Clinical trial NCT04907604: European platforM to PromOte Wellbeing and HEalth in the Workplace (EMPOWER)
Official title: European platforM to PromOte Wellbeing and HEalth in the woRkplace
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Stress
Anxiety
Depression
Insomnia
Keywords: Mental health
Well-being
Workplace
Lead sponsor: Fundació Sant Joan de Déu
Sponsor class: OTHER
Collaborators: name: Universidad Autonoma de Madrid
name: Erasmus University Rotterdam
name: Fondazione I.R.C.C.S. Istituto Neurologico Carlo Besta
name: University of York
name: Fondazione Adapt
name: Schweizer Paraplegiker Forschung
name: Australian National University
name: City of Turku
name: Ómada Interactiva SLL
name: Instytut Medycyny Pracy Imienia Prof. Dra Med. Jerzego Nofera W Lodzi
name: University of Lodz
name: Vrije Universiteit Brussel
First posted: 2021-06-01
Enrollment: 729
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: It will conduct a stepped wedge cluster randomized trial with randomization on the company level, each company representing one cluster. The design involves random and sequential crossover of clusters from control to intervention until all clusters are exposed. Data collection continues throughout the study so that each cluster contributes observations under both control and intervention observation periods. This design was selected in order to retain the power of randomization while offering all companies enrolled in the trial the desirable intervention.
Primary purpose: PREVENTION

Brief summary: EMPOWER is a multidisciplinary research and innovation effort aiming to developing, implementing, evaluating and disseminating the effectiveness and cost-effectiveness of a modular eHealth intervention platform to promote health and well-being, reduce psychological distress, prevent common mental health problems and reduce their impact in the workplace. In collaboration with stakeholders, we will adapt existing effective interventions focused on different components (awareness and stigma, workplace conditions and psychosocial factors, stress, common mental health symptoms, early detection, comorbidity, lifestyle, and return to work) to created a combined online modular platform feasible in various workplace settings by culturally and contextually adapting it. The intervention will be implemented through a stepped wedge cluster randomized trial directed to employees and employers of small and medium sized enterprises and public agencies from three European countries (Spain, Finland and Poland) and United Kingdom. Both qualitative and quantitative methods will be used in the evaluation of the individual health outcomes, cost-effectiveness (from a social, economical, employer and employees perspective), and implementation facilitators and barriers. Implementation strategies relevant to the uptake of the EMPOWER intervention will be identified, including a realistic appraisal of barriers to uptake as well as evidence-based solutions to these barriers. Through scaling-up pre-existing effective and cost-effective interventions, EMPOWER is aimed at addressing the overarching challenges from different perspectives, including individual level (e.g., addressing stigma, mental health, well-being and lifestyles, taking into account legal, cultural and gender issues) and organizational level. The main outcomes effort will help employees, employers and policymakers in decision processes of new legal and contractual framework at EU and national level covering the new economy landscape.

Detailed description: The EMPOWER Project's main objective is to develop, test and evaluate a multi-modal and inclusive e-Health platform, compiling the most feasible, brief and cost-effective interventions currently available in Europe to promote health and wellbeing, prevent mental health problems and reduce the impact of mental health problems in the workplace.

Specifically, three intervention levels will be represented by interventions within the eHealth platform that are specially designed for the relevant populations and desired outcomes:

1. Universal (primary) prevention: interventions to improve awareness and reduce stigma; to reduce psychosocial risk factors and providing early detection of mental disorders.
2. Secondary prevention programs: interventions designed to improve wellbeing and reduce psychological distress and to promote healthy lifestyles. EMPOWER individual eHealth intervention will be based on the following components:

   * Psychoeducational material.
   * Challenges
   * Tracking
3. Tertiary prevention program: return to work intervention. The intensive collaborative approach will design strategies to overcome the barriers that have already been identified for the widespread implementation of programs to promote wellbeing and reduce mental health problems in the workplace. EMPOWER aims to address the increasing burden of mental health problems in the workplace and improve mental health in the EU working population, having a positive impact on productivity. Partners from the consortium are coming from countries such as Spain, Italy, Netherlands, Poland, UK, Switzerland and Australia.

