Real-life Implementation Randomized Clinical Trial Assessing Effectiveness of Powerly - Science-based Digital Intervention Preventing Postpartum Depression and Anxiety
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 140
- 试验地点
- 1
- 主要终点
- DASS (Depression, Anxiety, and Stress Scales)
研究概览
简要总结
The goal of this clinical trial is to determine if the Powerly app can help prevent postpartum depression and anxiety in healthy pregnant women.
The main questions it aims to answer are:
- Does the Powerly app reduce postpartum depression and anxiety?
- Does it improve emotion regulation and maternal bonding with a child?
Researchers will compare two groups: one using the Powerly app and the other receiving care as usual (CAU) to see if the app leads to better mental health outcomes.
Participants will:
- Use the Powerly app for four weeks (if in the intervention group).
- Complete mental health assessments before the study, after four weeks, and six weeks postpartum.
详细描述
Pregnancy is a period of significant emotional and physical changes, with up to 30% of expecting mothers experiencing high stress. After birth, around 15-20% of new mothers suffer from postpartum depression, and 25-35% experience anxiety. Despite broad availability of mobile apps aimed at these challenges, none of them have been rigorously tested through clinical studies. To fill this gap, we developed Powerly, a science-based mobile app designed to help prevent postpartum depression and anxiety.
In this study, 140 healthy pregnant women will be randomly assigned to one of two groups: one will use the Powerly app for four weeks, while the other will receive care as usual (CAU). Powerly is grounded in cognitive behavioral therapy (CBT) and personalized to the individual's needs, with input from healthcare professionals and pregnant women. We will collect information on participants' mental health at three points: before they start using the app, after four weeks of app use / CAU, and six weeks after giving birth. The app's effectiveness will be evaluated by examining improvements in mental health outcomes, such as reduced rates of postpartum depression and anxiety, better emotion regulation, and stronger maternal bonding with a baby.
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
- Double (Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- •being between 24 and 32 weeks pregnant,
- •owning an iPhone,
- •having sufficient fluency in German language
排除标准
- •high-risk pregnancies,
- •history of substance abuse and psychiatric disorders such as bipolar disorder, schizophrenia, or other psychotic disorders,
- •current use of professional face-to-face psychotherapeutic support,
- •participation in other clinical trials or interventions at the same time
结局指标
主要结局
DASS (Depression, Anxiety, and Stress Scales)
时间窗: From baseline measurement until the second follow-up measurement at 6 weeks postpartum
a validated set of brief scales consisting of 21 items used to measure the severity of depression, anxiety, and stress symptoms
PDSS (Postpartum Depression Screening Scale)
时间窗: Collected only at second follow-up measurement 6 weeks postpartum
a comprehensive tool comprising 35 items designed to identify symptoms of postpartum depression, including aspects such as sleep and eating disturbances, insecurity, emotional lability, guilt, and shame
次要结局
- CERQ (Cognitive Emotion Regulation Questionnaire)(From baseline measurement until the second follow-up measurement at 6 weeks postpartum)
- PASS-C (Positive Appraisal Style scale - content)(From baseline measurement until the second follow-up measurement at 6 weeks postpartum)
- BRS (Brief Resilience Scale)(From baseline measurement until the second follow-up measurement at 6 weeks postpartum)
- BSS-RI (Birth Satisfaction Scale - Revised Indicator)(Collected only at second follow-up measurement 6 weeks postpartum)
- PBQ (Postpartum Bonding Scale)(Collected only at second follow-up measurement 6 weeks postpartum)
- mARM (mobile Agnew Relationship Measure)(Collected only at first follow-up measurement after 4 weeks of study)
- uMARS (user version of the Mobile Application Rating Scale)(Collected only at first follow-up measurement after 4 weeks of study)
- MFA (Maternal-Fetal Attachment Scale)(From baseline measurement until first follow-up measurement after 4 weeks of study)
- GSE (General Self-Efficacy Scale)(From baseline measurement until the second follow-up measurement at 6 weeks postpartum)
- Adherence(Collected passively during app use period (4 weeks))
研究者
Marta Marciniak
Dr
Erasmus University Rotterdam