Despite the increasing awareness of mental health issues and concerted efforts, a significant proportion of individuals with poor mental well-being do not receive prevention actions or appropriate care [1,2]. This treatment gap is influenced by various factors, including financial constraints, limited availability of services, and societal stigma, particularly for populations susceptible to stressful situations [3,4], including pregnancy.

The pregnancy period is characterized by essential transformations in the woman, with relevant impact on her physical, mental, and social well-being. How a woman adapts to these changes can affect her quality of life (QoL) and psychological well-being. The literature highlights that various psychological symptoms can be commonly experienced during pregnancy, ranging from anxiety, stress, and depression [5-9].

To date, psychoeducational interventions that promote women’s psychological well-being during pregnancy are scarce and tend to focus primarily on subgroups of women with psychiatric symptomatology, such as perinatal depressive disorder [5,10]. Evidence of the effectiveness of psychological interventions targeting pregnant women is increasing [11], but access to support services still presents several challenges. A considerable proportion of women face geographic barriers, with specialized centers often far from their homes [12,13]. In addition, a shortage of qualified staff, such as psychologists, further limits access to specialized care [12,13]. The stigma associated with mental health problems can also prevent women from seeking psychological support in these circumstances [12,13].

The overall strategy adopted by the World Health Organization (WHO) for mental health promotion is based on principles of inclusiveness and scalability for the public and susceptible populations [14]. WHO promotes inclusive mental health by aligning with human rights, ensuring cultural sensitivity, engaging diverse stakeholders, providing accessible and tailored services, and addressing social determinants to reduce disparities [15]. Within this framework, special attention is paid to the potential role of digital technologies in promoting psychological well-being, as it can be an optimal solution [16]; women can access it from anywhere and at any time, thus remaining flexible to their needs and reducing barriers related to service availability, social stigma, and seeking help [17].

The study described in this protocol is in line with WHO strategies and aims to assess the acceptability and feasibility of an intervention delivered through digital tools to promote psychological well-being. To the best of our knowledge, the intervention, originally validated by WHO and named Self-Help Plus (SH+), has never been used on this study’s target population, pregnant women.

SH+ is a low-intensity intervention developed by a multidisciplinary and international working group [18-20]. This type of intervention is usually designed to be transdiagnostic, easily adaptable in different settings, deliverable by nonspecialists, and based on sound evidence-based psychological principles embedded in a self-help approach (guided or unguided). This approach has already been validated in various target populations such as health care workers, migrants, and refugees to promote psychological well-being and clinical interventions, demonstrating general levels of acceptability and potential effectiveness [20]. A first attempt was made to make the protocol web-based within the RESPOND (Improving the Preparedness of Health Systems to Reduce Mental Health and Psychosocial Concerns Resulting From the COVID-19 Pandemic) project, but the involvement of a human person, in the role of helper, was still necessary [21].

Cognitive behavioral therapy techniques, particularly those referring to third-generation therapy, are shown to be more suitable than other psychotherapeutic approaches to be transferred into low-intensity interventions delivered by nontraditional methods, such as eHealth applications. SH+ is based on the principles of acceptance and commitment therapy (ACT), a third-wave form of cognitive behavioral therapy [22,23], and is divided into 5 chapters that address 5 strategies for managing stress and promoting psychological well-being. The five chapters, later translated into sessions, are as follows: (1) grounding (mindfulness), (2) unhooking (defusion), (3) acting on your values (values-based behavioral activation), (4) being kind (gratitude), and (5) making room (acceptance).

In this study, “acceptability” refers to participants’ perceived appropriateness, satisfaction, and willingness to engage with the digital intervention, as captured through self-report measures of user experience (UX) and user engagement (UE), as well as through semistructured interviews. “Feasibility” is defined as the extent to which the digital delivery of the SH+ intervention can be successfully implemented in the target population, considering aspects such as ease of access, completion rates, and usability. Both constructs are aligned with widely accepted definitions in the implementation science literature [24,25].

