Psychoeducational intervention for new mothers to prevent postpartum depression and anxiety
Official title: Adaptation and Implementation of a Psychoeducational Intervention to Prevent Postpartum Depression and Anxiety Disorders in New Mothers
Run by Fundacion Clinic per a la Recerca Biomédica · NCT06512025 · Data updated 2026-11-12
This study is testing a new support program for new mothers to see if it can help prevent postpartum depression and anxiety better than regular check-ups.
Quick facts
| Study type | Interventional |
|---|---|
| Ages | 18 Years and up |
| Sex | Women only |
| Enrollment | 400 (estimated) |
| Sponsor | Fundacion Clinic per a la Recerca Biomédica Academic / other |
| Locations | 2 sites (Barcelona, Barcelona and 1 other locations) |
| Status | Recruiting |
| Started | November 8, 2024 |
| Main results expected | June 2027 |
| Study ends | June 2027 |
| Registry record updated | February 26, 2025 |
| Trial ID | NCT06512025 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Ideal candidates are primiparous women who have given birth to a healthy, full-term baby within the last two weeks and are receiving postpartum healthcare.
✕Probably not a fit
Patients who are unable to complete the questionnaires due to language or literacy barriers may not benefit from this study.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
What this trial studies
This clinical trial aims to implement and evaluate the effectiveness of the culturally adapted 'What Were We Thinking (WWWT)' psychoeducational intervention in primary care settings for new mothers. It compares the standard postnatal care with the intervention that includes two additional psychoeducational sessions. The study will assess both the clinical outcomes in terms of postpartum depression and anxiety, as well as the acceptability and accessibility of the intervention for families and healthcare professionals. Participants will complete baseline questionnaires and receive either usual care or the intervention.
Why it matters
Potential benefit: If successful, this intervention could significantly reduce the prevalence of postpartum depression and anxiety among new mothers.
How similar studies have gone: Other studies have shown success with psychoeducational interventions in preventing postpartum mental health issues, indicating a promising approach.
Who can join: the full rules
Show full inclusion / exclusion 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
Where it's running
-
Atenció a la salut sexual i reproductiva (ASSIR) de l'Àrea Integral de Salut Barcelona Esquerra (AIS-BE)
Barcelona, Barcelona, Spain Recruiting -
Unitat de Salut Mental Perinatal (USMP) de l'Hospital Clínic de Barcelona
Barcelona, Barcelona, Spain Not yet recruiting
Study contacts
- Principal investigator: Alba Roca, Doctor — Fundacion Clinic per a la Recerca Biomédica
- Study coordinator: Alba Roca, Doctor
- Email: aroca1@clinic.cat
- Phone: +34653092959
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How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.