Periodic Reporting for period 1 - e-Perinatal (Universal prevention of maternal perinatal mental disorders and its implementation as normalized routine practice)
Reporting period: 2023-01-01 to 2025-06-30
Mental health during the perinatal period (i.e. the time spanning pregnancy and the first year after childbirth) is a critical yet often overlooked public health issue. Up to 20% of women experience perinatal mental health disorders (PMD), which can severely impact their mental and physical well-being, as well as that of their children and families. If left untreated, these conditions may lead to long-term consequences, including family dysfunction and impaired child development. Despite their high prevalence, PMD remain underdiagnosed and undertreated, partly due to stigma and limited access to adequate healthcare services.
Current efforts to treat PMD have not significantly reduced their incidence, as new cases continue to emerge. Primary prevention, which focuses on mitigating risk factors and enhancing protective factors before symptom onset, is crucial. Universal preventive approaches, integrated into routine maternal and child healthcare, can help reduce stigma and improve accessibility. However, evidence regarding their effectiveness and successful implementation in real-world settings remains limited. This gap highlights the urgent need for innovative solutions to prevent PMD and mitigate their widespread consequences.
To address this challenge, the e-Perinatal Project was conceived. Its primary objective is to evaluate the effectiveness of universal preventive interventions for maternal perinatal mental disorders and to facilitate their integration into routine global healthcare practices.
By combining classical and emerging methodological frameworks—including the Biopsychosocial Model, Family Systems Theory, Self-Determination Theory, and Normalization Process Theory—with digital solutions, the project aims to demonstrate the effectiveness of universal prevention strategies in reducing PMD incidence and fostering family well-being.
The project objectives are as follows:
(a) To develop a personalized mobile-health (mHealth) preventive intervention for mothers and their partners, incorporating evidence-based psychological components and tailored health recommendations.
(b) To assess the intervention’s effectiveness in reducing the incidence of maternal depression and anxiety disorders, alleviating depressive and anxious symptoms in fathers/partners, and promoting child health and development.
(c) To apply causal methodology to identify the underlying mechanisms that contribute to the intervention’s effectiveness.
(d) To analyze the implementation process and determine the factors that facilitate or hinder successful adoption.
e-Perinatal ERC project leads a new paradigm to investigate the prevention of perinatal mental disorders and the implementation of preventive programs into global healthcare services.
Current efforts to treat PMD have not significantly reduced their incidence, as new cases continue to emerge. Primary prevention, which focuses on mitigating risk factors and enhancing protective factors before symptom onset, is crucial. Universal preventive approaches, integrated into routine maternal and child healthcare, can help reduce stigma and improve accessibility. However, evidence regarding their effectiveness and successful implementation in real-world settings remains limited. This gap highlights the urgent need for innovative solutions to prevent PMD and mitigate their widespread consequences.
To address this challenge, the e-Perinatal Project was conceived. Its primary objective is to evaluate the effectiveness of universal preventive interventions for maternal perinatal mental disorders and to facilitate their integration into routine global healthcare practices.
By combining classical and emerging methodological frameworks—including the Biopsychosocial Model, Family Systems Theory, Self-Determination Theory, and Normalization Process Theory—with digital solutions, the project aims to demonstrate the effectiveness of universal prevention strategies in reducing PMD incidence and fostering family well-being.
The project objectives are as follows:
(a) To develop a personalized mobile-health (mHealth) preventive intervention for mothers and their partners, incorporating evidence-based psychological components and tailored health recommendations.
(b) To assess the intervention’s effectiveness in reducing the incidence of maternal depression and anxiety disorders, alleviating depressive and anxious symptoms in fathers/partners, and promoting child health and development.
(c) To apply causal methodology to identify the underlying mechanisms that contribute to the intervention’s effectiveness.
(d) To analyze the implementation process and determine the factors that facilitate or hinder successful adoption.
e-Perinatal ERC project leads a new paradigm to investigate the prevention of perinatal mental disorders and the implementation of preventive programs into global healthcare services.
WP.1: Development of the e-Perinatal App
All planned tasks have been completed, including the development of the Data Management Plan and the acquisition of ethical approval (Task 1.1). The first prototype of the app was developed over two years in collaboration with a software company, following a co-design approach with stakeholders (Task 1.2). This process involved iterative focus groups with diverse participants (e.g. perinatal women, LGBTQ+ individuals, and healthcare professionals), leading to the beta version (M1).
A comprehensive intervention framework was established, integrating psychology, nursing, nutrition, medicine, and physical activity. It was structured into three main modules, 18 sub-modules, and three content formats. In parallel, a data model, content management platform, and user registration system were developed.
A clinical rule-based filtering algorithm was implemented (Task 1.3) but no AI was used at this stage. Usability testing (Task 1.4) involving interviews and the System Usability Scale (SUS), yielded a score of 60.5 below the acceptable range. Consequently, expert heuristic evaluations were conducted to detect usability issues and recommend improvements, which guided subsequent refinements (Task 1.5).
Scientific dissemination included five published manuscripts, with six more in preparation for submission in late 2025-early 2026. Findings were also presented at international conferences, including the Marcé Conference 2024, where Prof. Motrico led a symposium.
WP.2: Feasibility and Pilot RCT
Recruitment of Primary Healthcare Centres (PHCs) and professionals, in collaboration with the Andalusian Health Service (SAS), was completed (Task 2.1). Eight PHCs in Andalucía, Spain, were randomly assigned to intervention and control groups, and trained professionals received manuals and technical support (Task 2.2). REDCap was fully deployed for quantitative data management. Participant recruitment started on 2 May 2025 and was completed on 31 July 2025. In total, 89 women and 15 partners were enrolled in the intervention group, and 63 women and 8 partners in the control group.
