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

NCT07027761 | Not Yet Recruiting

• 2 other identifiers: S64351C24M/22/054
• Study Type: interventional
• Target: 210
• Locations: 1 country
• Sites: 1

Brief 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

Keywords

Perinatal depression; maternal mental health; face-to-face intervention; online self-help; early intervention, brief psychotherapy; psychodynamic therapy.

Outcome Measures

Primary Outcomes (1)

• Changes in perinatal depressive symptoms, as measured by the Edinburgh (Postnatal) Depression Scale (E(P)DS), from baseline to end-of-treatment (EOT).

  Severity of perinatal depression as measured by the E(P)DS (Cox et al., 1987)(range 0 - 30, with higher scores reflecting worse outcome).

  EOT (i.e., at 3 months postpartum)

Secondary Outcomes (6)

• Changes in perinatal depressive symptoms, as measured by the Edinburgh (Postnatal) Depression Scale (E(P)DS), from baseline to 12-months follow-up

  12 months follow-up

• Parental stress, as measured by the Parental Stress Scale (PSS), at EOT and 12-months follow-up;

  EOT (i.e., at 3 months postpartum) and 12-months follow-up

• Changes in mother-infant bonding, as measured by the Maternal Postnatal Attachment Scale (MPAS), from baseline to EOT and 12-months follow-up

  EOT (i.e., at 3 months postpartum) and 12-month follow-up

• Child socio-emotional development, as measured by the Ages & Stages Questionnaire - Social-Emotional (ASQ:SE-2), at EOT and 12-months follow-up

  EOT (i.e., at 3 months postpartum) and 12-months follow-up

• Coparenting, as measured by the Coparenting Relationship Scale (CRS; Feinberg et al., 2012), at baseline, EOT and 12 months follow-up. The CRS assesses parents' perceptions of their coparenting relationship.

  EOT (i.e., at 3 months postpartum) and 12 months follow-up

Other Outcomes (8)

• Cost-effectiveness, as measured by the Treatment Inventory of Costs in Patients with psychiatric disorder (TIC-P), from baseline to EOT, 6- and 12-months follow-up

  EOT (i.e., at 3 months postpartum), 6- and 12-months follow-up

• Feasibility (1)

  Baseline

• Feasibility (2)

  EOT (i.e., at 3-months post-partum)

Study Arms (3)

Online self-help

ACTIVE COMPARATOR

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/).

Behavioral: Online self-help

Maternal Mental Health Intervention (MaMHI)

ACTIVE COMPARATOR

A brief, eight-session face-to-face intervention designed for (expectant) mothers and their infants across the perinatal period.

Behavioral: Maternal Mental Health Intervention (MaMHI)

Usual care

OTHER

Usual care offered to (expectant) mothers in Flanders, Belgium

Other: Usual Care

Interventions

Online self-help BEHAVIORAL

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.

Online self-help

Maternal Mental Health Intervention (MaMHI) BEHAVIORAL

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

Maternal Mental Health Intervention (MaMHI)

Usual Care OTHER

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.

Usual care

Eligibility Criteria

• Age: 16 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• Participants will be drawn from the broader PRIL (Perinatal mental health Profiling and Intervention in Leuven) study, who consented to being contacted for the intervention trial and who meet criteria for moderate risk for perinatal depression based on an analytical epidemiological approach aligned with precision medicine principles, specifically a concentration-of-risk prediction modeling approach. Based on a comprehensive assessment of biological, psychological and social risk and protective factors, concentration-of-risk models will be developed and validated to stratify respondents in terms of risk for future perinatal depression, namely (1) not, (2) mildly, (3) moderately and (4) highly at risk of developing perinatal depression. Mothers falling into the moderate risk profile are eligible to participate

You may not qualify if:

• Receiving concurrent psychological guidance in perinatal mental health problems;
• Not consenting to (a) audiorecording of the first two face-to-face sessions and/or (b) paying the appropriate fee, in case of randomization to the face-to-face intervention arm.

Sponsors & Collaborators

• Universitaire Ziekenhuizen KU Leuven: lead
• Erasmus University Rotterdam: collaborator

Study Sites (1)

Obstetric outpatient clinic, UZ Leuven

Leuven, 3000, Belgium

Location

Study Officials

• Patrick Luyten, PhD

  University of Leuven

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Lien Mutsaerts, MSc

CONTACT

+32 16 37 30 05; lien.mutsaerts@kuleuven.be

Eileen Tang, PhD

CONTACT

+32 16 37 76 85; Eileen.Tang@kuleuven.be

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Full Professor of Clinical Psychology, KU Leuven, Belgium

Model Details: A single-site, assessor-blinded, combined superiority and non-inferiority randomized controlled trial comparing an online self-help intervention (+ usual care) and a brief face-to-face intervention (+ usual care) with usual care in mothers at moderate risk for perinatal depression.

Study Record Dates

• First Submitted: June 2, 2025
• First Posted: June 18, 2025
• Study Start: June 15, 2025
• Primary Completion (Estimated): February 1, 2028
• Study Completion (Estimated): October 31, 2028
• Last Updated: June 18, 2025

Record last verified: 2025-06

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, ICF
• Time Frame: After the publication of results focusing on primary and secondary outcomes/endpoints, anonymized data will be made available to researchers who provide a methodologically sound proposal within a reasonable time frame.

Locations

BE (1)