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临床试验/NCT04907604
NCT04907604Unknown不适用

European platforM to PromOte Wellbeing and HEalth in the woRkplace

Fundació Sant Joan de Déu0 个研究点目标入组 729 人开始时间: 2021年9月1日最近更新:
适应症

试验速览

阶段
不适用
入组人数
729
主要终点
Depressive symptoms

研究概览

简要总结

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.

详细描述

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.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Prevention
盲法
Single (Investigator)

入排标准

年龄范围
18 Years 至 65 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • 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)

排除标准

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

结局指标

主要结局

Depressive symptoms

时间窗: at both 7 weeks and 3-month follow-up

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

次要结局

  • Anxiety symptoms(at both 7 weeks and 3-month follow-up)
  • Perceived stress(at both 7 weeks and 3-month follow-up)
  • Well-being(at both 7 weeks and 3-month follow-up)
  • Insomnia severity(at both 7 weeks and 3-month follow-up)

研究者

申办方类型
Other
责任方
Sponsor

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