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

Summary

The perinatal period (pregnancy and the first postnatal year) (O'Hara \& Wisner, 2014) involves important changes and considerable challenges for parents (Milgrom \& Gemmill, 2015). As a result, perinatal mental health (PMH) disorders are highly prevalent. It is estimated that 1 in 5 women meet criteria for mental health disorders during the perinatal period (Van Damme et al., 2018). These psychological problems not only significantly impact (expectant) mother's own wellbeing, but also that of their children, partners, and their support networks. Additionally, PMH problems are associated with significant financial burden. For instance, In the UK perinatal depression and anxiety are estimated to cost approximately £8.1 billion per annual birth cohort (Bauer, 2015). Prevention of these problems is therefore essential. Unfortunately, in up to 75% of women symptoms of depressive or anxiety disorders are not detected timely, and only 10% of these women receive appropriate help (Kingston et al., 2015).

This study proposes a novel approach to intervention by investigating the effectiveness of psychosocial treatments for (expectant) mothers identified to be at moderate risk of developing perinatal depression based on a novel statistical risk modeling approach. Specifically, we will investigate the clinical and cost-effectiveness of (a) an online self-help program and (b) a brief face-to-face (FTF) intervention for expectant mothers with a moderate risk of developing perinatal depression, compared to (c) standard care (treatment as usual). We expect both active treatments to be superior compared to standard care and similar in effectiveness to each other. In addition, we expect both online self-help and the brief FTF intervention to be more cost-effective compared to usual care. Moreover, we will also investigate the effects of the three treatments on a range of other important outcomes, participants' satisfaction with the treatments, the credibility of the treatments and expected effects as rated by patients. Finally, in a small qualitative study, we will investigate the subjective experiences of participants in the brief FTF intervention specifically.

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.

Sponsors & Collaborators

• Erasmus University Rotterdam

  collaborator OTHER

• Universitaire Ziekenhuizen KU Leuven

  lead OTHER

Principal Investigators

• Patrick Luyten, PhD · University of Leuven

Study Design

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

DOUBLE

Model

PARALLEL

Eligibility

Min Age

16 Years

Sex

FEMALE

Healthy Volunteers

No

Timeline & Regulatory

Start

2025-06-15

Primary Completion

2028-02-01

Completion

2028-10-31

Countries

• Belgium

Study Locations