Mental health is a state of well-being in which a person can realize their potential, cope with the stresses of life, work productively, and contribute to the life of their community. It refers to a continuum that spans the promotion of well-being, the prevention of mental disorders, and the treatment and rehabilitation of people with these disorders (World Health Organization) [1]. The prevention of psychosocial risks coupled with the promotion of mental health in the workplace is a major challenge [1,2]. Hospital professionals face major mental health challenges due to the demands of their profession, characterized by a heavy workload and frequent confrontation with human distress [3-7]. The frequency of mental health difficulties among hospital professionals is significant at all stages (malaise, distress, and mental illnesses). A meta-analysis found that approximately 30% of caregivers have anxiety, 30% have depression, 30% experience psychotraumatic symptoms, and 45% have sleep disorders [8]. At the other end of the mental health spectrum, the concept of psychological flourishing is conceptualized as a positive mental health state, encompassing optimal psychological functioning in relation to various life domains [9-12]. The contribution of teamwork to mental health has been demonstrated; in this context, teamwork is defined as a collective construction enabling a shared vision of professional standards of each professional concerning their own health and safety and the management of their activity [13]. Strong team cohesion and social support networks may serve as protective factors against psychological strain [14].

The contribution to mental health and well-being of complementary health practices is gaining evidence and interest among users, professionals, and academics. The integration of conventional and complementary health practices is of particular interest [15]. Nonpharmacological interventions have evidence-based impacts [16] that are interesting for promoting mental health. The effects of mindfulness meditation (MM) in health have been extensively studied. Mindfulness is defined as a state of awareness that arises when one intentionally and nonjudgmentally pays attention to the experience of the present moment [17]. It can be trained through formal and informal mindfulness practices. Typical programs of mindfulness-based stress reduction (MBSR) or mindfulness-based cognitive therapy (MBCT) include 8 weekly in-person sessions lasting 2 to 2.5 hours, a half-day or full-day session, and a recommended 45-minute daily individual practice [18-20]. Available in a variety of protocols, it is reported to improve resilience [21] and physical and mental well-being (stress, anxiety, burnout, and affects) [22-25]. In workplace contexts, the beneficial effects of a mindfulness-based intervention (MBI) include better stress adaptation [26], fewer interpersonal conflicts, as well as improved care and patient relationships (eg, medical errors) [27-31]. More broadly, impacts are observed on relational behaviors (antisocial and prosocial) [32,33], teamwork [30,34], and performance and job satisfaction [35,36]. Managers may benefit from a strengthened aspiration to lead, with a vision more fully committed to serving others and their colleagues [37,38]. Thus, MM could be a promising practice to promote mental well-being and flourishing at work for hospital professionals [39]. However, although studies have identified benefits of an MBI at a collective level in workplace contexts, no clear explanation for such effects has been found [34,38]. Therefore, it has been recommended to explore in more detail the mechanisms by which the effects of MM at a collective level can be activated depending on the context [40].

The time constraints of typical MBIs, combined with those related to professionals’ schedules and training costs, can limit the participation of individuals, teams, and organizations in these programs [41]. Implementing such an MBI in a hospital setting is a particularly challenging endeavor, especially in the context of health care professional shortages and absenteeism. In addition, support from hospital leadership is essential for successful implementation [42]. The UK Medical Research Council (MRC) recommends that complex interventions be developed using participatory approaches [43,44]; the influence of the work environment on the implementation of MBIs in the workplace has been reported, with identification of factors that can either facilitate or hinder both implementation and effectiveness [42,45]. The benefits of mindfulness in the workplace thus depend on the intervention being implemented in a supportive context; it is therefore recommended that proposed interventions be closely aligned with the organization’s values [42]. Furthermore, ensuring participants’ sense of psychological safety during an intervention at work is essential. Psychological safety is a key mechanism potentially activated by MBIs in workplace contexts. This in turn facilitates interpersonal trust and mutual respect within the team or, conversely, feelings of relational insecurity [38,46].

