Clinical trial NCT06512025: Implementation of a Psychoeducational Intervention in New Mothers
Official title: Adaptation and Implementation of a Psychoeducational Intervention to Prevent Postpartum Depression and Anxiety Disorders in New Mothers
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Depression, Postpartum
Anxiety
Keywords: Postpartum Period
Prevention
Preventive Health Care
Psychoeducation
Primiparity
Female
Lead sponsor: Fundacion Clinic per a la Recerca Biomédica
Sponsor class: OTHER
Collaborators: name: Fundació La Marató de TV3
name: Fundacio d'Investigacio en Atencio Primaria Jordi Gol i Gurina
name: Universitat Autonoma de Barcelona
First posted: 2024-07-22
Enrollment: 400
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: PARALLEL
Intervention model description: A CONSORT-compliant parallel group randomized controlled trial will be conducted
Primary purpose: PREVENTION

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

Primary outcomes:
measure: Mental Disorders
timeFrame: 3 and 6 months postpartum (follow-up)
measure: Depressive symptoms
timeFrame: Baseline, 3 and 6 months follow-up
measure: Depressive symptoms
timeFrame: Baseline, 3 and 6 months follow-up
measure: Anxiety symptoms
timeFrame: Baseline, 3 and 6 months follow-up
Secondary outcomes:
measure: Maternal postpartum bonding
timeFrame: Baseline, 3 and 6 months follow-up
measure: Parenting self-regulation
timeFrame: Baseline, 3 and 6 months follow-up
measure: Marital Adjustment
timeFrame: Baseline, 3 and 6 months follow-up
measure: Satisfaction survey
timeFrame: Intervention group participants immediately after completing the WWWT psychoeducative group.
Other outcomes:
measure: Partner Violence
timeFrame: Baseline, 3 and 6 months follow-up
measure: Alcohol use
timeFrame: Baseline, 3 and 6 months follow-up
measure: Childhood trauma
timeFrame: Baseline
measure: Vulnerable Personality Style
timeFrame: Baseline
measure: Perceived Social Support
timeFrame: Baseline, 3 and 6 months follow-up
measure: Sociodemographic variables
timeFrame: Baseline
measure: Psychiatric history, clinical and health variables
timeFrame: Baseline
measure: Obstetrical and neonatal outcomes
timeFrame: Baseline
measure: Baby's temperament
timeFrame: Baseline, 3 and 6 months follow-up
Locations:
city: Barcelona
country: Spain
facility: Unitat de Salut Mental Perinatal (USMP) de l'Hospital Clínic de Barcelona
city: Barcelona
country: Spain
facility: Atenció a la salut sexual i reproductiva (ASSIR) de l'Àrea Integral de Salut Barcelona Esquerra (AIS-BE)
Study officials:
affiliation: Fundacion Clinic per a la Recerca Biomédica
name: Alba Roca, Doctor
role: PRINCIPAL_INVESTIGATOR
References: