| Abstract |
INTRODUCTION: The perinatal period is associated with an increased risk of new-onset depression and anxiety in both mothers and their partners. Despite the significant impact of perinatal mental disorders (PMD) on families and healthcare systems, access to mental health services remains limited due to structural barriers. Mobile health (mHealth) interventions offer a scalable and accessible strategy for universal prevention, but few have been integrated into routine maternal care and evaluated in real-world settings. PROTOCOL: This study presents the protocol for a two-arm, cluster-randomised, hybrid type 1 pilot trial designed to evaluate the feasibility, acceptability, and preliminary effectiveness of the e-Perinatal app, a personalised mHealth innovation for universal PMD prevention. Eight Primary Healthcare Centres in Andalusia, Spain, will be randomised in a 1:1 ratio to the intervention or control arm. The intervention group will receive access to the e-Perinatal app along with specialised training in perinatal mental health for healthcare professionals involved in routine maternal care. The control group will receive routine maternal care along with monthly psychoeducational emails. A total of 96 pregnant or postpartum women (up to five months postpartum) and their partners will be recruited. Primary outcomes are feasibility and acceptability of the e-Perinatal app as a universal preventive intervention integrated within routine maternal care. Secondary outcomes include implementation measures (i.e., adoption, fidelity, and appropriateness) and preliminary effectiveness indicators (i.e., cumulative incidence of perinatal depression and anxiety, changes in symptoms severity, postnatal post-traumatic stress disorder, and subjective well-being). Additional outcomes include other implementation measures (e.g., participants experiences and reasons to dropout), family dynamics, infant development, app usability, and healthcare utilisation. Data will be analysed using mixed methods. DISCUSSION: This pilot trial will provide key information on the feasibility of integrating a personalised mHealth intervention into routine maternal care, thereby informing the design of a subsequent large-scale trial. |
