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StressEMPOWERNCT04907604

European platforM to PromOte Wellbeing and HEalth in the Workplace (EMPOWER)

A study testing A multi-modal and integrative e-health platform aimed at promoting health and reducing the negative impact of mental problems in the workplace in people with Stress and Anxiety, run by Fundació Sant Joan de Déu.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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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… Read more about this study

Who is it for?
Ages 18 to 65 yearsHealthy volunteers can take part
Conditions the study is for
Stress, Anxiety, Depression
What is being tested?
A multi-modal and integrative e-health platform aimed at promoting health and reducing the negative impact of mental problems in the workplace
Type of treatment
Medical device
Could I receive a placebo?
No, everyone receives an active treatment
How many people
729 participants
Where
No sites listed yet
Study dates
1 Sep 2021to 31 Aug 2023
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 65 years
  • All sexes
  • Healthy volunteers accepted
  • Adult, Older adult

Who may be able to join

  • 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)

Who cannot join

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

Trial locations and contacts

No sites are listed yet.

About this study

Official title: European platforM to PromOte Wellbeing and HEalth in the woRkplace

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.

Read the 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
  1. 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.

Being tested
A multi-modal and integrative e-health platform aimed at promoting health and reducing the negative impact of mental problems in the workplace
Keywords
Mental health, Well-being, Workplace
Medical subject headings
Anxiety Disorders, Depression, Sleep Initiation and Maintenance Disorders, Psychological Well-Being

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • A multi-modal and integrative e-health platform aimed at promoting health and reducing the negative impact of mental problems in the workplaceDevice

    It addresses six main domains: improving awareness of mental health problems and reducing stigma; reducing psychosocial risk factors in the workplace; improving wellbeing and reducing psychological symptoms; ensuring early detection of mental disorders; promoting healthy behaviours and lifestyles; and facilitating early return to work.

Study groups in NCT04907604
Study groupRoleWhat they receive
First intervention groupOtherClusters 1 and 2 (group 1) will start the intervention at month 1, immediately after completing the baseline assessment. After 7 weeks of using the app and having access to the EMPOWER website (with material related to the anti-stigma campaign and recommendations for employees to deal with psychosocial risk factors), they will answer a post-treatment assessment protocol through the app.
Receives: Device: A multi-modal and integrative e-health platform aimed at promoting health and reducing the negative impact of mental problems in the workplace
Second intervention groupOtherClusters 3 and 4 (group 2) that serve as control group of cluster 1 and 2 (group 1), will also complete the assessment at T1. Clusters 3 and 4 (group 2) will start the intervention in step 2, after completing the second assessment.
Receives: Device: A multi-modal and integrative e-health platform aimed at promoting health and reducing the negative impact of mental problems in the workplace
Third intervention groupOtherClusters 5 and 6 (group 3), that serve as control group of group 1 and 2, will also complete the assessment at T2. Clusters 5 and 6 (group 3) will start the intervention in step 3. All clusters will answer a total of five assessments
Receives: Device: A multi-modal and integrative e-health platform aimed at promoting health and reducing the negative impact of mental problems in the workplace

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Depressive symptoms

    Change in depressive symptomatology for employees, measured with the Patient Health Questionnaire-9 (PHQ-9) sum score. It ranges from 0 to 27, with higher scores indicating more severe symptomatology. A score higher than 19 is considered as indicative of high risk of depression

    Measured: at both 7 weeks and 3-month follow-up

Secondary outcomes (4)
  1. Anxiety symptoms

    Change in anxiety symptoms (by means of the Generalized Anxiety Disorder-7-GAD-7- total scores). The total score ranges from 0 to 21, with higher scores indicating higher level of anxiety.

    Measured: at both 7 weeks and 3-month follow-up

  2. Perceived stress

    Change of perceived stress measured with the Perceived Stress Scale-4 (PSS-4). The total score ranges from 0 to 16, with higher scores correlating with higher levels of stress.

    Measured: at both 7 weeks and 3-month follow-up

  3. Insomnia severity

    Change in insomnia severity uisng three items of Insomnia Severity Index (ISI). We will calculate a total score which will range from 0 to 16. Higher scores will indicate severe levels of insomnia.

    Measured: at both 7 weeks and 3-month follow-up

  4. Well-being

    Change in well-being (assessed with the World Health Organization-5; WHO-5 scale). The raw score ranges from 0 to 25, 0 representing worst possible and 25 representing best possible quality of life.

    Measured: at both 7 weeks and 3-month follow-up

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted1 Jun 2021
  2. Study start1 Sep 2021 (estimated)
  3. Primary completion31 Dec 2022 (estimated)
  4. Study completion31 Aug 2023 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Prevention
Allocation
Randomised
Intervention model
Parallel groups
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.
Masking
Single blind
Who is masked
Investigator
Enrolment
729 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04907604
Sponsor's protocol ID
PIC-39-20
Other IDs
Grant Agreement:848180
Acronym
EMPOWER
Status last verified
Jul 2021
First submitted
28 Apr 2021
Last updated
7 Jul 2021
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No: Despite a plan to make IPD available is not being decided yet, the aim of EMPOWER is to follow the FAIR criteria for research data. The data produced and/or used in the project should be assessable for and intelligible to third parties in contexts such as scientific scrutiny and peer review (e.g. data are provided in a way that judgments can be made about their reliability and the competence of those who created them). In that regard, EMPOWER has the intention to make (part of) the research data Findable, Accessible, Interoperable and Re-usable (FAIR).

Publications

  • Peeters SB, Thielen FW, De Mul M, Sinokki M, Olaya B, Van Der Feltz-Cornelis CM, Hakkaart-Van Roijen L. Cross-national validation of the MHQoL: psychometric evaluation and open-source tools for assessing mental health quality of life. BMJ Open. 2026 May 13;16(5):e108598. doi: 10.1136/bmjopen-2025-108598.

    PubMed 42128501
  • Salvador-Carulla L, Lukersmith S, Woods CE, Chen T, de Miquel C. A protocol using mixed methods for the impact analysis of the implementation of the EMPOWER project: an eHealth intervention to promote mental health and well-being in European workplaces. BMJ Open. 2025 Apr 9;15(4):e082219. doi: 10.1136/bmjopen-2023-082219.

    PubMed 40204313

Questions about this trial

What is this clinical trial studying?

A study testing A multi-modal and integrative e-health platform aimed at promoting health and reducing the negative impact of mental problems in the workplace in people with Stress and Anxiety, run by Fundació Sant Joan de Déu.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 5 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: status not confirmed, as of the sponsor's last update on 7 Jul 2021. Status can change between updates, so confirm with the study contact before making plans.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

Contact Ellen Vorstenbosch (+34 93 640 63 50 ext. 12544, e.vorstenbosch@pssjd.org), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Depressive symptoms (time frame: at both 7 weeks and 3-month follow-up). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04907604, which also lists 2 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 7 Jul 2021.

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