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

StatusCompleted
PhaseNot applicable
Started
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Record History

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  1. Trial completed Show 6 more changesShow less
    • Study completion date changed from estimate of Dec 2025 to Jan 31, 2026
    • Primary completion date changed from estimate of Dec 2025 to Nov 11, 2025
    • Eligibility criteria expanded, about 14 words
    • Secondary endpoints: details revised at 9 of 9 entries
    • Site details revised
    • Collaborators revised (2)
  2. Trial status: Not Yet Recruiting to Recruitingv2 Show 7 more changesShow less
    • Enrollment target: 320 to 96
    • Start date changed from estimate of Dec 2, 2024 to May 2, 2025
    • Primary endpoints revised (3)
    • Study sites: 0 to 1
    • Interventions: Personalized e-Perinatal mHealth intervention integrated in maternal routine care (Behavioral), Usual perinatal care with general prenatal… to Standard routine maternal care with general perinatal health information (Other), e-Perinatal personalized mHealth intervention integrated…
    • Eligibility criteria expanded, about 5 words
    • Study description expanded, about 4 words
  3. 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  • Stopped: an ongoing trial was terminated, suspended or withdrawn.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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Anxiety
3,263 trials monitored
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Depression
3,055 trials monitored
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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). The primary aim is to evaluate the feasibility and acceptability of implementing an innovative, personalized mobile health (mHealth) intervention designed for the universal prevention of perinatal mental disorders. Using a pilot, two-arm, cluster-randomized hybrid type 1 clinical trial, the study will assess key implementation outcomes and preliminary effectiveness indicators. The findings will inform the design of a future large clinical trial, intending to evaluate the effectiveness, cost-effectiveness, and implementation of the intervention as part of maternal care.
Trial Details
NCT Number NCT06640907
Lead Sponsor University of Seville
Collaborators: Andalusian Health Service, Junta de Andalucia
Conditions
(from sponsor)		 Perinatal Depression, Perinatal Anxiety
Related terms Anxiety Disorders, Depression
Enrollment 96 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov