NCT06512025

Implementation of a Psychoeducational Intervention in New Mothers

Adaptation and Implementation of a Psychoeducational Intervention to Prevent Postpartum Depression and Anxiety Disorders in New Mothers

• Status: Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 400 (estimated)
• Sponsor: Alba Roca · Academic / Other
• Sex: Female
• Age: 18 Years
• Healthy volunteers: Not accepted

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)

Conditions

• Depression, Postpartum
• Anxiety

Interventions

Type	Name	Description
BEHAVIORAL	WWWT psychoeducative intervention	"What Were We Thinking" (WWWT) is a highly structured, interactive, gender-informed, couples-based, psycho-educational program for parents and a first newborn to promote confident parental caretaking, optimize functioning in the intimate partner relationship and improve infant care manageability. The adaptation of the WWWT programme (Catalan and Spanish version) comprises 2 sessions, each lasting 2 hours, that will be designed for groups of 5-7 families - within the first 6 weeks postpartum -, each consisting of mother, partner (or other caregiver) and their infant(s).

Timeline

• Start date: 2024-11-08
• Primary completion: 2027-06-01
• Completion: 2027-06-01
• First posted: 2024-07-22
• Last updated: 2025-02-26

Locations

2 sites across 1 country: Spain