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
Parallel
e-Perinatal personalized mHealth intervention integrated into routine maternal care
BehavioralThe 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 routine maternal care with general perinatal health information
Other interventionStandard 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.
Feasibility of the intervention
Calculation of participation rate, recruitment rate, and retention rate (follow-up rate) at all assessment points. Assessment method: Registration and follow-up records.
Early acceptability
Number of eligible women and partners who agree to participate. Assessment method: Consent forms.
Final acceptability
Evaluation of how appropriate, satisfactory, and feasible the intervention is after its implementation. Assessment method: Surveys and semi-structured interviews based on the Normalization Process Theory.
Adoption
Proportion of Primary Health Care (PHC) professionals who express their willingness to participate in the study among the total of potential professionals prior to the start of the intervention. Assessment method: Registration records.
Fidelity
Measures adherence to the study protocol by PHC professionals. Assessment method: Surveys.
Early appropriateness
Number of eligible women and number of partners invited to participate by women. Assessment method: Consent forms and recruitment records.
Final appropriateness
Suitability and relevance of the intervention for the target population and context. Assessment method: Semi-structured interviews based on the Normalization Process Theory.
Organizational readiness for implementing change
Organization's readiness for implementing changes in usual care. Assessment method: The Organizational Readiness Implementing Change (ORIC), a 12-item self-report measure. Each item is scored from 1 to 5, with higher scores indicating greater readiness for implementing change.
App quality
Objective and subjective quality, and the perceived impact of the application. Assessment method: The User Version of the Mobile Application Rating Scale (u-MARS), a 26-item self-report measure. Each item is scored from 1 to 5, with higher scores indicating better app quality.
Implementation process
App implementation process from the perspective of healthcare professionals involved in implementing complex interventions. Assessment method: The Normalization Measure Development Questionnaire (NoMAD), a 20-item self-report measure. Each item is scored from 1 to 5, with higher scores indicating more effective implementation processes.
Barriers and facilitators
Identifies barriers and facilitators impacting the integration of the intervention into routine healthcare, drawing from the experiences of users and healthcare professionals. Assessment method: Semi-structured interviews following the Normalization Process Theory (NPT) framework
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University of Seville
Lead sponsor
Health Service of Andalucia
Collaborator
Junta de Andalucia
Collaborator
