NCT04907604

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.

Trial Health

35
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
729

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Sep 2021

Typical duration for not_applicable

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

April 28, 2021

Completed
1 month until next milestone

First Posted

Study publicly available on registry

June 1, 2021

Completed
3 months until next milestone

Study Start

First participant enrolled

September 1, 2021

Completed
1.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2022

Completed
8 months until next milestone

Study Completion

Last participant's last visit for all outcomes

August 31, 2023

Completed
Last Updated

July 7, 2021

Status Verified

July 1, 2021

Enrollment Period

1.3 years

First QC Date

April 28, 2021

Last Update Submit

July 6, 2021

Conditions

StressAnxietyDepressionInsomnia

Keywords

Mental healthWell-beingWorkplace

Outcome Measures

Primary Outcomes (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

    at both 7 weeks and 3-month follow-up

Secondary Outcomes (4)

  • Anxiety symptoms

    at both 7 weeks and 3-month follow-up

  • Perceived stress

    at both 7 weeks and 3-month follow-up

  • Insomnia severity

    at both 7 weeks and 3-month follow-up

  • Well-being

    at both 7 weeks and 3-month follow-up

Study Arms (3)

First intervention group

OTHER

Clusters 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.

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 group

OTHER

Clusters 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.

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 group

OTHER

Clusters 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

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

Interventions

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.

First intervention groupSecond intervention groupThird intervention group

Eligibility Criteria

Age18 Years - 65 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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)

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Publications (1)

  • 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.

    PMID: 40204313DERIVED

Related Links

MeSH Terms

Conditions

Anxiety DisordersDepressionSleep Initiation and Maintenance DisordersPsychological Well-Being

Condition Hierarchy (Ancestors)

Mental DisordersBehavioral SymptomsBehaviorSleep Disorders, IntrinsicDyssomniasSleep Wake DisordersNervous System DiseasesPersonal Satisfaction

Study Officials

  • Beatriz Olaya

    Parc Sanitari Sant Joan de Déu

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Ellen Vorstenbosch

CONTACT

+34 93 640 63 50e.vorstenbosch@pssjd.org

Desiree Gutierrez Marin

CONTACT

+34 93 640 63 50dg.marin@pssjd.org

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
INVESTIGATOR
Purpose
PREVENTION
Intervention Model
PARALLEL
Model Details: 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.
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

April 28, 2021

First Posted

June 1, 2021

Study Start

September 1, 2021

Primary Completion

December 31, 2022

Study Completion

August 31, 2023

Last Updated

July 7, 2021

Record last verified: 2021-07

Data Sharing

IPD Sharing
Will not share

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).