Background: Advancements in technology offer new opportunities to support vulnerable populations, such as pregnant women and women diagnosed with breast cancer, during physiologically and psychologically stressful periods. Objective: This study aims to adapt and co-design the World Health Organization’s Self-Help Plus intervention into a mobile health intervention for these target groups. Methods: On the basis of the Obesity-Related Behavioral Intervention Trials and Center for eHealth Research and Disease Management models, low-fidelity and high-fidelity prototypes were developed. Prototypes were evaluated by 13 domain experts from diverse sectors and 15 participants from the target groups to assess usability, attractiveness, and functionality through semantic differential scales, the User Version of the Mobile Application Rating Scale questionnaire, and semistructured interviews. Results: Feedback from participants indicated positive perceptions of the mobile health intervention, highlighting its ease of use, appropriate language, and attractive multimedia content. Areas identified for improvement included enhancing user engagement through reminders, monitoring features, and increased personalization. The quality of the content and adherence to initial protocols were positively evaluated. Conclusions: This research provides valuable insights for future studies aiming to enhance the usability, efficacy, and effectiveness of the app, suggesting the potential role of a chatbot-delivered Self-Help Plus intervention as a supportive tool for pregnant women and women with a breast cancer diagnosis.

Journal of Medical Internet Research - International Scientific Journal for Medical Research, Information and Communication on the Internet #Preprint #PeerReviewMe: Warning: This is a unreviewed preprint. Readers are warned that the document has not been peer-reviewed by expert/patient reviewers or an academic editor, may contain misleading claims, and is likely to undergo changes before final publication, if accepted, or may have been rejected/withdrawn. Readers with interest and expertise are encouraged to sign up as peer-reviewer, if the paper is within an open peer-review period. Please cite this preprint only for review purposes or for grant applications and CVs (if you are the author). 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. Expected 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.

Journal of Medical Internet Research - International Scientific Journal for Medical Research, Information and Communication on the Internet #Preprint #PeerReviewMe: Warning: This is a unreviewed preprint. Readers are warned that the document has not been peer-reviewed by expert/patient reviewers or an academic editor, may contain misleading claims, and is likely to undergo changes before final publication, if accepted, or may have been rejected/withdrawn. Readers with interest and expertise are encouraged to sign up as peer-reviewer, if the paper is within an open peer-review period. Please cite this preprint only for review purposes or for grant applications and CVs (if you are the author). 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. Clinical Trial: This study was approved by the ethics committee of the APSS (Provincial Health Services Authority) under number 17241 (July 17, 2024)

Background: Pregnancy is a complex period characterized by significant transformations. How a woman adapts to these changes can affect her quality of life and psychological well-being. Recently developed digital solutions have assumed a crucial role in supporting the psychological well-being of pregnant women. However, these tools have mainly been developed for women who already present clinically relevant psychological symptoms or mental disorders. Objective: This study aimed to develop a mindfulness-based well-being intervention for all pregnant women that can be delivered electronically and guided by an online assistant with wide reach and dissemination. This paper aimed to describe a prototype technology-based mindfulness intervention’s design and development process for pregnant women, including the exploration phase, intervention content development, and iterative software development (including design, development, and formative evaluation of paper and low-fidelity prototypes). Methods: Design and development processes were iterative and performed in close collaboration with key stakeholders (N=15), domain experts including mindfulness experts (n=2), communication experts (n=2), and psychologists (n=3), and target users including pregnant women (n=2), mothers with young children (n=2), and midwives (n=4). User-centered and service design methods, such as interviews and usability testing, were included to ensure user involvement in each phase. Domain experts evaluated a paper prototype, while target users evaluated a low-fidelity prototype. Intervention content was developed by psychologists and mindfulness experts based on the Mindfulness-Based Childbirth and Parenting program and adjusted to an electronic format through multiple iterations with stakeholders. Results: An 8-session intervention in a prototype electronic format using text, audio, video, and images was designed. In general, the prototypes were evaluated positively by the users involved. The questionnaires showed that domain experts, for instance, positively evaluated chatbot-related aspects such as empathy and comprehensibility of the terms used and rated the mindfulness traces present as supportive and functional. The target users found the content interesting and clear. However, both parties regarded the listening as not fully active. In addition, the interviews made it possible to pick up useful suggestions in order to refine the intervention. Domain experts suggested incorporating auditory components alongside textual content or substituting text entirely with auditory or audiovisual formats. Debate surrounded the inclusion of background music in mindfulness exercises, with opinions divided on its potential to either distract or aid in engagement. The target users proposed to supplement the app with some face-to-face meetings at crucial moments of the course, such as the beginning and the end. Conclusions: This study illustrates how user-centered and service designs can be applied to identify and incorporate essential stakeholder aspects in the design and development process. Combined with evidence-based concepts, this process facilitated the development of a mindfulness intervention designed for the end users, in this case, pregnant women.

Background: This paper describes the adaptation of an evidence-based intervention for mental health, Self-Help Plus (SH+), to a digital platform, aiming to expand mental health support through innovative technological solutions. The SH+ intervention, designed by the World Health Organization (WHO), is a low-intensity, self-guided program aimed at improving mental well-being. The intervention has been integrated into a chatbot-driven mobile app called “ALBA” (Automated Well-Being Assistant). Objective: This protocol describes the stages of transition (porting) from a traditional face-to-face, group-based approach to a tech-enabled model, tailored specifically for women with breast cancer and pregnant women. The adaptation of this approach is described, focusing on 2 key aspects: (1) the shift from in-person delivery to a tech-enabled intervention and (2) the customization of the intervention to address the unique needs of the selected target groups. Methods: The development of the ALBA app involved a collaborative, multidisciplinary approach combining expertise in psychology, eHealth IT, interaction design, and specific domain knowledge related to pregnancy and oncology. The development process followed 2 primary methodologies: user-centered design and service design. These approaches emphasize understanding user needs, promoting iterative improvements, and continuously incorporating user feedback. The development followed the Obesity-Related Behavioral Intervention Trials (ORBIT) model, which involves a cycle of literature review, stakeholder consultation, content development, software development, and evaluation. At the same time, specific attention was dedicated to (1) adapting the SH+ protocol to suit the chatbot-driven ALBA platform, (2) tailoring content to the target population, and (3) incorporating interactive features to improve engagement and potential efficacy. Results: The manuscript outlines the key steps and processes involved in adapting the SH+ intervention into the ALBA digital platform. This includes an overview of the challenges and opportunities of translating a face-to-face, group-based intervention into a tech-enabled model and provides insight into how customization for specific populations, such as women with breast cancer and pregnant women, was integrated into the design of the platform. This is in view of informing future studies on the development and adaptation of already validated protocols into mobile health (mHealth) interventions in the field of mental health and mental well-being. Conclusions: The digital adaptation of the SH+ intervention into the ALBA platform could represent a significant step forward in expanding the accessibility and personalization of mental health interventions in potentially different settings and target groups. The use of virtual coaching applications can play a central role in improving the availability and ease of access of psychological support, even in different and mHealth formats. Future developments could include further testing in real-world settings to expand (1) adaptations for various target groups and (2) the purpose of use to range from primary prevention to more clinically focused interventions. International Registered Report Identifier (IRRID): DERR1-10.2196/69644

Background: Emerging digital tools play an innovative and key role in supporting women’s psychological well-being throughout the different stages and challenges of cancer. The development and adoption of digital interventions, including chatbots and virtual coaches within smartphone apps, are increasingly recognized as valuable resources for enhancing women’s mental health. Objective: The aim of this paper is to present the research protocol for a pilot study designed as a proof-of-concept investigation. The study evaluates the feasibility, acceptability, and perceived utility of a mobile app delivering an acceptance and commitment therapy–based stress management intervention. The intervention is delivered through ALBA (A Well-Being Assistant), a virtual coach embedded within the TreC (an acronym for cartella clinica del cittadino, meaning “citizen’s electronic health record”) research platform—a mobile health ecosystem designed to support research and digital health interventions. ALBA guides users through 5 coaching sessions tailored for women undergoing breast cancer (BC) treatment. The chatbot-delivered app is an adaptation of Self-Help Plus, a World Health Organization (WHO)–validated stress management intervention, and is provided in text, audio, and video formats. The intervention’s potential impact on participants’ psychological well-being is also explored. Methods: A convenience sample size of 50 participants will be identified to meet the study’s objectives. Participants will be recruited using a convenience sampling approach from women receiving care at the Breast Unit of the Azienda Provinciale per Servizi Sanitari di Trento. ALBA will interact with the participants for 6 weeks. Specifically, there will be 1 coaching session per week, followed by weekly assigned acceptance and commitment therapy exercises to be performed between sessions. Results: The app is expected to demonstrate high usability and engagement, aligning with the WHO Self-Help Plus protocol. Improvements in psychological well-being and quality of life are anticipated. Data from this pilot will be analyzed using both quantitative and qualitative methods, with a focus on assessing feasibility, acceptability, and perceived utility and usability in supporting women during BC treatment. Conclusions: Existing literature indicates a promising role for new technologies in delivering validated mental health interventions, highlighting the potential of digital interventions to address barriers related to social stigma and seeking assistance. This pilot is expected to provide valuable insights on the potential acceptability and usefulness of providing consistent mobile health psychoeducational support to women throughout the course of BC. International Registered Report Identifier (IRRID): PRR1-10.2196/65837