Feasibility Study and Pilot Hybrid Effectiveness-Implementation Trial for the Universal Prevention of Maternal Perinatal Mental Disorders as Normalized Routine Practice (e-Perinatal Pilot)
Recruiting · NCT06640907 · Interventional (participants receive a specific treatment) · Lead sponsor: University of Seville
View the official record on ClinicalTrials.gov →Interventions studied
What this trial is about
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.
Who can take part
Inclusion criteria
- for mothers:
- 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
- Inclusion criteria for partners (or significant others):
- 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 criteria
- for mothers:
- 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
- Exclusion criteria for partners (or significant others):
- There are no exclusion criteria for partners
Where it is running
2 locations listed.
- Primary Health Care Center Mairena del Aljarafe - Ciudad Expo - Mairena del Aljarafe, Seville, Spain
- Primary Health Care Center Mairena del Aljarafe - Ciudad Expo - Mairena del Aljarafe, Seville, Spain