In conclusion, this study protocol aims to make the virtual coach, ALBA (A Well-Being Assistant), platform (described in the following paragraphs) available to women by evaluating the acceptability and feasibility of delivering SH+ through an assistant created to deliver psychoeducational sessions through dialogues, video, audio, and images (ie, the 5 chapters of SH+), as well as representing a virtual coach who guides the user in carrying out assigned exercises and tasks to be done independently between sessions. Moreover, we acknowledge that not all individuals who give birth identify as women, and that the more inclusive term would be “birthing person.” However, because most cases involve women, we have chosen to use the term women in this context. When specifically referring to birthing persons, appropriate linguistic and content-related considerations will be applied. Nevertheless, future replications of this intervention may be revised to ensure greater inclusivity.

ALBA is designed to interact with pregnant women for 6 weeks, starting between weeks 14 and 26 of pregnancy. This period was chosen because the risk of miscarriage was much lower [31], a factor that could, of course, affect stress levels [32]. This will also ensure that we can complete the study before the due date of the participants. Weekly sessions are followed by the virtual coach’s instructions to independently perform some simple exercises and fill in the personal diary. The woman can choose the best day and time to interact with ALBA and perform exercises.

At the beginning of the pathway, ALBA will administer 6 self-report questionnaires, described in the Data Collection section, to establish a baseline for the examined psychological variables. After the data collection phase, the module will be administered, and its contents will be presented in different formats (ie, text, images, audio, and video).

An additional round of questionnaire administration is foreseen at the end of the intervention to assess potential changes in terms of psychological well-being and QoL perceived by the women. Four questionnaires will be administered to assess usability. To ensure the collection of all the necessary data, reminders were scheduled to complete the questionnaires 24, 48, and 72 hours after the first request. However, at present, there are no reminders for session completion.

Two months after giving birth, women from whom consent has been obtained will be invited to a semistructured interview to discuss their experience using ALBA and the app and to collect a more in-depth understanding of their experiences during the psychoeducational process. The 2-month postpartum period was chosen for both organizational convenience and methodological considerations. The expert group identified this timeframe to find a balance between scientific appropriateness and practical arrangements of the interviews, avoiding a prolonged span after the end of the intervention while ensuring that interviews with the participants were not conducted too close to the week of childbirth. The underlying assumption is that the period immediately following childbirth may be a logistically and emotionally complex time for the family, with a particular focus on the mother’s availability and experience.

Recruitment will occur within the group of pregnant women between the 14th and 26th weeks of gestation attending the pregnancy care services of the APSS in Trentino.

Midwives from the APSS hospital and territorial service were involved in the study to identify women potentially eligible to participate.

The inclusion and exclusion criteria for women to participate in the study are provided in Textbox 1.

Figure 3 shows a flowchart of the research project procedure.

This research project is designed as a proof-of-concept study, where a limited sample is sufficient to achieve the intended aims. It was calculated that if nonparametric statistics are conducted (assuming the distribution is not normal), the sample should consist of 24 pregnant women with Bonferroni correction (α=.025). The sample size and power for nonparametric tests (Kruskal-Wallis and Wilcoxon post hoc tests) were calculated according to method reported by Noether [33]. If parametric statistics are conducted (assuming the normal distribution), the sample should consist of 41 pregnant women with Bonferroni correction (α=.025). The sample calculation was further confirmed with the

Power Analysis and Sample Size (NCSS LLC) and Stata (StataCorp LLC) programs, for which the resulting numerosity is 41 participants, assuming null hypothesis (Ho):d=d0, alternative hypothesis (Ha):d≠d0, and considering as study parameters α=.025; mean of group 1 (ma1): 0.000; power: 0.800; mean of group 2 (ma2): 1.000; delta (difference of means, delta): 0.500; expected difference (da): 1.000; and SD of difference (sd_d): 2.000.

Thus, by a power level set at 0.80, a significance level of .025, and considering a 20% potential dropout rate, an estimated 50 pregnant women are needed for recruitment to conduct the study.

