Clinical and Cost-effectiveness of an Online Self-help Intervention and a Face-to-face Intervention Versus Usual Care in Mothers at Moderate Risk for Perinatal Depression

NANot yet recruitingINTERVENTIONAL
Enrollment

210

Participants

Timeline

Start Date

June 15, 2025

Primary Completion Date

February 1, 2028

Study Completion Date

October 31, 2028

Conditions
Perinatal Depression
Interventions
BEHAVIORAL

Online self-help

Online Self-Help refers to a 24/7 accessible, internet-based platform that offers digital modules grounded in evidence-based approaches, including infant mental health, cognitive-behavioral therapy (CBT), and psychodynamic interventions, aimed at addressing perinatal depression (https://perinatalehulp.be/). Upon logging in, participants receive an overview of the available modules and can select from three distinct treatment trajectories, ideally to be completed over the course of 10 weeks: (a) a self-directed option allowing free choice among all modules; (b) a structured CBT trajectory incorporating both second-wave and third-wave cognitive-behavioral strategies; or (c) a psychodynamic trajectory primarily focused on relational and attachment-related factors contributing to the onset and maintenance of perinatal depression.

BEHAVIORAL

Maternal Mental Health Intervention (MaMHI)

A brief, eight-session face-to-face intervention designed for (expectant) mothers and their infants across the perinatal period, consisting of four prenatal sessions (during the second and third trimesters of pregnancy) and four postnatal sessions conducted within the first three months postpartum. The intervention is grounded in psychodynamic principles and informed by mentalization-based approaches

OTHER

Usual Care

Prenatal care is provided through follow-up by a general practitioner and a gynecologist and/or a midwife, while postnatal follow-up is conducted by Child and Family Care Services.

Trial Locations (1)

3000

Obstetric outpatient clinic, UZ Leuven, Leuven

All Listed Sponsors
collaborator

Erasmus University Rotterdam

OTHER

lead

Universitaire Ziekenhuizen KU Leuven

OTHER

NCT07027761 - Clinical and Cost-effectiveness of an Online Self-help Intervention and a Face-to-face Intervention Versus Usual Care in Mothers at Moderate Risk for Perinatal Depression | Biotech Hunter | Biotech Hunter