MBIs in the workplace should be considered as complex interventions, given the different levels at which effects may occur (both individual and collective), as well as the variety of potential outcomes that may be observed. Methodological pluralism is a strong recommendation of the MRC for the evaluation of complex interventions, to evaluate from multiple perspectives and to better capture the mechanisms through which effects are produced [44]. Two major complementary paradigms are thus mobilized: the intervention epidemiology paradigm and the realist evaluation paradigm [43,47-49]. The latter [42] enables the assessment of the variation of effects and underlying mechanisms according to each context (hospital department) through the identification of context-mechanism-outcome configurations (CMOCs). This evaluation aims to understand how, why, for whom, and under what circumstances a given intervention is expected to produce specific results, by examining underlying mechanisms, processes, and cause-and-effect relationships. This recommended approach allows to refine the understanding of how the effects of a complex intervention—which also mobilizes social interactions—vary according to the context in which it is implemented [44]. In the area of the MBIs, there is little high-quality assessment of potential benefits and risks. Because of the difficulties of participation mentioned above, short interventions are studied, with varied content (duration and modalities), producing variable results [41]. The current knowledge on the barriers and facilitators to the implementation of MBIs in health care settings and for health care professionals justifies ensuring the implementation feasibility in such a context. The benefits obtained from its implementation in the context of real work in hospital departments are understudied [50]. No published study has examined the feasibility challenges related to the implementation of an MBI in hospital departments within the French context.

The Hospices Civils of Lyon (HCL; France) is a consortium of university-affiliated hospital facilities in France, comprising 13 different institutions and employing approximately 24,000 people [51]. In France, in accordance with the French Labor Code, employers are legally responsible for assessing occupational risks and protecting the physical and mental health of their employees. Given the presence of multiple psychosocial risk factors that may affect employees’ mental health, the HCL, together with the Occupational Health Department, initiated and developed the PROMIND study.

The aims of this pilot study are to implement a workplace-based mindfulness intervention and evaluate exploratory individual and collective outcomes among hospital professionals. The feasibility of the implementation of the intervention, the influence of the work environment, and the mechanisms through which it produces its effects are also assessed (Figure 1).

This prospective interventional pilot study, with 2 parallel groups randomized in clusters and open-label design, is being conducted at the university hospitals of Lyon (HCL), France (Figure 2). The protocol presented herein covers the step of the intervention mapping model aimed to implement (step 5) and evaluate (step 6) the intervention.

As recommended for developing complex interventions [43,44], a participatory approach was used before the study to develop and tailor the intervention to the needs and capabilities of the users, using the intervention mapping protocol (steps 1‐4) [52-54]. This stage was approved by the ethics committee of the university of Lyon (Comité d’éthique de la recherche de l’Université de Lyon; N/ref: 2022-04-14-005). Eight volunteer departments were identified during the intervention development step and matched in pairs by specialty and by geographical location among the hospitals of the HCL for control purposes (ie, medicine, geriatrics, anesthesia-intensive care, and intensive care/neonatology). A task force (34 people) included a committee of participants’ representatives (COPR) with “ambassadors” from participating departments (nurse assistants; nurses; physicians; department managers such as the department head physician, the head nurse, and the administrative manager; administrative professionals; workers’ representatives; and hospital managers), mindfulness experts, and PROMIND researchers. The COPR (24 people) attended a project presentation meeting followed by individual interviews and 4 participative workshops, including guided MM practice, delivered by an expert (a hospital physician, a university professor, and an experienced MM trainer). Qualitative data were collected, the analysis of which allowed to understand the needs and representations of professionals, including perceived barriers and facilitators at the individual, team, and organization levels. After the needs assessment and a literature review, the modalities of the intervention (frequency, location, and content) were decided in close collaboration within the task force. The executive management of the HCL was mobilized as a key stakeholder from the start of the development of the intervention, to support the participation of department managers and teams, including communication, funding, and material assistance: premises were made available, and the study was considered as work and training time, as were trips made specifically for the study. The objective of the co-construction step was to adapt the intervention to the context, improve the adherence to the project, and improve the understanding of MM practice.

The study was proposed to all professionals in the 8 departments, on a voluntary basis. The call for participation and the collection of consent were carried out after the study information meeting. Participants were not aware of their department’s allocation group at the time of enrollment.

The inclusion criteria for the study were being employed by the hospital and working in one of the participating departments, being aged ≥18 years, and being willing to give written informed consent. The exclusion criteria were having a self-reported neuropsychiatric disorder with current severe clinical instability (severe depressive or affective disorder, severe anxiety disorder, psychotraumatic disorder, severe dissociative disorder, psychotic disorder, epilepsy, etc), being unable to understand or write in French, and being pregnant or breastfeeding.

