This study is part of the e-Perinatal project, funded by the European Research Council. This research project will follow the first three phases recommended by the Medical Research Council (MRC) framework for the development and evaluation of complex interventions (Skivington et al., 2021).
The primary aim is to evaluate the feasibility and acceptability of implementing an innovative, personalized mobile health (mHealth) intervention designed for the universal prevention of perinatal mental disorders. Using a pilot, two-arm, cluster-randomized hybrid type 1 clinical trial, the study will assess key implementation outcomes and preliminary effectiveness indicators. The findings will inform the design of a future large clinical trial, intending to evaluate the effectiveness, cost-effectiveness, and implementation of the intervention as part of maternal care.
Must receive an invitation to participate from a healthcare professional at one of the participating primary healthcare centers
Must be pregnant for at least 16 weeks or have given birth within the last 5 months at the time of enrollment
Must be at least 18 years old
Must have access to a mobile phone and internet connection
Meet diagnostic criteria for anxiety or depression, as determined by a structured clinical interview
Be on a waiting list or currently receiving psychological or pharmacological treatment for any mental health or substance use condition
There are no exclusion criteria for partners
University of Seville
Lead sponsor
Health Service of Andalucia
Collaborator
Junta de Andalucia
Collaborator