The ethics committee of the APSS approved this study (17241). This study was approved by the ethics committee of the APSS (17241). Recruited women who meet the inclusion criteria and consent to participate will be enrolled in the research. Participants are enrolled voluntarily and do not receive any form of compensation. Their data are pseudonymized using unique codes, and all analyses will be conducted on aggregated data, ensuring that no individual can be identified or traced.

All women who decide to participate in the study will be asked to sign an informed consent form at the time of enrollment after a careful explanation of the project; its aims; how the data will be collected, managed, and processed; the level of involvement required; and the duration of the research, as well as any confidentiality issues. The woman will also be informed of the possibility of quitting the study at any time she wishes without any explanation and that this option would not impact the quality of care or interfere with her course of treatment.

The study will be explained partially by the midwives. In addition, a video recorded by the research team explaining the study, the purpose, and the woman’s involvement in simple, understandable words will also be available. The participants will be informed of the study’s results through the app.

Regarding data protection, a privacy policy will be provided according to articles 13 and 14 of the Regulation EU 2016/679 of the General Data Protection Regulation, explaining the purposes and legal grounds of the data processing, how the personal data will be collected, their categories, how it will be managed, including the data retention period, the obligations of the data controllers, and the rights of the participants who provide data. Personal data are processed for specific research purposes within the scope of public interest tasks of the data controllers. Informed, freely given, voluntary, and explicit consent will be collected regarding the processing of particular categories of personal data (ie, data concerning health and self-reported behavioral habits in the area of lifestyle health). Moreover, specific consent will be requested regarding the possibility of contacting the participant via telephone to conduct the research interviews.

All data collected will be kept confidential and managed by authorized persons. Data necessary for evaluating the study objectives will be pseudoanonymized before processing. Copies of the study information and the privacy policy will be issued to the participant and will always be available in a dedicated section of the app.

The study manager will produce a research report and report the data responsibly and consistently. Personal data will neither be disclosed nor disseminated except in anonymized or aggregated form for publishing purposes. The publication of data from this study will take place independent of the results obtained. The transmission or dissemination of the data, through scientific journals and presentations at congresses, conferences, and seminars, will take place exclusively in anonymous form using only aggregated data that prevents any identification of the participants, even indirectly. This sharing is expected within 1 year after the conclusion of the study.

This study aims to investigate and evaluate women’s experience and engagement with the TreC Ricerca app and the virtual coach dedicated to the stress intervention (ALBA) and assess the level of pre-post psychological well-being.

First, we expect to collect relevant feedback and suggestions from the women to improve the structure of the intervention, making it more engaging and improving the interaction. Second, we intend to find differences in terms of improved pre-post psychological well-being. However, we are aware that this change may not be related to the intervention itself and that the evaluation of effectiveness will be carried out through a randomized clinical trial at a later stage.

All results will be reported and adequately discussed through a comparison with the relevant literature.

This study has several limitations that should be considered and resolved during the implementation of future studies. As mentioned earlier, it is crucial to consider that this study does not aim to evaluate the effectiveness of the intervention, which is why a control group is not planned. It will be crucial to involve a control group to assess the actual effectiveness in a randomized controlled trial. In addition, this study involves several pregnant women from the Autonomous Province of Trento, Italy. It would be interesting to extend the study to women from other regions in Italy as well.

It is important to emphasize that ALBA might be a valuable technological support in providing regular psychoeducational services for women during pregnancy. Moreover, the literature has shown that women during the perinatal period indicated a preference for online support, suggesting that the implementation of digital interventions can overcome barriers to social stigma and seeking help [71,72]. Finally, it is crucial to remember that this technological support (ALBA and TreC Ricerca app) is not a substitute for clinical and medical pathways and in-life medical support; instead, it is an additional element in promoting psychological well-being and healthy lifestyles during pregnancy.

If the results of this study are positive, we expect that, after evaluating its effectiveness, the intervention could be made available as a tool to support the psychological well-being of pregnant women.

Existing literature indicates a preference for online support among women in the perinatal period, highlighting the potential of digital interventions to address barriers related to social stigma and seeking assistance. In this context, ALBA emerges as a possible valuable resource, providing consistent psychoeducational support for women throughout the course of pregnancy.