METRIKAMIND - Development of a Digital Mental Health Ecosystem for Workplace Environments

NCT06650176 | Not Yet Recruiting

• 1 other identifier: CPP2021-008590
• Study Type: observational
• Target: 400
• Locations: 1 country
• Sites: 1

Brief Summary

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:

1. 1.How do digital assessments improve the detection and management of mental health issues like depression and anxiety in the workplace?
2. 2.Can a digital ecosystem effectively reduce the overall cost and impact of mental health issues on productivity and employee well-being?
3. 3.How effective are bifactor models in detecting and mitigating the impact of faking in self-reported mental health assessments in occupational settings?
4. 4.Engage with the Metrikamind platform to complete periodic mental health assessments.
5. 5.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.
6. 6.Participate in follow-up surveys to gauge long-term effects of using the digital tools on their mental health and workplace productivity.

Conditions

Depression Disorders; Anxiety

Keywords

depression; anxiety; workplace; faking good; faking bad; psychometrics; absenteeism; presentism

Outcome Measures

Primary Outcomes (6)

• Battery of Psychological Assessment (PHQ9)

  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.

  Six Months

• Battery of Psychological Assessment (HADSA)

  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.

  Six Months

• Battery of Psychological Assessment (PROMIS)

  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.

  Six Months

• Battery of Psychological Assessment (CESD-R)

  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.

  Six Months

• Battery of Psychological Assessment (SAS)

  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.

  Six Months

• Battery of Psychological Assessment (GAD7)

  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.

  Six Months

Study Arms (1)

Workers on sick leave

This cohort consists of workers currently on sick leave due to mental health issues, specifically anxiety and depression, being managed by a "Mutua Colaboradora de la Seguridad Social" in Spain. The intervention targets this population to assess and improve mental health through the Metrikamind digital platform, aiming to facilitate their recovery and return to work. Participants are adult employees from various sectors, ensuring a diverse and representative sample. The study focuses on employing the Metrikamind platform's advanced psychometric tools, including bifactor models, to accurately assess and manage the participants' mental health. This intervention seeks to validate the effectiveness of digital health tools in reducing the duration of sick leave and improving overall mental well-being, thereby supporting employees in their transition back to regular work activities.

Behavioral: Lifestyle Management

Interventions

Lifestyle Management BEHAVIORAL

The Metrikamind intervention features a unique digital ecosystem designed to manage mental health specifically in workplace contexts, with a focus on aiding recovery and facilitating the return to work for employees on sick leave. This innovative tool employs bifactor models to enhance the accuracy of self-reported data, effectively countering potential faking behaviors. Through continuous, real-time data collection on a user-friendly platform, Metrikamind tracks and assesses various mental health conditions, including stress, anxiety, and depression. The intervention\'s advanced analytics enable personalized feedback and targeted interventions, improving the detection, management, and ultimately, the mitigation of mental health issues. By focusing on individuals currently unable to work due to mental health challenges, Metrikamind aims to support their recovery and accelerate their readiness to return to work, thus addressing both immediate and long-term recovery trajectories.

Workers on sick leave

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

The study population for this clinical trial will be sourced from employees currently on sick leave due to mental health issues, who are being followed up by a Mutua Colaboradora de la Seguridad Social in Spain. These employees typically represent a range of industries and occupations, highlighting a diverse workforce experiencing mental health challenges that impact their ability to work. This population is characterized by individuals who are in the process of receiving or awaiting benefits from the social security system due to their health-related work absences. Participants will be selected based on specific inclusion and exclusion criteria to ensure that they are suitable for a study assessing the effectiveness of digital interventions aimed at improving mental health and facilitating a return to work. The selection will focus on adults aged 18 to 65 who have a diagnosed mental health condition such as anxiety or depression, ensuring a relevant and representative sample.

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• David Gallardo-Pujol: lead

Study Sites (1)

Faculty of Psychology

Barcelona, Barcelona, 08035, Spain

Location

MeSH Terms

Conditions

Anxiety Disorders; Depression

Condition Hierarchy (Ancestors)

Mental Disorders; Behavioral Symptoms; Behavior

Central Study Contacts

David Gallardo-Pujol, PhD in Clinical Psychology

CONTACT

34 93 312 58 65; david.gallardo@ub.edu

Study Design

• Study Type: observational
• Observational Model: ECOLOGIC OR COMMUNITY
• Time Perspective: PROSPECTIVE
• Target Duration: 6 Months
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Professor of Psychology

Study Record Dates

• First Submitted: October 1, 2024
• First Posted: October 21, 2024
• Study Start: September 30, 2025
• Primary Completion: April 30, 2026
• Study Completion: April 30, 2026
• Last Updated: March 27, 2025

Record last verified: 2025-03

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF, CSR, ANALYTIC CODE
• Time Frame: In accordance with current standards in psychology, the anonymized individual participant data (IPD) and supporting information from the Metrikamind project will be made available upon publication of the main results. The data will be accessible with no time limit, ensuring perpetual availability for secondary analysis and replication studies. This approach promotes ongoing scientific inquiry and verification. The data will be hosted on the Open Science Framework (OSF) and a designated institutional repository, providing access to researchers globally.
• Access Criteria: Access to the anonymized individual participant data (IPD) and supporting information from the Metrikamind project will be unrestricted. Once the data is published, it will be available to any interested researcher, practitioner, or member of the public globally. Access will be facilitated through the Open Science Framework (OSF) and a designated institutional repository, where users can freely download the data without any need for prior approval. This open access approach is intended to encourage a wide range of analyses, fostering innovation and collaboration in the field of mental health research.

Locations

ES (1)