Clinical Research Directory

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

Sponsor: Universitaire Ziekenhuizen KU Leuven

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.

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.

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