Effectiveness and Implementation of a Personalized mHealth Intervention for the Universal Prevention of Maternal Perinatal Mental Disorders

This clinical trial evaluates the effectiveness and implementation of the e‐Perinatalintervention, a personalized mobile health (mHealth) psychological program designed forthe universal prevention of maternal perinatal depression and anxiety disorders. Thestudy will be conducted as a two‐arm, cluster‐randomized, hybrid type 1effectiveness‐implementation trial in routine maternal care settings within primaryhealthcare centers.Primary healthcare centers will be randomized to either the intervention or control arm.Participants will include pregnant women and their partners.The primary objective is to evaluate the effectiveness of the e‐Perinatal intervention inreducing the cumulative incidence of maternal perinatal depression and anxiety disorders,assessed via structured diagnostic interviews. Secondary objectives include assessingmaternal and paternal mental health outcomes, child development outcomes, and identifyingmoderators and mediators of intervention effectiveness.In addition, the study will evaluate implementation outcomes, including acceptability,feasibility, adoption, fidelity, and barriers and facilitators to implementation inreal‐world healthcare settings.Participants in the intervention group will receive access to the e‐Perinatal appalongside usual maternal care. The e‐Perinatal app includes: 1) Digitalmicro‐interventions focused on psychological, physical activity, and healthy lifestyledomains; 2) a personalized recommendation engine; 3) a social support section; 4) mentalhealth monitoring; 5) an 'SOS' button for assistance; and 6) an appointment remindertool. Participants in the control group will receive usual maternal care.