Background: Pregnancy is a complex period involving significant physical, mental, and social changes in a woman's life, affecting her psychological well-being. According to the literature, anxiety, stress, and depression are common symptoms among pregnant women. Promoting a healthy lifestyle with a focus on mental health is essential. In this context, digital solutions like virtual coaches on smartphones are emerging as valuable tools to support the psychological well-being of pregnant women without pre-existing disorders. Objective: The aim of this paper is to present the research protocol of a pilot study designed as a proof-of-concept investigation. The study evaluates 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. The pre-post intervention of psychological well-being will also be explored as a secondary objective as a proxy of potential impact of the intervention. Methods: The 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. This study adopts a mixed-methods approach, combining quantitative and qualitative data collection and analysis. Usability and engagement are assessed using the System Usability Scale, Chatbot Usability Questionnaire, User Engagement Scale-Short Form, and the User Mobile Application Rating Scale. Moreover, other quantitative outcome measures include levels of stress, anxiety and depression, emotional regulation, psychological flexibility, coping strategies, self-efficacy, and overall well-being and qualitative data from semi-structured interviews. Finally the analysis of the data gathered in this study will primarily adopt descriptive statistics and text mining approach, focused on evaluating the attainment of the study objectives and changes over experimental time. 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. 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.
A Chat-bot Based Version of the WHO-validated Intervention Self-Help+ for Stress Management in Pregnant Women: Protocol for a Usability Study
Purgato, Marianna;Barbui, Corrado;
2025-01-01
Abstract
Background: Pregnancy is a complex period involving significant physical, mental, and social changes in a woman's life, affecting her psychological well-being. According to the literature, anxiety, stress, and depression are common symptoms among pregnant women. Promoting a healthy lifestyle with a focus on mental health is essential. In this context, digital solutions like virtual coaches on smartphones are emerging as valuable tools to support the psychological well-being of pregnant women without pre-existing disorders. Objective: The aim of this paper is to present the research protocol of a pilot study designed as a proof-of-concept investigation. The study evaluates 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. The pre-post intervention of psychological well-being will also be explored as a secondary objective as a proxy of potential impact of the intervention. Methods: The 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. This study adopts a mixed-methods approach, combining quantitative and qualitative data collection and analysis. Usability and engagement are assessed using the System Usability Scale, Chatbot Usability Questionnaire, User Engagement Scale-Short Form, and the User Mobile Application Rating Scale. Moreover, other quantitative outcome measures include levels of stress, anxiety and depression, emotional regulation, psychological flexibility, coping strategies, self-efficacy, and overall well-being and qualitative data from semi-structured interviews. Finally the analysis of the data gathered in this study will primarily adopt descriptive statistics and text mining approach, focused on evaluating the attainment of the study objectives and changes over experimental time. 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. 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.
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