Clinical trial 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
Official title: Maternal Mental Health Intervention (MaMHI) Study: A Combined Non-inferiority and Superiority Randomized Controlled Trial Comparing the Clinical and Cost-effectiveness of an Online Self-help Intervention and a Brief Face-to-face Intervention Versus Usual Care in Mothers at Moderate Risk for Perinatal Depression Identified by a Concentration-of-risk Prediction Approach.
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Perinatal Depression
Keywords: Perinatal depression; maternal mental health; face-to-face intervention; online self-help; early intervention, brief psychotherapy; psychodynamic therapy.
Lead sponsor: Universitaire Ziekenhuizen KU Leuven
Sponsor class: OTHER
Collaborators: name: Erasmus University Rotterdam
First posted: 2025-06-18
Enrollment: 210
Sex: FEMALE
Minimum age (years): 16
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: 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.
Primary purpose: TREATMENT

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.

Detailed description: Introduction The perinatal period, encompassing pregnancy and the first year postpartum (O'Hara \& Wisner, 2014), represents a time of significant physiological, psychological and social change, necessitating considerable adaptation by expectant parents (Milgrom \& Gemmill, 2015). This transitional phase is characterized by a coexistence of intense positive emotions-such as joy, hope, and excitement-and challenging negative emotions, including insecurity, anxiety and depression. As a result, both the transition to parenthood and the early stages of parenting are associated with increased vulnerability to emotional difficulties.

Mental health problems are highly prevalent in the perinatal period, affecting approximately one in five expectant or new mothers (Van Damme et al., 2018). Among these, perinatal depression (PD)-which includes both minor and major depressive episodes-is one of the most common complications during pregnancy and postpartum (Wisner et al., 2013). The point prevalence of major depressive disorder during pregnancy ranges from 3.1% to 4.9%, increasing to approximately 5% in the first three months postpartum. Minor depression affects an estimated 11% of pregnant women and 13% of women in the first three months after childbirth. The period prevalence of any depression during pregnancy and the first three postpartum months is estimated at 18.4% and 19.2%, respectively, with 12.7% and 7.1% meeting criteria for major depression during those timeframes (Gavin et al., 2005). Notably, one-third of postpartum depression cases begin during pregnancy, and 27% have onset prior to pregnancy (Wisner et al., 2013). Depression during the second and third trimesters increases the likelihood of postpartum depression by factors of 3.2 and 6.6, respectively (Heron et al., 2004). Mental health disturbances during pregnancy are therefore strong predictors of postpartum mental health status (Robertson et al., 2004).

Although most women recover from postnatal depression within a few months, approximately 30% remain clinically depressed beyond the first postpartum year (Goodman, 2004), and 40% may develop a chronic depressive disorder (Vliegen et al., 2014).

The consequences of perinatal depression extend beyond the individual, significantly affecting the mother-infant relationship and the child's socio-emotional development (Atif et al., 2015). For instance, the perinatal period is critical for the establishment of a secure attachment, which is fundamental to a mother's capacity to recognize and respond to her infant's emotional cues (Rosenboom, 2018). Maternal mental health issues may interfere with mothers' emotional availability and responsiveness, which may in turn compromise children's development.

Consistent with these assumptions, epidemiological and longitudinal studies have demonstrated that children of parents with depression have significantly elevated risks of developing depression themselves (Rosenboom, 2018). For example, Weissman et al. (2006) found that offspring of depressed parents were three to four times more likely to develop depression compared to children of non-depressed parents, with up to 50% affected by age 20.

Perinatal mental health (PMH) problems are associated with a high socio-economic burden. According to a UK report by Bauer et al. (2015), the annual cost of PMH problems in the United Kingdom was estimated at £8.1 billion per birth cohort, with 72% of this cost attributed to adverse impacts on child development (Sutter-Dallay et al., 2016). Early identification and intervention are therefore critical for reducing both the prevalence and economic burden of PMH issues (Sutter-Dallay et al., 2016).

Despite robust evidence on the impact of PD and broader PMH disorders on maternal, infant and family well-being, early detection and prevention remain problematic. Approximately 75% of women experiencing perinatal anxiety or depression go undiagnosed, and only about 10% of expectant and new mothers receive adequate treatment (Kingston et al., 2015). In this context, brief and low-intensity interventions show promise, with meta-analytic evidence supporting the efficacy of brief (preventative) interventions, including digital formats (Loughnan et al., 2019).