An eHealth platform to reduce the impact of mental health problems at the workplace Mental health problems cause an enormous burden both for the individual and the society. A number of interventions have been developed to promote wellbeing and prevent or treat mental disorders in the workplace. Attempts to implement interventions by means of digital technologies have had statistically significant but minimally positive effects in reducing overall mental health problems, such as depression, anxiety and stress. However, most eHealth interventions focus on a single mental health condition and neglect comorbidity, particularly in the case of the more common mental disorders. Although effective and cost-effective workplace interventions are available, widespread implementation face a number of barriers. The stigma and discrimination at the workplace have been associated with delayed access to treatment, weakened social support, difficulties in the performance of occupational and social roles, unemployment, and diminished self-esteem. Although anti-stigma interventions targeting the general population and workplace settings have been implemented, there is room for improvement.

Collaboration among stakeholders is essential when developing and implementing effective interventions to reduce the impact of mental health problems at the workplace and evaluate their impact. The organization of work is rapidly changing. This growing diversity of what it means to work makes it clear that addressing mental health issues at the workplace will require ingenuity and flexibility to tailor interventions to the realities of the workplace setting.

The Framework Directive on Occupational Safety and Health, 89/391/EEC, lays down the employers' general duty to ensure workers' health and safety, "addressing all types of risk". Although the Framework does not explicitly address mental health issues in the workplace, it implicitly addresses them since it requires the employer to be aware of and address all types of health-related risks. At the same time, the European Commission's 2008 European Pact for Mental Health and Well-being20 and the 2016 European Framework for Action on Mental Health and Well-being21 have clearly raised the issue of mental health as a public health priority across society and the economy, mentioning workplace mental health as one target area. Although there has not as yet been a direct regulatory focus on mental health in the workplace, there is certainly a general consensus that it is incumbent on European employers to adequately identify and address known psychosocial risks.

Due to the fragmented landscape of interventions and related implementation barriers, there is an urgent need for a multi-modal and integrative eHealth platform aimed at reducing mental health problems in the workplace and improving employees' wellbeing, by compiling the most feasible, brief and cost-effective interventions currently available in Europe. The platform will take advantage of proven cost-effective tools and address the need to reduce stigma, increase help-seeking behaviour, raise awareness about and minimalize psychosocial risks, improve self-management strategies, taking into account mental and physical comorbidities, and promote a healthy lifestyle - all while considering gender and cultural differences that impact successful implementation. This is especially relevant for small and medium enterprises (SMEs), which represent the majority of all enterprises in the EU but have very limited resources. The development and implementation of a multi-modal and integrative eHealth platform should, finally, be guided and supported by close collaboration with stakeholders, including employee and employer organisations, insurance companies, patient associations, and health professionals.

Eligibility criteria: Inclusion Criteria:

* Older than 18 years
* Having a mobile phone with internet access
* Having sufficient knowledge of the local language
* Accepting the informed consent.
* Being employed at the time of recruitment (baseline)

Exclusion Criteria:

* Younger than 18
* Not having sufficient knowledge of the local language
* Being unemployed at the time of recruitment (baseline)

Primary outcomes:
measure: Depressive symptoms
timeFrame: at both 7 weeks and 3-month follow-up
Secondary outcomes:
measure: Anxiety symptoms
timeFrame: at both 7 weeks and 3-month follow-up
measure: Perceived stress
timeFrame: at both 7 weeks and 3-month follow-up
measure: Insomnia severity
timeFrame: at both 7 weeks and 3-month follow-up
measure: Well-being
timeFrame: at both 7 weeks and 3-month follow-up
Other outcomes:
Locations:
Study officials:
affiliation: Parc Sanitari Sant Joan de Déu
name: Beatriz Olaya
role: PRINCIPAL_INVESTIGATOR
References: