NCT06640907 Feasibility Study and Pilot Hybrid Effectiveness-Implementation Trial for the Universal Prevention of Maternal Perinatal Mental Disorders as Normalized Routine Practice (e-Perinatal Pilot)
| NCT ID | NCT06640907 |
| Status | Recruiting |
| Phase | — |
| Sponsor | University of Seville |
| Condition | Perinatal Depression |
| Study Type | INTERVENTIONAL |
| Enrollment | 96 participants |
| Start Date | 2025-05-02 |
| Primary Completion | 2025-12 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 96 participants in total. It began in 2025-05-02 with a primary completion date of 2025-12.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
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.
Eligibility Criteria
Inclusion criteria for mothers: * Must receive an invitation to participate from a healthcare professional at one of the participating primary healthcare centers * Must be pregnant for at least 16 weeks or have given birth within the last 5 months 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 Inclusion criteria for 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 for mothers: * Meet diagnostic criteria for anxiety or depression, as determined by a structured clinical interview * Be on a waiting list or currently receiving psychological or pharmacological treatment for any mental health or substance use condition Exclusion criteria for partners (or significant others): * There are no exclusion criteria for partners
Contact & Investigator
Frequently Asked Questions
Who can join the NCT06640907 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying Perinatal Depression. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT06640907 currently recruiting?
Yes, NCT06640907 is actively recruiting participants. Contact the research team at eperinatal@us.es for enrollment information.
Where is the NCT06640907 trial being conducted?
This trial is being conducted at Mairena del Aljarafe, Spain.
Who is sponsoring the NCT06640907 clinical trial?
NCT06640907 is sponsored by University of Seville. The trial plans to enroll 96 participants.
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