A Mindfulness-Based App Intervention for Pregnant Women: Study Design, Development, and Preliminary Testing of a Prototype.

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 a virtual assistant with wide reach and dissemination. This paper describes 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 (MBCP) programme and adjusted to electronic format through multiple iterations with stakeholders.

Results: An 8-session-based intervention in prototype electronic format through text, audio, video, and images was designed. In general, the prototypes were evaluated positively by the users involved. The questionnaires show 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 substitute 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 propose 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.