METRIKAMIND - Development of a Digital Mental Health Ecosystem for Workplace Environments
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 400
- 试验地点
- 1
- 主要终点
- Battery of Psychological Assessment (PHQ9)
研究概览
简要总结
The goal of this observational study is to develop and validate a digital ecosystem designed to assess and manage mental health in workplace environments. The primary purpose is to understand how digital tools can contribute to better mental health management and to gauge their effectiveness in a typical work setting. The study also aims to enhance the prediction of mental health outcomes and the course of mental health conditions through more accurate assessments. The main questions it aims to answer are:
- How do digital assessments improve the detection and management of mental health issues like depression and anxiety in the workplace?
- Can a digital ecosystem effectively reduce the overall cost and impact of mental health issues on productivity and employee well-being?
- How effective are bifactor models in detecting and mitigating the impact of faking in self-reported mental health assessments in occupational settings?
Participants will:
- Engage with the Metrikamind platform to complete periodic mental health assessments.
- Provide feedback on their experience and any changes in their mental health status, with particular attention to the accuracy and honesty of self-reported data facilitated by the implementation of bifactor models.
- Participate in follow-up surveys to gauge long-term effects of using the digital tools on their mental health and workplace productivity.
This study involves adult participants currently employed in various sectors undergoing a sick leave, who will use the Metrikamind platform over a six-month period. The research aims to collect data on the usability and effectiveness of the platform, analyzing changes in participants' mental health through their interaction with the digital tools provided. By incorporating advanced psychometric techniques like bifactor models, the study seeks to enhance the reliability of data and improve the prediction of mental health outcomes, providing a solid foundation for potential wider application in corporate health strategies.
详细描述
Background and Rationale:
Mental health in the workplace is a growing concern globally, with significant impacts on productivity, employee engagement, and overall organizational health. Traditional methods of addressing mental health at work often fall short due to lack of early detection, stigma associated with mental health issues, and inadequate monitoring of interventions, but also faking good or bad due to absenteeism or presentism. The Metrikamind project aims to address these challenges by developing a robust digital ecosystem that facilitates early detection, continuous monitoring, and effective management of mental health issues within the workplace, while mitigating faking. This system leverages the latest advancements in psychometrics and digital health technologies to create a user-friendly, scalable, and scientifically valid tool that can be integrated into everyday work environments.
Objective:
The primary objective of the Metrikamind project is to validate the effectiveness of a digital mental health assessment and management system in improving the detection, monitoring, and management of mental health issues in workplace settings. The project will evaluate how such digital tools can contribute to reducing the economic and human costs associated with workplace mental health issues, such as depression and anxiety.
Study Design:
研究设计
- 研究类型
- Observational
- 观察模型
- Ecologic Or Community
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Adults aged 18 to 70 years.
- •Currently on sick leave due to mental health issues.
- •Has access to and is capable of using a digital device (smartphone, tablet, or computer) to interact with the Metrikamind platform.
- •Proficient in the language of the intervention and assessment tools.
排除标准
- •Individuals with severe psychiatric conditions requiring inpatient care or those at high risk of suicide, which might complicate the intervention or pose a danger to the participant.
- •Significant cognitive impairments that would interfere with the participant's ability to comprehend or engage with the digital platform or to provide reliable self-reported data.
- •Currently participating in other clinical trials that might interfere with the outcomes of this study.
- •Lack of regular access to internet services, which are necessary for the digital intervention and data collection.
结局指标
主要结局
Battery of Psychological Assessment (PHQ9)
时间窗: Six Months
The primary outcome measure in this clinical trial uses several validated scales to evaluate depression and anxiety: Patient Health Questionnaire-9 (PHQ-9, range: 0-27, 4-point Likert scale: 0 = 'Not at all' to 3 = 'Nearly every day'), with higher scores indicating worse outcomes. Scores from these scales will be standardized to allow aggregation into a composite index reflecting overall psychological distress. This unified metric simplifies the presentation of results, enhancing the clarity of the intervention's impact on mental health outcomes while maintaining statistical integrity.
Battery of Psychological Assessment (HADSA)
时间窗: Six Months
The primary outcome measure in this clinical trial uses a validated scale to evaluate depression and anxiety: Hospital Anxiety and Depression Scale (HADS, range: 0-21 for both anxiety and depression subscales, 4-point Likert scale: 0 = 'Not at all' to 3 = 'Most of the time'), with higher scores indicating worse outcomes. Scores from these subscales will be standardized to allow aggregation into a composite index reflecting overall psychological distress. This unified metric simplifies the presentation of results, enhancing the clarity of the intervention's impact on mental health outcomes while maintaining statistical integrity.
Battery of Psychological Assessment (PROMIS)
时间窗: Six Months
The primary outcome measure in this clinical trial uses a validated scale to evaluate depression and anxiety: Patient-Reported Outcomes Measurement Information System (PROMIS, range: 8-40 for each domain, 5-point Likert scale: 1 = 'Never' to 5 = 'Always'), with higher scores indicating worse outcomes. Scores from these scales will be standardized to allow aggregation into a composite index reflecting overall psychological distress. This unified metric simplifies the presentation of results, enhancing the clarity of the intervention's impact on mental health outcomes while maintaining statistical integrity.
Battery of Psychological Assessment (CESD-R)
时间窗: Six Months
The primary outcome measure in this clinical trial uses a validated scale to evaluate depression: Center for Epidemiologic Studies Depression Scale - Revised (CESD-R, range: 0-60, 5-point Likert scale: 0 = 'Not at all' to 4 = 'Nearly every day'), with higher scores indicating worse outcomes. To ensure coherence and robust analysis, scores from this scale will be standardized, allowing for aggregation into a composite index reflecting overall psychological distress. This index will provide a unified metric for evaluating the effectiveness of the intervention across diverse mental health dimensions. The standardization and aggregation process will maintain statistical integrity while simplifying the presentation of results, facilitating a clearer understanding of the intervention's impact on mental health outcomes.
Battery of Psychological Assessment (SAS)
时间窗: Six Months
The primary outcome measure in this clinical trial uses a validated scale to evaluate anxiety: Zung Self-Rating Anxiety Scale (SAS, range: 20-80, 4-point Likert scale: 1 = 'A little of the time' to 4 = 'Most of the time'), with higher scores indicating worse outcomes. To ensure coherence and robust analysis, scores from this scale will be standardized, allowing for aggregation into a composite index reflecting overall psychological distress. This index will provide a unified metric for evaluating the effectiveness of the intervention across diverse mental health dimensions. The standardization and aggregation process will maintain statistical integrity while simplifying the presentation of results, facilitating a clearer understanding of the intervention's impact on mental health outcomes.
Battery of Psychological Assessment (GAD7)
时间窗: Six Months
The primary outcome measure in this clinical trial uses several validated scales to evaluate depression and anxiety: Generalized Anxiety Disorder-7 (GAD-7, range: 0-21, 4-point Likert scale: 0 = 'Not at all' to 3 = 'Nearly every day'), with higher scores indicating worse outcomes. Scores from these scales will be standardized to allow aggregation into a composite index reflecting overall psychological distress. This unified metric simplifies the presentation of results, enhancing the clarity of the intervention's impact on mental health outcomes while maintaining statistical integrity.
次要结局
未报告次要终点
研究者
David Gallardo-Pujol
Professor of Psychology
University of Barcelona