Abstract / Summary
Abstract Background Pregnancy and childbirth are major life transitions that can significantly impact women’s mental health, with depression and anxiety being the most commonly reported. International and Swedish studies estimate that up to one in four women experience anxiety or depressive symptoms during pregnancy or postpartum. Poor maternal mental health is associated with adverse outcomes for both mother and child, including preterm birth and low birth weight. Psychological resilience has emerged as a key protective factor, linked to reduced psychological distress and improved emotional regulation during pregnancy. Despite the potential of scalable digital interventions, few have been scientifically evaluated or tailored to the perinatal period. Objectives To estimate the effectiveness of a new digital intervention (the HealthyMoms4MentalHealth-app) on psychological resilience among women during the perinatal period. Methods The study is a two-arm parallel-group randomized controlled trial. A total of 440 pregnant women will be randomized to either the intervention group (HealthyMoms4MentalHealth-app + standard care) or control group (active control-app + standard care). Outcomes will be assessed at baseline prior to randomization (12–14 gestational weeks), and follow-ups in late pregnancy (35–37 gestational weeks), and postpartum (8–9 weeks). The primary outcome will be psychological resilience and secondary outcomes include psychological wellbeing and depressive symptoms. Exploratory outcomes will include fear of childbirth, self-compassion, pre- and postnatal attachment and health behaviours. The intervention was developed using a human-centred design approach and is grounded in positive psychology, self-compassion, and empirical data from qualitative interviews with perinatal care professionals. The intervention begins between gestational weeks 12–14 and continues until 8 weeks postpartum and is aimed to be a universal, health promotive and upstream digital intervention targeting a large proportion of the perinatal population. The active control app include content on healthy eating, healthy weight gain and physical activity during pregnancy. Conclusion This trial will provide evidence on the effectiveness of a digital mental health intervention tailored to the perinatal period. Findings may inform future strategies for scalable, accessible health promotive mental health support for pregnant and postpartum women. Trial registration The trial has been registered at ClinicalTrial.gov: trial identifier NCT06862193; trial date 5th March 2025. Full protocol and statistical analysis plan will be available with the trial’s registration record. Protocol version 3.0, 3rd November 2025.