapeutic cognitive techniques and health information at any time.
干预措施: Smartphone Application (Other)
Control group
Control Group who received the routine care for postpartum mothers
结局指标
主要结局
The primary outcome is the symptoms of PPD measured by the Edinburgh Postnatal Depression Scale (EPDS)
时间窗: 12 weeks per participant (from baseline assessment at 6-8 weeks postpartum to follow-up at 3 months postpartum)
The EPDS is a self-administered questionnaire consisting of ten items, with a total scoring range of 0 to 30 (Cox et al., 1987). Responses are rated on a 4-point scale (0, 1, 2, or 3) according to the severity of symptoms. Items 3, 5, and 10 are reverse-scored (i.e., 3, 2, 1, and 0). The total score is obtained by summing the scores for all ten items, after reversing the coding of negatively worded items, in accordance with the scoring guidelines to ensure consistency.
次要结局
未报告次要终点
研究者
Noor Ali
Principal Investigator
Yarmouk University
