Abstract / Summary
Abstract Background : Postpartum depression (PPD) is a common condition that can negatively affect maternal well-being and child development. Cognitive behavioral therapy an effective psychological treatment, but access is limited in many settings. Internet-based cognitive behavioral therapy offers a scalable alternative that can be delivered flexibly at home. This trial aims to evaluate the effectiveness and safety of a self-guided internet-based intervention, iCARE, compared to treatment as usual for mothers with symptoms of PPD. Methods : This is a two-arm, parallel-group, randomized controlled superiority trial. Mothers within six months postpartum with an Edinburgh Postnatal Depression Scale score of 7–30 will be recruited through health nurses in 21 Danish municipalities and nationwide via self-recruitment through a project website. After baseline assessment, participants will be randomized 1:1 to iCARE plus usual care or usual care alone, stratified by symptom severity and recruitment pathway. The primary outcome is change in depressive symptoms from baseline to two months, with a secondary endpoint at six months. Key secondary outcomes include anxiety, functioning, automatic negative thoughts, and parental stress. Analyses will follow the intention-to-treat principle. Missing data will be handled with multiple imputation. Safety procedures include monitoring of symptom scores and predefined referral pathways for participants reporting self-harm thoughts or deterioration of depressive symptoms. Discussion : This trial will provide evidence on the effectiveness and safety of a self-guided digital intervention for PPD in a real-world setting. If effective, iCARE could improve access to psychological support and reduce treatment gaps for mothers experiencing symptoms of PPD and potentially be implemented in a stepped care approach. Findings will inform future implementation strategies in public health systems. Trial registration: ClinicalTrials.gov ID: NCT07384273