Feasibility Study and Pilot Hybrid Effectiveness-Implementation Trial for the Universal Prevention of Maternal Perinatal Mental Disorders As Normalized Routine Practice (e-Perinatal Pilot)

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).

This study aims to evaluate the feasibility and acceptability of implementing an innovative, personalized mobile health (mHealth) intervention designed to prevent maternal perinatal mental health disorders. Using a pilot cluster-randomized hybrid type 1 clinical trial, the study will explore key implementation aspects and preliminary data of intervention's effectiveness. This study will set the groundwork for a future full clinical trial, intending to test the effectiveness of a personalized mHealth intervention for enhancing overall perinatal mental health and its implementation into routine prenatal and postnatal maternal health care.

This pilot clinical study investigates the feasibility and acceptability of a cluster-randomized hybrid type 1 clinical trial, aiming to assess the implementation and potential effectiveness of an innovative, personalized mobile health (mHealth) intervention -the e-Perinatal App- for the prevention of maternal perinatal mental health disorders within primary care settings. The primary objective is to evaluate the feasibility of integrating this app into routine prenatal and postnatal care, enhancing maternal mental health outcomes during the perinatal period. The participants will be women during the perinatal period and their partners.

Specific objectives of the study include:

1. To assess the acceptability of the e-Perinatal App.
2. To evaluate the preliminary effectiveness of the intervention in reducing the incidence of depression and anxiety in women, alleviating depressive and anxious symptoms in their partners, and promoting infant health and development.
3. To assess aspect related with evaluation design.

The study hypothesizes that the personalized e-Perinatal mHealth intervention will be both feasible and acceptable to pregnant and new mothers, their partners, and healthcare professionals involved in routine prenatal and postnatal maternal health care.

Participants (i.e., pregnant or postpartum women and their partners) will be recruited from primary care settings. They will be clustered and assigned to either the intervention group, which will receive the e-Perinatal personalized mHealth intervention, or the control group, which will continue with usual care.

Eligibility Criteria:
Inclusion criteria for mothers:

* Must receive an invitation to participate from a healthcare professional at one of the study's participating health centers
* Must be pregnant for less than 28 weeks or have given birth within the last 5 months
* Must be at least 18 years of age
* Must have access to a mobile phone and to internet
* 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 their partner (mother already participating)
* Must be at least 18 years of age
* Must have access to a mobile phone and to internet
* Must be able to read, write, and understand Spanish
* Must have a personal email account

Exclusion criteria for mothers:

* Meet the criteria for diagnosis of anxiety or depression through a structured clinical interview
* Are on a waiting list or currently receiving psychological or pharmacological treatment for any mental health condition or substance use

Exclusion criteria for partners (or significant others):

* There are no exclusion criteria for partners