NCT06512025 Implementation of a Psychoeducational Intervention in New Mothers
| NCT ID | NCT06512025 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Alba Roca |
| Condition | Depression, Postpartum |
| Study Type | INTERVENTIONAL |
| Enrollment | 400 participants |
| Start Date | 2024-11-08 |
| Primary Completion | 2027-06 |
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 400 participants in total. It began in 2024-11-08 with a primary completion date of 2027-06.
⚠ 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
The goal of this clinical trial is to implement and examine the clinical effectiveness in a randomized study of the Catalan and Spanish versions of the culturally adapted "What Were We Thinking (WWWT)" psychoeducational intervention in primary care services, with the aim of preventing and reducing the prevalence of postpartum mental illness in new mothers. Additionally, the trial will assess the acceptability and accessibility of the intervention by families and professionals. Researchers will compare "Usual Care" (standard postnatal care provided by professionals from the Sexual and Reproductive Health Service) with "Intervention group" (usual care plus two psychoeducative intervention WWWT sessions) to see if the "WWWT intervention" is better than "Usual Care" at preventing postpartum depression and anxiety disorders in new mothers. Participants will: * Take baseline questionnaires at 2-4 weeks postpartum * Take usual care or usual care plus two psychoeducative intervention WWWT sessions within the first 6 weeks postpartum * Take the same questionnaires used in baseline plus a semi-structured interview to diagnose major mental disorder (all participants) at 3 and 6 months follow-up * Take a brief anonymous self-report survey (only those participants taking the WWWT intervention)
Eligibility Criteria
Inclusion Criteria: * Primiparous women * Given birth a healthy, full-term baby in the preceding 2 weeks * Receiving postpartum healthcare at Atenció a la salut sexual i reproductiva (ASSIR) of Àrea Integral de Salut Barcelona Esquerra (AIS-BE) * Over 18 years of age * Give consent to participate in the study Exclusion Criteria: * If are unable to complete the questionnaires due to language or literacy barriers
Contact & Investigator
Alba Roca, Doctor
PRINCIPAL INVESTIGATOR
Fundacion Clinic per a la Recerca Biomédica
Frequently Asked Questions
Who can join the NCT06512025 clinical trial?
This trial is open to female participants only, aged 18 Years or older, studying Depression, Postpartum. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT06512025 currently recruiting?
Yes, NCT06512025 is actively recruiting participants. Contact the research team at aroca1@clinic.cat for enrollment information.
Where is the NCT06512025 trial being conducted?
This trial is being conducted at Barcelona, Spain, Barcelona, Spain.
Who is sponsoring the NCT06512025 clinical trial?
NCT06512025 is sponsored by Alba Roca. The principal investigator is Alba Roca, Doctor at Fundacion Clinic per a la Recerca Biomédica. The trial plans to enroll 400 participants.
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