Premature study exit criteria were acute neuropsychiatric symptoms uncontrolled during the study (eg, severe dissociation, major anxiety, and severe behavioral disturbance) and withdrawal of consent to participate. Participants who left the study were not replaced. Simultaneous participation in another study was not prohibited unless it involved the use of a psychotropic or psychotropic-like drug or proposed psychiatric or psychological follow-up.

The MM information meeting was opened to the professionals in the 8 participating departments. The definition of MM and various representations of this concept were discussed. Media were used, including testimonies from experts, COPR professionals, and peers and a participatory game.

Randomization was carried out by the biostatistics team after the MM information meeting. Randomization was carried out at the department level and stratified by department type (medicine, geriatrics, anesthesia-intensive care, and intensive care/neonatology) to ensure that each department type was represented in both the intervention group (4 departments) and control group (4 departments). Cluster randomization was chosen to prevent contamination within departments, as professionals work closely together.

The MM trainer was external to both the hospital and the initial step of the study. The most appropriate time slots were proposed by the department.

The MM program was derived from the Caring Mindfulness-Based Approach for Seniors (CMBAS) program [55]. The CMBAS follows the general format of an MBSR program, consisting of an initial one-on-one interview; 8 weekly, 2-hour, group-based sessions; and a half day of meditation practice in the sixth week of the program. It is specifically tailored to the needs of older adults, building on modifications suggested by Zellner Keller et al [56] together with a focus on compassion and loving-kindness meditation. Older adults and hospital professionals share a common experience characterized by human and existential vulnerability—encompassing their relationship to finitude and death, physical decline and illness, and the pursuit of meaning amid these experiences [57]. For the PROMIND pilot study, we customized its psychoeducational and practice components, its duration, and number of sessions to be adapted to the population of hospital professionals. Practical exercises were proposed to help them with their emotions, thoughts, and feelings. Participants were asked to engage in home practice, which consisted of formal guided meditations and informal practices aimed at helping to generalize mindfulness skills to daily life. Audio recordings of guided meditation based on the in-person sessions were made available on the hospital’s e-learning support platform (with monitoring of each participant’s connections); additional audio recordings may be proposed according to the needs perceived by participants as the program progresses, selected to match the proposed sessions.

Qualitative and quantitative data will be analyzed separately. Integration will be performed subsequently to identify points of convergence and divergence and to generate hypotheses for further analysis. We will apply a table of convergences and divergences between the results, the interpretation of which will be discussed by the interdisciplinary team and compared to the literature. Feasibility as an outcome will be evaluated according to an overall informed decision-making framework [44], based on prespecified indicators and conclusions based on a realist approach: exploratory outcomes of the intervention, feasibility, and barriers and facilitators identified for each context; consistency with the theoretical logic model; and potential for organizational adaptation. They will be analyzed in each department context to inform trends and assess the barriers and facilitators to inform future scalability. This integrated analysis, rather than isolating the components, will provide a more comprehensive assessment of effectiveness, feasibility, and implementation.

This study was approved by the Sud-Est VI ethics committee (Clermont Ferrand, France) and the French national data protection authority (Commission nationale de l’informatique et des libertés, CNIL). The study was registered on ClinicalTrials.gov (NCT06331065). Written informed consent was obtained from participants, as required by French law for this type of study. All participants were informed of the study objectives and data confidentiality. Information was provided to the HCL Social and Economic Committee training group.

This protocol has been described in compliance with the SPIRIT (Standard Protocol Items: Recommendations for Interventional Trials) 2025 checklist (Checklist 1) [77].

This study expects that the co-constructed workplace-based mindfulness intervention is an acceptable and relevant intervention for French hospital professionals: we hypothesize that the implementation of this MBI improves psychological flourishing in the workplace in 4 hospital departments in comparison with a geographical control and, more broadly, mental health at work at the individual and collective levels. With the intervention modalities chosen in accordance with the intervention mapping protocol [53], we expect that this improves the relevance of the study and the feasibility of its implementation.

The originality of the PROMIND study is the adoption of a structured approach to intervention planning in mental health promotion for hospital professionals. The strengths of this innovative study lie in the improvement strategies employed, including the co-construction, and the collective approach to the intervention and to the MM program within a team that usually works together (department) [78]. Moreover, this MBI is a multiprofessional training course that also transmits practical resources and is prepared as an organizational intervention, taking into consideration the views of professionals, which is conducive to team effectiveness [79]. The participatory development with stakeholders is one of the recommendations for promoting the feasibility of implementation, the relevance, and ultimately the sustainability of the proposed intervention [44,53]. The initial co-construction step enabled the emergence of local “ambassadors” within the participating departments involved in relaying study information and their motivation; the identification of main MBI components, such as professional time that could be allocated to training (eg, interval and duration of sessions); and the communication strategies to support participation. This also facilitated the support and practical involvement of hospital executive management throughout the study, and it is known that culture and infrastructure also improve feasibility [45]. In addition, a reduced duration of practice sessions was chosen for this MBI adapted for hospital professionals. While brief interventions can facilitate access to a meditation training program, the dose proposed must be sufficient to ensure effectiveness [41] and requires specific evaluation.

The innovative feature of this study is the adoption of a mixed evaluation methodology. The methodological pluralism is based on a randomized controlled pilot study with a complementary approach of realist evaluation, due to the complex nature of the intervention [44]. Intervention epidemiology raises the challenge of choosing a primary outcome, whereas mental health is a complex domain, which requires the use of several questionnaires for a reliable assessment. The EEPMT-13 is an innovative tool to specifically explore mental health in the workplace, which requires further exploration. The focus of the evaluation on positive mental health opens up a viewpoint that complements the approaches to distress at work, to adopt a broader view of mental health as a continuum [80,81]. Most studies investigating MM among hospital professionals investigate burnout using questionnaires such as the Maslach Burnout Inventory Scale as a specific tool for assessing distress in the workplace [41]. However, some consider that it is not based on a solid theoretical model and that the construction of certain items is questionable [82]. Otherwise, they use non–workplace-specific and routine mental health assessment criteria (eg, anxiety, stress, and quality of life) [41]. The complementary realist evaluation approach provides a deeper and sharp understanding of this complex domain at the individual and organization levels and in the patient care relationship [59]. Although this pilot study may not provide conclusive evidence, it will provide useful knowledge on how these interventions work in a real-world hospital setting and on the extent to which MM can promote mental health in an organizational environment with psychosocial risk factors. Finally, this mixed methods design is especially appropriate for pilot studies of complex interventions where the exploratory primary outcome of effectiveness as well as feasibility and processes must be explored.

In this pilot study, inclusion was limited to hospital care departments. However, hospitals include technical and administrative departments with specific needs that may require adaptation of the intervention. This will require a new dedicated study. In addition, while all willing professionals from participating departments can be included, only part of the team can participate in the MM program because the number of people is limited per group (n=15). Moderately sized groups are therefore usual in MBI, and group size varies according to the program and practice contexts [55,71,72]. This limits the potential impact of MBI on the departments and work organization, which will be assessed through realist evaluation. In a larger-scale study, it may be interesting to train more professionals at the same time in each department, based on the evaluations of this pilot study. It would also be important to include more departments in a larger-scale study. Indeed, in this pilot study, only 2 groups comprising 4 departments each could be included. Any associations identified in this study should therefore be interpreted with caution due to the risk of bias and will need to be confirmed during the scalability stage. Furthermore, the demands associated with the mixed methods evaluation in the study, particularly in terms of the time required, complicate the implementation of an intervention among a specific population for whom the issue of availability and task prioritization is a major concern. The self-administered questionnaires may induce a desirability bias [83]. However, the quantitative assessment is fast. In addition, the self-administered questionnaires can reduce anxiety during the assessment and investigate behaviors that are difficult to observe in other ways [84]. This pilot study has an open-label design, which may introduce bias. The delivery of the MM sessions by an external trainer limits the impact of the lack of blinding during the MM program.

The results of this pilot study will provide essential data and input for the sustainable and larger-scale implementation of MBIs in the workplace, facilitating access to relevant, evidence-based interventions to support the mental health of hospital professionals. The challenges of implementation and evaluation of a workplace-based mindfulness intervention adapted to hospital professionals are multiple and complex; the use of a health program planning model such as the intervention mapping protocol is important for structuring the steps of co-construction, implementation, and evaluation of the intervention. Participative research and cooperation between hospital professionals, researchers, experts in MM, and the hospital management are essential to promote the success of initiatives such as this.