A Chat-bot Based Version of the WHO-validated Intervention Self-Help+ for Stress Management in Pregnant Women: Protocol for a Pilot Feasibility Study (Preprint)

BACKGROUND Pregnancy is a multifaceted period marked by significant changes in a woman's life, influencing her physical, mental, and social dimensions. The way a woman navigates these transformations can significantly impact her overall well-being and psychological health. The existing literature underscores the prevalence of various psychological symptoms among pregnant women, with anxiety, stress, and depression being the most frequently reported. Prioritising a healthy lifestyle that specifically addresses a woman's psychological welfare is paramount. In this context, emerging digital solutions play a pivotal role in bolstering the psychological well-being of expectant mothers with no underlying psychological or psychiatric disorders. The development and implementation of such digital tools, such as a virtual coach integrated into a smartphone, have become increasingly evident as valuable resources to support the mental health of physiologically pregnant women. OBJECTIVE Our objective was to assess the feasibility, acceptability, and utility of an ACT-based stress management mobile app. The primary objective of the present research is to explore the feasibility of using a virtual coach, ALBA, developed within the Trec Ricerca App to promote women's psychological well-being during pregnancy through five sessions based on ACT. Finally, through the delivery of this intervention, the level of psychological well-being will be explored as a secondary objective. METHODS The current study serves as a proof-of-concept investigation, where a small sample size (N=50) is deemed adequate to fulfil the study's objectives. Participant recruitment will be conducted among pregnant women affiliated with the pregnancy care services of the Azienda Provinciale per i Servizi Sanitari di Trento, utilising a convenience sampling approach. ALBA will interact with the participating women for 6 weeks, starting from weeks 14 and 26 of pregnancy. Specifically, there will be one session per week, which the woman can choose, to allow more flexibility toward her needs, supplemented by ALBA-supported exercises to be performed between sessions. RESULTS The psychoeducational approach aims to yield notable outcomes regarding the usability and engagement of women with ALBA. Furthermore, an anticipated enhancement in psychological well-being and quality of life is expected. The analysis of the data gathered in this study will primarily adopt a descriptive perspective, focused on evaluating the attainment of the study objectives. CONCLUSIONS Existing literature indicates a preference among women in the perinatal period for online support, highlighting the potential of digital interventions to address barriers related to social stigma and seeking assistance. In this context, ALBA emerges as a valuable resource, providing consistent psychoeducational support for women throughout the course of pregnancy. CLINICALTRIAL This study was approved by the ethics committee of the APSS (Provincial Health Services Authority) under number 17241 (July 17, 2024)