Development of Powerly, unguided mobile app intervention preventing postpartum depression and anxiety & study protocol of randomized clinical trial

IF 3.6 2区 医学 Q1 HEALTH CARE SCIENCES & SERVICES
Marta A. Marciniak , Judith Rohde , Kenneth S.L. Yuen , Harald Binder , Henrik Walter , Matthias J. Wieser , Raffael Kalisch , Karin Roelofs , Birgit Kleim
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Abstract

Background

Up to 30 % of pregnant individuals experience high levels of stress. At the same time, 15–20 % of new mothers develop postpartum depression, and 25–35 % experience postpartum anxiety. Mobile applications have the potential to provide an accessible, scalable solution to these mental health challenges. However, previous evidence indicates that none of the commercially available apps for perinatal depression and anxiety have been rigorously evaluated through randomized clinical trials (RCTs), and the quality of these apps remains moderate. In response to this gap, we aim to develop and empirically evaluate Powerly, a mobile app intervention designed to prevent postpartum depression and anxiety.

Methods

We will conduct a two-arm RCT with 140 healthy pregnant participants to assess the impact of Powerly use compared to care as usual (CAU). Powerly is based on cognitive behavioral therapy techniques and developed in consultation with stakeholders, including healthcare professionals and pregnant individuals. It will offer personalized psychological support tailored to users' needs for four weeks. Self-reported mental health assessments will be collected at baseline, after four weeks of app use, and six weeks postpartum.

Discussion

We anticipate that participants using Powerly will demonstrate significant improvements in mental health outcomes, including reduced rates of postpartum depression, compared to the CAU group. Additionally, we expect positive changes in emotion regulation, resilience, and mother and child outcomes, such as enhanced maternal bonding and a more positive birth experience. If proved effective, Powerly can offer a scalable, publicly accessible solution for pregnant individuals in need.

Trial registration

NCT06610552
Powerly无导向手机app干预产后抑郁、焦虑的开发及随机临床试验研究方案
背景:高达30%的孕妇承受着高水平的压力。同时,15 - 20%的新妈妈患有产后抑郁症,25 - 35%的新妈妈患有产后焦虑。移动应用程序有可能为这些心理健康挑战提供可访问的、可扩展的解决方案。然而,之前的证据表明,市面上用于围产期抑郁和焦虑的应用程序都没有经过随机临床试验(rct)的严格评估,这些应用程序的质量仍然中等。针对这一差距,我们旨在开发并实证评估Powerly,一款旨在预防产后抑郁和焦虑的移动应用程序干预。方法我们将对140名健康孕妇进行一项双臂随机对照试验,以评估与常规护理(CAU)相比,强力使用的影响。Powerly基于认知行为治疗技术,并与包括医疗保健专业人员和孕妇在内的利益相关者协商开发。它将根据用户的需求提供为期四周的个性化心理支持。自我报告的心理健康评估将在基线、应用程序使用四周后和产后六周收集。我们预计,与CAU组相比,使用powery的参与者在心理健康结果方面会有显著改善,包括产后抑郁症的发生率降低。此外,我们预计情绪调节、恢复力和母婴结果将发生积极变化,例如增强母亲关系和更积极的分娩体验。如果被证明是有效的,Powerly可以为有需要的孕妇提供可扩展的、可公开访问的解决方案。审判registrationNCT06610552
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来源期刊
CiteScore
6.50
自引率
9.30%
发文量
94
审稿时长
6 weeks
期刊介绍: Official Journal of the European Society for Research on Internet Interventions (ESRII) and the International Society for Research on Internet Interventions (ISRII). The aim of Internet Interventions is to publish scientific, peer-reviewed, high-impact research on Internet interventions and related areas. Internet Interventions welcomes papers on the following subjects: • Intervention studies targeting the promotion of mental health and featuring the Internet and/or technologies using the Internet as an underlying technology, e.g. computers, smartphone devices, tablets, sensors • Implementation and dissemination of Internet interventions • Integration of Internet interventions into existing systems of care • Descriptions of development and deployment infrastructures • Internet intervention methodology and theory papers • Internet-based epidemiology • Descriptions of new Internet-based technologies and experiments with clinical applications • Economics of internet interventions (cost-effectiveness) • Health care policy and Internet interventions • The role of culture in Internet intervention • Internet psychometrics • Ethical issues pertaining to Internet interventions and measurements • Human-computer interaction and usability research with clinical implications • Systematic reviews and meta-analysis on Internet interventions
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