However, access to these interventions is often restricted to individuals with subthreshold symptoms or those highly motivated to seek care. Interventions that match the risk status of individuals may be more effective than a 'one-size-fits-all' approach. For instance, for women with more complex and persistent depression, targeted intensive approaches may be most effective (Howard \& Khalifeh, 2020). Women with less severe clinical presentations may respond well to brief, scalable interventions, including online self-help programs and brief face-to-face (FTF) psychological interventions (Loughnan et al., 2019), and these interventions may also be cost-effective.

The present study This study will be the first to evaluate the clinical and cost-effectiveness of an online self-help intervention compared to a brief 8-session FTF intervention, both offered alongside usual care, for pregnant women at moderate risk for developing PD based on an analytical epidemiological approach aligned with precision medicine principles relying on a concentration-of-risk prediction modeling approach.

The primary aim of this study is to assess whether an online self-help program and a brief FTF intervention, in conjunction with usual care, is superior to usual care alone in reducing severity of depression from baseline to end-of-treatment (primary outcome). It is hypothesized that both interventions will be superior to usual care and that online self-help is non-inferior to the brief FTF intervention.

Secondary aims are to assess whether online self-help and brief FTF intervention are more effective than usual care in reducing parental stress, and in fostering mother-infant bonding, child socio-emotional development, and quality of life (secondary outcomes).

In addition, treatment credibility and expectancy of and satisfaction with the three treatments will be investigated, as well as their cost-effectiveness.

A qualitative study will be embedded within the trial to investigate mothers' experience of the brief FTF intervention.

References

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Eligibility criteria: Inclusion Criteria:

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

Exclusion Criteria:

* 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.

Primary outcomes:
measure: Changes in perinatal depressive symptoms, as measured by the Edinburgh (Postnatal) Depression Scale (E(P)DS), from baseline to end-of-treatment (EOT).
timeFrame: EOT (i.e., at 3 months postpartum)
Secondary outcomes:
measure: Changes in perinatal depressive symptoms, as measured by the Edinburgh (Postnatal) Depression Scale (E(P)DS), from baseline to 12-months follow-up
timeFrame: 12 months follow-up
measure: Parental stress, as measured by the Parental Stress Scale (PSS), at EOT and 12-months follow-up;
timeFrame: EOT (i.e., at 3 months postpartum) and 12-months follow-up
measure: Changes in mother-infant bonding, as measured by the Maternal Postnatal Attachment Scale (MPAS), from baseline to EOT and 12-months follow-up
timeFrame: EOT (i.e., at 3 months postpartum) and 12-month follow-up
measure: Child socio-emotional development, as measured by the Ages & Stages Questionnaire - Social-Emotional (ASQ:SE-2), at EOT and 12-months follow-up
timeFrame: EOT (i.e., at 3 months postpartum) and 12-months follow-up
measure: 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.
timeFrame: EOT (i.e., at 3 months postpartum) and 12 months follow-up
measure: Changes in quality of life, as measured by the EuroQol-5D-5L (EQ-5D-5L), from baseline to EOT and 12-months follow-up;
timeFrame: EOT (i.e., at 3 months postpartum) and 12-months follow-up
Other outcomes:
measure: 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
timeFrame: EOT (i.e., at 3 months postpartum), 6- and 12-months follow-up
measure: Feasibility (1)
timeFrame: Baseline
measure: Feasibility (2)
timeFrame: EOT (i.e., at 3-months post-partum)
measure: Feasibility (3)
timeFrame: 12-months follow-up
measure: Acceptability (1)
timeFrame: EOT (i.e., at 3-months post-partum)
measure: Acceptability (2)
timeFrame: Baseline
measure: Acceptability (3)
timeFrame: Baseline, EOT (i.e., 3-months postpartum), 12 months-follow-up
measure: Acceptability (4)
timeFrame: EOT (i.e., at months post-partum) and 12 months follow-up
Locations:
city: Leuven
country: Belgium
facility: Obstetric outpatient clinic, UZ Leuven
Study officials:
affiliation: University of Leuven
name: Patrick Luyten, PhD
role: PRINCIPAL_INVESTIGATOR
References: