• A Chatbot-Based Version of a World Health Organization–Validated Intervention (Self-Help Plus) for Stress Management in Pregnant Women: Protocol for a Usability Study

    stage 1

    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 such as coaches on smartphones are emerging as valuable tools to support the psychological well-being of pregnant women without existing disorders. Objective: This study aims 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 acceptance and commitment therapy–based stress management mobile app. The primary objective is to explore the feasibility of using a coach, ALBA (A Well-Being Assistant), developed within the TreC Ricerca app, to promote women’s psychological well-being during pregnancy through 5 sessions based on acceptance and commitment therapy. The pre- and postintervention effects on psychological well-being will also be explored as a secondary objective, serving as a proxy for the 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 fulfill 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, using a convenience sampling approach. ALBA will interact with the participating women for 6 weeks, between the 14th and 26th weeks of gestation. Specifically, there will be 1 session per week, which the woman can choose, to allow more flexibility regarding 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 Rating Scale. Moreover, other quantitative outcome measures include levels of stress, anxiety, depression, emotional regulation, psychological flexibility, coping strategies, self-efficacy, and overall well-being, along with qualitative data from semistructured interviews. Finally, the analysis of the data gathered in this study will primarily adopt descriptive statistics and a 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 pregnancy.

    Silvia Rizzi, Valentina Fietta, Lorenzo Gios, Stefania Poggianella, Maria Chiara Pavesi, Chiara De Luca, Debora Marroni, Claudia Paoli, Anna Gianatti, Barbara Burlon, Vanda Chiodega, Barbara Endrizzi, Angela Giordano, Francesca Biagioli, Veronica Albertini, Marianna Purgato, Corrado Barbui, Chiara Guella, Erik Gadotti, Stefano Forti, Fabrizio Taddei·2025·JMIR Research Protocols
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  • A Human-Centered Approach for a Student Mental Health and Well-Being Mobile App: Protocol for Development, Implementation, and Evaluation

    stage 1

    Background: The rising prevalence of mental health concerns among students is prompting universities to explore innovative solutions to support student well-being. This paper describes the protocol for the development, implementation, and evaluation of a mobile app designed to address the mental health and wellness needs of students. This project employs a student-centered approach, partnering with students from the initial needs analysis through to the final design and implementation stages. Objective: The app aims to increase the use of campus resources that address student mental health and wellness by improving the awareness of these resources through user-designated preferences that are established on the initial use of the app and then iteratively refined as it is used. The app is linked to the campus student’s electronic health record so that health and wellness services can be coordinated and enhanced and the student journey to and through care become more seamless. The long-term objective is to leverage data from both the app and electronic health record to improve individual and population health for the entire campus. Methods: At the beginning of the project, a comprehensive logic model was created to outline the core inputs, activities, outputs, outcomes, and long-term impacts that were desired for the app. The model emphasized the integration of the app within existing campus mental health and wellness services and its potential to foster a culture of well-being across the university community. An evaluation plan was developed that incorporates both quantitative and qualitative methods through biannual assessments to track trends and app impact across campus in addition to feasibility, acceptability, and usability as well as its reach, effectiveness, and sustainability. Validated measures such as the Patient Health Questionnaire and Generalized Anxiety Disorder scale were selected to track changes in mental health and wellness, while custom surveys and analytics will gauge user engagement and satisfaction. New students, including freshmen, transfers, and first-year medical students, are invited to participate after giving informed consent. They receive compensation for their involvement in both quantitative and qualitative assessments. Results: As of March 2025, we have collected over 600 survey responses from freshmen, transfer, and medical students. A second survey round and additional focus groups are planned for April to May 2025. No analyses have been conducted yet. The findings from this project have the potential to inform similar efforts at other institutions and contribute to the broader field of digital mental health innovation and the development of well-being interventions tailored for young people. Conclusions: By leveraging digital technology and actively engaging students in supporting their well-being, this initiative represents an innovative user-centered approach to improve mental health and wellness support on university campuses.

    Maryam Gholami, David Wing, Manas Satish Bedmutha, Job Godino, Anahi Ibarra, Byron Fergerson, Nicole May, Christopher A. Longhurst, Nadir Weibel, Anne Duffy, Heidi Rataj, Karandeep Singh, Kevin Patrick·2025·JMIR Research Protocols
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