The feasibility phase (Task 2.3.) has already started, as recruitment rates and participant engagement were monitored during recruitment. The formal evaluation of feasibility and implementation outcomes will begin after the completion of participant recruitment, which had been delayed by six months due to additional app development requirements.
For scientific dissemination, the feasibility RCT protocol (P1) was presented at Marcé Conference 2024, and the corresponding manuscript has been published in Open Research Europe.
WP.3: Evaluation in a Hybrid RCT
Ethical approval has been secured, and preparatory activities are ongoing. Discussions have been held with training coordinators to prepare the training of midwives for the full RCT. Meetings with policymakers from several health districts in Andalucía have also taken place to finalise the participation of PHCs. Emails were sent to health centres in selected districts to explore participation (Task 3.1). The objective is to initiate the full RCT in January 2026.
All planned tasks have been completed, including the development of the Data Management Plan and the acquisition of ethical approval (Task 1.1). The first prototype of the app was developed over two years in collaboration with a software company, following a co-design approach with stakeholders (Task 1.2). This process involved iterative focus groups with diverse participants (e.g. perinatal women, LGBTQ+ individuals, and healthcare professionals), leading to the beta version (M1).
A comprehensive intervention framework was established, integrating psychology, nursing, nutrition, medicine, and physical activity. It was structured into three main modules, 18 sub-modules, and three content formats. In parallel, a data model, content management platform, and user registration system were developed.
A clinical rule-based filtering algorithm was implemented (Task 1.3) but no AI was used at this stage. Usability testing (Task 1.4) involving interviews and the System Usability Scale (SUS), yielded a score of 60.5 below the acceptable range. Consequently, expert heuristic evaluations were conducted to detect usability issues and recommend improvements, which guided subsequent refinements (Task 1.5).
Scientific dissemination included five published manuscripts, with six more in preparation for submission in late 2025-early 2026. Findings were also presented at international conferences, including the Marcé Conference 2024, where Prof. Motrico led a symposium.
WP.2: Feasibility and Pilot RCT
Recruitment of Primary Healthcare Centres (PHCs) and professionals, in collaboration with the Andalusian Health Service (SAS), was completed (Task 2.1). Eight PHCs in Andalucía, Spain, were randomly assigned to intervention and control groups, and trained professionals received manuals and technical support (Task 2.2). REDCap was fully deployed for quantitative data management. Participant recruitment started on 2 May 2025 and was completed on 31 July 2025. In total, 89 women and 15 partners were enrolled in the intervention group, and 63 women and 8 partners in the control group.
The feasibility phase (Task 2.3.) has already started, as recruitment rates and participant engagement were monitored during recruitment. The formal evaluation of feasibility and implementation outcomes will begin after the completion of participant recruitment, which had been delayed by six months due to additional app development requirements.
For scientific dissemination, the feasibility RCT protocol (P1) was presented at Marcé Conference 2024, and the corresponding manuscript has been published in Open Research Europe.
WP.3: Evaluation in a Hybrid RCT
Ethical approval has been secured, and preparatory activities are ongoing. Discussions have been held with training coordinators to prepare the training of midwives for the full RCT. Meetings with policymakers from several health districts in Andalucía have also taken place to finalise the participation of PHCs. Emails were sent to health centres in selected districts to explore participation (Task 3.1). The objective is to initiate the full RCT in January 2026.
The e-Perinatal Project has achieved a significant breakthrough by developing the e-Perinatal App, an innovative and personalized mHealth intervention for the universal prevention of maternal perinatal mental disorders (PMD). This intervention is designed for integration into routine maternal care, ensuring scalability and sustainability. Its development has involved the collaboration of key stakeholders, including healthcare professionals, mothers, and fathers, thereby guaranteeing that the app is relevant and responsive to the needs of its intended users.
Engaging stakeholders from the earliest stages of content design and development is expected to enhance adoption rates, optimize delivery, and reduce dropout. Furthermore, the project directly addresses existing gaps in digital interventions, including the limited consideration of fathers’ needs and the scarce inclusion of diverse family structures, particularly LGBTQ+ non-birthing parents.
A critical barrier identified during the project was the lack of validated instruments for assessing psychosocial outcomes in the Spanish perinatal population. To overcome this limitation, a parallel study was launched to validate and adapt key assessment tools, ensuring cultural and clinical adequacy. This ongoing work will allow research and clinical practice in Spain to rely on validated measures tailored to perinatal women and their partners. As part of this effort, five manuscripts are currently under development, and eight additional manuscripts are planned.
Engaging stakeholders from the earliest stages of content design and development is expected to enhance adoption rates, optimize delivery, and reduce dropout. Furthermore, the project directly addresses existing gaps in digital interventions, including the limited consideration of fathers’ needs and the scarce inclusion of diverse family structures, particularly LGBTQ+ non-birthing parents.
A critical barrier identified during the project was the lack of validated instruments for assessing psychosocial outcomes in the Spanish perinatal population. To overcome this limitation, a parallel study was launched to validate and adapt key assessment tools, ensuring cultural and clinical adequacy. This ongoing work will allow research and clinical practice in Spain to rely on validated measures tailored to perinatal women and their partners. As part of this effort, five manuscripts are currently under development, and eight additional manuscripts are planned.