Clinical Trial Details
— Status: Not yet recruiting
Administrative data
| NCT number |
NCT04907604 |
| Other study ID # |
PIC-39-20 |
| Secondary ID |
Grant Agreement: |
| Status |
Not yet recruiting |
| Phase |
N/A
|
| First received |
|
| Last updated |
|
| Start date |
September 1, 2021 |
| Est. completion date |
August 31, 2023 |
Study information
| Verified date |
July 2021 |
| Source |
Fundació Sant Joan de Déu |
| Contact |
Ellen Vorstenbosch |
| Phone |
+34 93 640 63 50 |
| Email |
e.vorstenbosch[@]pssjd.org |
| Is FDA regulated |
No |
| Health authority |
|
| Study type |
Interventional
|
Clinical Trial 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.
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.
