Feasibility Study and Pilot Hybrid Effectiveness-Implementation Trial for the Universal Prevention of Maternal Perinatal Mental Disorders as Normalized Routine Practice (e-Perinatal Pilot)
Universal Prevention of Maternal Perinatal Mental Disorders and Its Implementation as Normalized Routine Practice (e-Perinatal): Pilot Randomized Control Trial (WP2)
University of Seville
96 participants
May 2, 2025
INTERVENTIONAL
Conditions
Summary
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.
Eligibility
Inclusion Criteria11
- 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
- Must be able to read, write, and understand Spanish
- Must have a personal email account
- Must receive an invitation to participate from a woman already enrolled in the study
- Must be at least 18 years old
- Must have access to a mobile phone and internet connection
- Must be able to read, write, and understand Spanish
- Must have a personal email account
Exclusion Criteria2
- 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
Interventions
The e-Perinatal intervention combines a personalized mobile health (mHealth) app with targeted training for healthcare professionals to support perinatal mental health within routine maternal care. Participants allocated to the intervention arm will use the app for a period of two months. The app offers psychoeducational content, video-guided physical activities, mindfulness exercises, mood-tracking tools, personalized recommendations through a rule-based algorithm, and social-community features. Healthcare professionals assigned to the intervention arm receive specialized training to integrate the app into their daily practice, enhancing their ability to promote and support mental health during the perinatal period.
Standard maternal care as routinely provided by the Andalusian public healthcare system (Spain). This includes scheduled visits with midwives, nurses, and pediatrician for maternal and infant health monitoring, as well as access to childbirth education programmes. Participants also receive monthly psychoeducational emails (two months) containing general information on perinatal mental health, pregnancy, and infant development. Healthcare professionals in this arm do not receive specialized training in perinatal mental health or in the use of digital interventions, and participants do not have access to the e-Perinatal app.
Locations(1)
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NCT06640907