A Mindfulness-Based App Intervention for Pregnant Women: Protocol for a Pilot Feasibility Study

Background: Pregnancy is a complex time characterised by major transformations in the woman, which impact her physical, mental, and social well-being. How a woman adapts to these changes can affect her quality of life and psychological well-being. Indeed, the literature reports how pregnant women experience various psychological symptoms, the most frequent and common of which are symptoms of anxiety, stress, and/or depression. Indeed, promoting a healthy lifestyle focused on a woman's psychological well-being is crucial. Recently developed digital solutions have assumed a crucial role in supporting psychological well-being in physiologically pregnant women. Therefore, the development and implementation of digital solutions, such as a virtual coach implemented in a smartphone, as a support for the psychological well-being of pregnant women who do not present psychological/psychiatric disorders becomes evident. Objective: Our objective was to assess a mindfulness-based mobile app's feasibility, acceptability, and utility. The primary objective of the present research is to explore the feasibility of using a virtual coach, Maia, developed within the Trec Mamma app to promote women's psychological well-being during pregnancy through a psychoeducational module based on mindfulness. Finally, through the delivery of this module, the level of psychological well-being will be explored as a secondary objective. Methods: The present research is a proof-of-concept study in which a small sample is sufficient to achieve the intended purposes (N=50). Recruitment will occur within the group of pregnant women belonging to the Pregnancy Care Services of the Trento APSS, and the sampling will be convenience sampling. Maia will interact with women for eight weeks, starting from weeks 24/26 of pregnancy. Specifically, there are two sessions per week, which the woman can choose to allow more flexibility towards her needs. Results: The psychoeducational pathway is hoped to lead to significant results in terms of usability and engagement in interaction with Maia by women. In addition, there is expected to be an increase in psychological well-being and quality of life. The analysis of the data collected in the present study will be mainly descriptive, oriented toward assessing the achievement of the study objectives. Conclusions: Literature has shown that women during the perinatal period preferred online support, suggesting that implementing digital interventions can overcome barriers to social stigma and asking for help. Maia can be a valuable resource for regular psycho-educational support for women during pregnancy. Clinicaltrial: This study was approved by the ethics committee of the APSS (Provincial Health Services Authority) under number 15742 of 14/09/2023.