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

This is the authors' abstract. We don't add key points for this paper.

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. 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. 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. NCT06610552 • Powerly is an mHealth intervention aiming to prevent postpartum depression and anxiety. • Powerly uses CBT-based techniques, offering personalized psychological support. • The study will include 140 healthy pregnant participants in a two-arm RCT. • 70 participants will receive access to Powerly, and 70 will receive care as usual. • Outcome measures include mental health, emotion regulation, and mother-child bonding.