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.
None
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.
Parallel
Online self-help
BehavioralOnline 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.
Maternal Mental Health Intervention (MaMHI)
BehavioralA 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
Usual Care
Other interventionPrenatal 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.
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).
Changes in perinatal depressive symptoms, as measured by the Edinburgh (Postnatal) Depression Scale (E(P)DS), from baseline to 12-months follow-up
Severity of depression as measured by the EPDS (Cox et al., 1987). Scores range from 0 to 30, with higher scores reflecting higher levels of perinatal depression
Parental stress, as measured by the Parental Stress Scale (PSS), at EOT and 12-months follow-up;
Parental stress as measured by the Parental Stress Scale (PSS; Berry \& Jones, 1995). The PSS measures the levels of stress experienced by parents taking into account positive and negative aspects of parenting. Scores range between 18 and 90, with higher scores reflecting higher perceived parental stress
Changes in mother-infant bonding, as measured by the Maternal Postnatal Attachment Scale (MPAS), from baseline to EOT and 12-months follow-up
Mother-infant bonding as measured by the Maternal Postnatal Attachment Scale (MPAS; Condon \& and Corkindale, 1998). The MPAS measures the emotional tie or bond of a mother towards her infant through self-reported feelings, cognitions and behaviors. The scale comprises three subscales: quality of attachment, pleasure in interaction, and absence of hostility. Total scores range between 19 and 95, with higher scores indicating stronger mother-infant bonding. The subscale scores range from 9 to 45 for quality of attachment and 5 to 25 for both pleasure in interaction and absence of hostility
Child socio-emotional development, as measured by the Ages & Stages Questionnaire - Social-Emotional (ASQ:SE-2), at EOT and 12-months follow-up
Child socio-emotional development as measured by the Ages \& Stages Questionnaire - Social-Emotional (ASQ:SE-2; Squires et al., 2015). The ASQ:SE-2 assesses various dimensions of children's social-emotional development, screening for potential delays and identifying children at risk for developmental problems. The questionnaire is completed by the primary caregiver and can be administered to children aged 3 to 66 months, using the version closest to the child's age (available for 6, 12, 18, 24, 30, 36, 48, and 60 months). Parents indicate how often the child exhibits the described behavior: "most of the time" (0 points), "sometimes" (5 points), or "rarely/never" (10 points). Additionally, parents can express concerns about specific behaviors, adding 5 extra points per marked item. Given the age range of our sample, the 6- and 12-month versions are used. Total scores are calculated by summing all item points and expressed concerns, with higher scores indicating lower levels of child
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
Cost-effectiveness, as measured by the Treatment Inventory of Costs in Patients with psychiatric disorder (TIC-P; Bouwmans et al., 2013). The TIC-P measures medical costs and productivity losses associated with psychosocial problems in adults and is designed for use in economic evaluations. The TIC-P is a recall questionnaire, asking respondents to reflect on expenses incurred over the past one to three months.
Feasibility (1)
Feasibility will be investigated in terms of recruitment rate
Feasibility (2)
Feasibility will be investigated in terms of retention in treatment
Feasibility (3)
Feasibility will be investigated in terms of adherence to the protocol.
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Universitaire Ziekenhuizen KU Leuven
Lead sponsor
Erasmus University Rotterdam
Collaborator
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