Psychoeducational intervention for new mothers to prevent postpartum depression and anxiety
Adaptation and Implementation of a Psychoeducational Intervention to Prevent Postpartum Depression and Anxiety Disorders in New Mothers
NA · Fundacion Clinic per a la Recerca Biomédica · NCT06512025
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
| Phase | NA |
|---|---|
| Study type | Interventional |
| Enrollment | 400 (estimated) |
| Ages | 18 Years and up |
| Sex | Female |
| Sponsor | Fundacion Clinic per a la Recerca Biomédica (other) |
| Locations | 2 sites (Barcelona, Barcelona and 1 other locations) |
| Trial ID | NCT06512025 on ClinicalTrials.gov |
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.
Who should consider this trial
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.
Not a fit: Patients who are unable to complete the questionnaires due to language or literacy barriers may not benefit from this study.
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 performed: Other studies have shown success with psychoeducational interventions in preventing postpartum mental health issues, indicating a promising approach.
Eligibility criteria
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 this trial is running
Barcelona, Barcelona and 1 other locations
- Unitat de Salut Mental Perinatal (USMP) de l'Hospital Clínic de Barcelona — Barcelona, Barcelona, Spain (NOT_YET_RECRUITING)
- Atenció a la salut sexual i reproductiva (ASSIR) de l'Àrea Integral de Salut Barcelona Esquerra (AIS-BE) — Barcelona, Barcelona, Spain (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
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
Conditions: Depression, Postpartum, Anxiety, Postpartum Period, Prevention, Preventive Health Care, Psychoeducation, Primiparity, Female