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

RecruitingNAAges 18 Years - anyAllUniversity of Seville
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In plain words

What the trial is, and whether it could suit you

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 in real-world primary healthcare settings.

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๐Ÿ“‹ Eligibility rules (as published)
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
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What it tests

  • The e-Perinatal intervention is a personalized mobile health (mHealth) program
  • Standard routine maternal care
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Where

1 site
Primary Health Care Center Mairena del Aljarafe - Ciudad Expo
Mairena del Aljarafe, Spain
๐Ÿค Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible โ€” always decide together with your own doctor.
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