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Effectiveness and Implementation of a Personalized mHealth Intervention for the Universal Prevention of Maternal Perinatal Mental Disorders

This study is part of the ERC-funded e-Perinatal project and represents a large-scale hybrid type 1 effectiveness-implementation cluster randomized controlled trial. The primary aim is to evaluate the effectiveness of a personalized and complex mobile health (mHealth) intervention (e-Perinatal) in the universal prevention of maternal perinatal depression and anxiety disorders. Secondary aims include evaluating the impact on paternal mental health and child development, as well as examining implementation outcomes…

ClinicalTrials.gov IDNCT07613008

PhaseNA

Enrollment3000

SponsorUniversity of Seville

Age18 Years

SexALL

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Conditions studied

Perinatal Depression, Perinatal Anxiety

About this study

Interventions

Behavioral: The e-Perinatal intervention is a personalized mobile health (mHealth) program — The e-Perinatal intervention is a personalized mobile health (mHealth) program that includes: 1) Digital micro-interventions focused on psychological, physical activity, and healthy lifestyle domains; 2) a personalized recommendation engine; 3) a social support section; 4) mental health monitoring; 5) an 'SOS' button for assistance; and 6) an appointment reminder tool. The intervention is delivered through a mobile application and is integrated into routine maternal care. Participants will use the app from recruitment (pregnancy) until 12 months of postpartum.
Other: Standard routine maternal care — Participants will receive standard maternal care as provided by the public healthcare system, including routine antenatal and postnatal visits and access to maternal education programs.

Primary outcomes

Cumulative incidence of maternal perinatal depression and anxiety disorders (Baseline and 12 months postpartum)

Eligibility information

Inclusion Criteria: \- Inclusion Criteria (Women) Must receive an invitation to participate from a healthcare professional at one of the participating primary healthcare centers Must be pregnant for at least 11 weeks 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 No diagnosis of depression or anxiety disorder at baseline Forma \- Inclusion Criteria (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: * Exclusion Criteria (Women) Current diagnosis of depression or anxiety disorder Receiving psychological or pharmacological treatment for mental health or substance use conditions \- Exclusion criteria for partners (or significant others): There are no exclusion criteria for partners

Study locations

Primary Health Care Center Mairena del Aljarafe - Ciudad Expo, Mairena del Aljarafe, Sevilla 41927 Spain

Before you participate: Varda Clinical is an independent discovery tool, not the study sponsor or a medical provider. Eligibility can only be determined by the official study team. Discuss potential risks and benefits with a qualified healthcare professional.

Source: ClinicalTrials.gov. Record last refreshed by Varda Clinical: 2026-10-02.