Implementation of a Psychoeducational Intervention in New Mothers (EQEP)

Alba Roca

Status: Enrolling

Conditions: Depression, Postpartum; Anxiety

Treatments: Behavioral: WWWT psychoeducative intervention

Study type: Interventional

Funder types: Other

Identifiers

NCT06512025

193/C/2022

Details and patient eligibility

About

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)

Enrollment: 400 estimated patients

Sex: Female

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Prevention

Allocation: N/A

Interventional model: Parallel Assignment

Masking: Single Blind

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400 participants in 2 patient groups

Usual Care

No Intervention group

Description:

Participants will received the postpartum usual care at the Sexual and Reproductive Health Service (ASSIR).

WWWT psychoeducative intervention

Experimental group

Description:

Participants will received the postpartum routine usual care plus two psychoeducative intervention WWWT sessions at the Sexual and Reproductive Health Service (ASSIR).

Treatment:

Behavioral: WWWT psychoeducative intervention