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

Study acronym: ePerinatal-RCT
StatusRecruiting
PhaseNot applicable
Started
View on ClinicalTrials.gov ↗

Record History

  1. Recruitment opened
    • Study sites: 0 to 1
    • Start date changed from estimate of May 30, 2026 to Jul 15, 2026
    v2
  2. Study First Submitted
  • Stopped: an ongoing trial was terminated, suspended or withdrawn.
  • Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
  • Minor: routine progress and housekeeping, such as sites added or enrollment closed.
University of Seville
44 trials monitored
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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.
Trial Details
NCT Number NCT07613008
Lead Sponsor University of Seville
Collaborators: Junta de Andalucia, Health Service of Andalucia
Conditions
(from sponsor)		 Perinatal Depression, Perinatal Anxiety
Related terms Anxiety Disorders, Depression
Enrollment 3,000 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov