Implementation and evaluation of a multi-level mental health promotion intervention for the workplace (MENTUPP): study protocol for a cluster randomised controlled trial

Mental health difficulties and disorders in the workplace severely impact businesses through absenteeism/presenteeism, decreased productivity, workplace accidents and even self-harm and suicide [1]. Employees in some sectors may be more at risk of experiencing mental health difficulties (e.g. burnout) or disorders, such as depression and anxiety. Male-dominated workplaces, such as the construction and ICT sectors, are characterised by high levels of mental health-related stigma and low levels of help-seeking for mental health concerns, despite increased psychological distress [2]. Paradoxically, stigmatising attitudes are common in healthcare professionals, which can have a negative impact on self-care behaviours [3]. These sectors have also been associated with an increased risk of suicide among workers [4], with male construction workers in the UK being almost four times more likely to die by suicide than the general working population [5].

Certain workplace-related factors may contribute to the development, exacerbation and maintenance of mental health difficulties. For example, an association with the risk for depressive disorders has been found for the combination of high demands and low control [6], for the imbalance between high efforts and low rewards [7] and for workplace bullying [8], making the workplace an important setting for interventions. Organisation size is another factor which may contribute to employee wellbeing. Small- to medium-sized enterprises (SMEs) are the most common form of workplace in the European Union and they employ a significantly larger share of employees compared to larger organisations [9]. Research indicates that SMEs face additional workplace stressors, such as social isolation, long work hours, out-dated technologies, lack of human resource management systems, economic uncertainty and financial pressures [10, 11]. These are exacerbated by a lack of infrastructure to develop expertise, knowledge and resources to invest in workplace occupational health programmes [12‐14]. Although SMEs may not usually have the financial resources to address employee mental health, they may be in a unique position to promote mental health, prevent clinical and non-clinical mental health difficulties and reduce mental health-related stigma. The COVID-19 pandemic has further exacerbated risk factors contributing to mental health difficulties while greatly reducing social interactions and opportunities for support from colleagues. It is anticipated that the long-lasting impacts of the pandemic may include increased levels of depression, self-harm and suicidality [15‐17] as well as anxiety, post-traumatic stress disorder and sleep disorders, which may be compounded by job insecurity and long periods of isolation associated with the pandemic [18]. Europe, in particular, now is faced with a new economic crisis, caused by the war in Ukraine and the rapid increase in energy prices that are also placing great financial worries on both business and the general public.

According to a systematic meta-review, there is moderate evidence that workplace factors such as high job demands, low job control, role stress, bullying and low social support can be associated with a heightened risk for the onset of negative mental health outcomes [19]. Workplaces that intervene to offset these factors are more likely to reduce negative mental health outcomes, as well as absenteeism and presenteeism, and ultimately, may increase productivity and contribute to economic gains [11, 20‐22]. Research in the construction sector has shown that the implementation of an occupational intervention for minor depressive symptoms may prevent more serious depressive symptoms, including suicidal thoughts and behaviours [23, 24]. Furthermore, some evidence suggests educational interventions in the healthcare sector are effective in decreasing mental health-related stigma [3, 25].

The literature on workplace mental health interventions indicates that a multi-level approach which encompasses the organisational level and the individual level can be successful in reducing burnout [26‐29], anxiety [30], stress [31, 32] and stigma [33]. A key factor in the multi-level approach is the active role that management needs to play in ensuring the intervention fits with existing policies and practices within the organisation as well as providing the resources for implementation [34, 35]. Management has the ability to directly influence workplace stressors through policy, work redesign or modification of work processes and support structures [36]. Another key factor is the implementation of components that directly target the individual within the organisation, thereby implementing a top-down (via management) and a bottom-up (via employees) approach [37]. Successful workplace mental health interventions also incorporate members of the workforce in their planning and delivery, reinforcing the value of both organisational and individual level buy-in [38].

In addition to a multi-level approach, interventions that are tailored to the needs of the specific workplace or sector have the potential to be more effective [39]. This includes presenting information using images and scenarios which the individual would find relatable and providing a variety of intervention components that workplaces can choose from to fit the intervention activities to their actual needs [40]. Accessible workplace interventions are also integral to effective implementation. In recent years, interventions delivered through digital technologies have been successful in engaging a wide range of users across the organisation [41] and in reducing stress [42] and mild depressive symptoms [43].

Well-organised and managed workplaces can be a source of wellbeing [44‐46]. There has been an increase in workplaces interested in supporting their employees to prevent, detect and manage mental health difficulties and disorders in the workplace [14]. However, only 7% of mental health promotion and prevention programmes globally are workplace-based [47]. There is a need and demand for methodologically sound research studies to examine the efficacy of implementing mental health interventions designed for the workplace. At present, there is no known multi-level, tailored, flexible and accessible workplace-based mental health intervention targeting a spectrum of non-clinical and clinical symptoms. The EU Horizon 2020 project Mental Health Promotion and Intervention in Occupational Settings (MENTUPP) aims to fill this gap.

The MENTUPP workplace intervention targets clinical mental disorders (depression and anxiety disorders), non-clinical mental health problems (stress, burnout, depressive symptoms) and mental health stigma and supports positive mental wellbeing by adopting the multi-level approach. The MENTUPP intervention aims to protect mental health by promoting mental health in the workplace (primary prevention), reducing work-related risk factors (secondary prevention) and targeting mental health problems as they develop (tertiary prevention) [48] by providing guidance and support for all employees and management in the organisation. The MENTUPP approach adopts several theoretical frameworks including the Integrated Mental Health Framework by LaMontagne and colleagues [49] which includes three threads: (i) Protect mental health by controlling harmful work exposures; (ii) promote mental health by building on strengths and (iii) address mental health problems regardless of cause. Furthermore, it uses the Dual Mental Dual Continuum Wellbeing Framework by Keyes to differentiate between mental health and mental wellbeing [50]. The materials developed for the MENTUPP intervention are tailored to three at-risk sectors: construction, healthcare and information and communication technology (ICT) to enhance the uptake and potential effectiveness [51] and are available online through the MENTUPP Hub. Digital interventions are appropriate for increasing reach [52], particularly in the context of sectors that have inflexible shift patterns (i.e. healthcare, ICT), that have employees working on various sites (i.e. construction) or employees working remotely (ICT).

The overall goal of the MENTUPP intervention is to improve mental health and mental wellbeing in the workplace, with secondary aims of reducing stigma, depression and suicidal behaviour by providing tailored mental health promotion materials for the construction, healthcare and ICT sectors. MENTUPP provides SMEs with easily accessible tools for leaders and for employees that make it possible to address mental health issues on the workplace-level and the employee level.

Based on the results and experiences of a pilot study [53, 54], the present paper outlines the protocol for the cluster Randomised Controlled Trial (cRCT) which will investigate the effectiveness of the intervention in improving mental health and wellbeing (primary outcome) and reducing stigma, depression and suicidal behaviour (secondary outcome) in employees. Furthermore, multi-level workplace interventions always interact within context and can not only be assessed for their effects on mental health outcomes, but need to also have a sufficient process evaluation in order to investigate the mechanisms of effectiveness [55]. Given that resources are limited it is also insufficient just to look at the effectiveness of interventions, it is important to also consider their relative cost-effectiveness. This is particularly important in the case of SME’s which can be operating under conditions of substantial financial uncertainty. Therefore, the study will also involve a process and economic evaluation. In this article, we will present the protocol for the cRCT of the MENTUPP intervention in eight European countries and Australia.

The manuscript has been developed in line with the SPIRIT reporting guidelines [56].

For the economic evaluation, the six validated scales, the two self-developed surveys, the monitoring instrument and the log data of the MENTUPP Hub users will all be used to conduct a cost-effectiveness and cost-consequence analysis. Costs will be monitored in relation to conducting e-mental health tools and printing of leaflets and posters in all recruited SMEs. Costs in terms of productivity will be monitored via productivity/SME economic and employee turnover, absenteeism and presenteeism in the intervention and control SMEs. Absenteeism will be assessed by both self-report using customised items deduced from the iMTA Productivity Cost Questionnaire [74] and the Client Service Receipt Inventory [75]. The user data from the MENTUPP Hub will also be analysed to establish patterns of using the Hub, total number of visits and total time spent engaging with the content.

Qualtrics [76], a General Data Protection Regulation (GDPR) compliant online platform, will be used to collect data from the validated questionnaires and the two self-developed surveys. To allow matching of the data collected of the same subject at multiple timepoints, an anonymous subject-generated identification code (ID-code) will be used [77]. For participants within the control group, the Qualtrics links will be distributed by email from the local research officers. Participants will be asked to answer four neutral questions at the first of the three time points of data collection to generate an anonymous unique ID-code and ensure confidentiality. For participants in the intervention group, the Qualtrics links will be embedded in the registration process for the MENTUPP Hub. When registering for the MENTUPP Hub, participants will be asked to enter a self-chosen 4-digit code and the SME code.

The MENTUPP intervention employs a multi-level approach targeting employees and leaders within an organisation and the organisation as a whole. The materials presented through the MENTUPP Hub are designed to support SMEs in promoting mental health in the workplace for the construction, healthcare and ICT sectors, which have been associated with significant and specific workplace stressors [81‐83]. Although multi-level approaches are often recommended, high-quality studies testing multi-level approaches at the workplace are largely missing [22, 84, 85], with even fewer studies focusing specifically on SMEs and on the broad spectrum of mental health concerns from non-clinical mental health difficulties to clinical mental disorders. The MENTUPP intervention has been developed based on theoretical frameworks [48, 84], evidenced by recent literature [62‐64], an expert questionnaire [13] and was tested in a pilot study [53].

The results of this study will provide a comprehensive overview of the implementation of such an intervention in eight European countries and Australia. The MENTUPP project will not only provide an evidence-informed, tailored intervention for employees and employers of SMEs but will also provide a thorough evaluation regarding implementation processes, effects and economic impact and thereby, provide results about mental health outcomes, the associated costs and benefits, as well as a better understanding of the barriers and facilitators to using these tools in real-life settings across the healthcare, construction and ICT sectors.

This study has several strengths. Firstly, a pilot study was conducted in the same countries prior to conducting the cRCT, and thus the implementation and evaluation of the intervention has been ecologically validated. The MENTUPP intervention, as well as the implementation and evaluation strategies, has been optimised based on a systematic review and discussion among Consortium members and external stakeholders of the experience of conducting the pilot study. The visual prompts within the intervention have been enhanced and the intervention content has been refined based on feedback received during the pilot study. The implementation process has been improved by simplifying the registration procedure, which was identified as a significant barrier for participation during the pilot study. Furthermore, the evaluation strategy has been refined to reflect the core research questions and reduce the number of questions, which will improve participant experience. Moreover, a comprehensive ToC has been developed that describes in detail how we assume the intervention to work, under which conditions and what kind of changes we expect to see on the different organisational levels in the short, intermediate and long term [66].

The present study will contribute to the advancement of workplace mental health intervention programmes by designing an evidence-based and pilot-tested intervention based on implementation facilitators identified in the pilot study. This resulted in an optimised intervention and implementation strategy that adopts a flexible approach to the implementation of the intervention, which has been shown to be a facilitator to successful implementation in the literature [55, 86]. This approach involves following a standardised method whereby the local research officer in each intervention country completes a series of checklists with the Champion in the SME to determine the best approach to implementing the intervention within their organisation. The flexible but structured approach to implementing the intervention increases the ecological validity and the representativeness of the results. The study also employs a rigorous monitoring tool to control for any confounding factors that may occur in any of the organisations.

Approximately 50% of an individual’s waking hours are spent working and this can be much more for some sectors, namely the construction, healthcare and ICT sectors [87‐89]. This suggests that the workplace is a promising context for delivering mental health interventions, particularly given the literature that indicates the workplace can be associated with specific risk factors (e.g. high workload, shift work) and protective factors (e.g. peer support, supportive management) for mental health [90‐92]. This study will contribute to the literature on interventions to mitigate risk factors and enhance protective factors in the workplace as well as providing further insight into the barriers and facilitators to implementation of a workplace intervention which is currently lacking [62]. Furthermore, the intervention targets all levels of the workplace from the individual to the organisational level, which increases the likelihood of its success [93]. The MENTUPP intervention addresses not only the individual, but also encouraging active participation at the management level and the whole organisation, the MENTUPP intervention encourages workplaces to be more active in primary prevention by creating mentally healthy workplaces through reduction of known risk factors and promotion of positive aspects at work.

The intervention is available in eleven languages at present to ensure delivery to individuals in a language that most people are familiar with. This increases the likelihood that the intervention will be available to all employees of an organisation in their preferred language. Access to content in their preferred language also allows employees to relate to the intervention material and contributes to reducing stigma that can often be present in relation to help-seeking and support. This is particularly useful for employees in the construction sector who are known to be a mobile workforce. Finally, the evaluation strategy involves the use of well-standardised, internationally used measures of mental health and wellbeing and psychosocial workplace risks. The various measures will provide an accurate assessment of the outcomes experienced by participants and within organisations.

Some of the limitations associated with the study relate to the current challenging times, including the COVID-19 pandemic (particularly for the healthcare sector), increase in the cost of energy and the crisis in Ukraine (particularly for bordering European countries). These challenges may inhibit an organisation’s ability to opt into and adhere to the intervention and are outside the researchers’ control. However, the research team has attempted to alleviate these challenges by facilitating access to the intervention in a self-paced manner for workers to access in their own time, by presenting relatable material on the pandemic and tips on how to cope during the pandemic. The intervention has also been translated to the Ukrainian language to accommodate workers who may have been displaced due to the war.

The participation of SMEs and participants within SMEs is voluntary, which may cause self-selection bias to the study whereby SMEs and participants who already have an inherent interest in mental health may choose to participate. Self-selection bias into the study may limit the external validity of the study and limit the generalisability of results. However, very few research projects about mental health have been conducted in the construction industry. Therefore, even if the more interested workplaces select themselves into the study, it will be an improvement to document experiences from this sector which will help with future initiatives. Furthermore, the extensive process evaluation will nevertheless give us rich knowledge about these workplaces that will help to understand what is needed to also reach less motivated workplaces. Self-report measures employed to capture any potential change to mental health outcomes may also be influenced by response bias. As outlined above, the flexible approach to the trial may result in some variability in the reach and the implementation of the intervention in SMEs. However, this flexibility is an integral part of the study and considered a strength when applying interventions in real-life conditions.

The MENTUPP intervention is a multi-level, tailored, flexible and accessible workplace-based intervention designed to support SMEs in promoting and protecting mental health and wellbeing in the workplace, specifically for the construction, healthcare and ICT sectors, which have been associated with significant and specific workplace stressors. The results of this study will provide insight into the effectiveness, as well as the process and economic evaluation of the MENTUPP intervention in nine countries.