Depression DisordersMetrikaMindNCT06650176
METRIKAMIND - Development of a Digital Mental Health Ecosystem for Workplace Environments
An observational study of Depression Disorders and Anxiety, run by David Gallardo-Pujol at 1 site in Spain.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Depression Disorders, Anxiety
- What is being tested?
- Lifestyle Management
- Type of treatment
- Lifestyle or therapy programme
- How many people
- 400 participants
- Where
- 1 siteSpain
- Study dates
- 30 Sep 2025to 30 Apr 2026
- How long will I take part?
- 6 Months
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
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 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
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.
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Spain1 site
Faculty of Psychology
Barcelona, Barcelona, 08035
Vicedegà de Recerca, PhD, +34933125010, vd.psicologia.recerca@ub.edu
David Gallardo-Pujol, PhD in Clinical Psychology
About this study
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?
Read more
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.
Read the detailed description
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:
This observational study will utilize a longitudinal design, where participants will interact with the Metrikamind platform over a period of six months. The study will recruit adult employees from various sectors to ensure a diverse participant pool that reflects a wide range of work environments. Participants will use the platform to complete regular mental health assessments, which include both quantitative and qualitative measures.
Methods:
Participants will be asked to engage with a series of assessments developed based on bifactor models, which are designed to detect and mitigate the effects of faking and social desirability bias in self-report assessments. These models improve the accuracy and reliability of mental health assessments by allowing for the separation of specific factors from general mental health constructs, thereby enhancing the precision of diagnosis and intervention.
Each participant will complete a baseline assessment upon enrollment, followed by monthly follow-up assessments through the platform. The assessments will cover various aspects of mental health, including stress, anxiety, depression, and overall emotional well-being. Additional data on work performance and engagement will be collected through integrations with workplace productivity tools where available.
Data Analysis:
Data collected will be analyzed using advanced statistical techniques to determine the effectiveness of the digital platform in improving mental health outcomes. Analysis will include the use of longitudinal data analysis methods to track changes in mental health over time and to identify predictors of improvement or deterioration. Correlational analysis will also be employed to explore the relationships between mental health data and workplace productivity metrics.
Innovative Components:
The Metrikamind project incorporates several innovative aspects:
Use of Bifactor Models: By applying bifactor models, the project stands at the forefront of psychometric innovation, offering more nuanced insights into mental health assessments.
Real-Time Data Analytics: The platform provides real-time analytics, allowing both participants and supervisors (with consent) to monitor mental health status and intervene when necessary promptly.
Integration with Work Tools: Integration with existing workplace tools and platforms ensures that the mental health management system fits seamlessly into the daily routines of employees, thereby enhancing usability and compliance.
Ethical Considerations:
All participants will provide informed consent before participating in the study. The study will adhere to the ethical guidelines laid out by the EU Regulation 2016/679 (GDPR) and the Organic Data Protection Law 3/2018, ensuring the highest standards of data privacy and security. All data will be anonymized, and personal identifiers will be removed before analysis to maintain confidentiality.
Expected Outcomes:
The Metrikamind project is expected to demonstrate the efficacy of digital tools in managing workplace mental health. It aims to provide empirical evidence supporting the integration of such tools into standard workplace practices, potentially leading to a paradigm shift in how mental health is managed at work.
Conclusion:
By advancing our understanding of digital health applications in the workplace, the Metrikamind project promises to make a significant impact on the field of occupational health psychology, offering new avenues for promoting mental health at work.
- Conditions
- Depression Disorders, Anxiety
- Being tested
- Lifestyle Management
- Keywords
- depression, anxiety, workplace, faking good, faking bad, psychometrics, absenteeism, presentism
- Medical subject headings
- Anxiety Disorders, Depression
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Lifestyle ManagementBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Behavioral: Lifestyle Management |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: Six Months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Oct 2024
- Study start30 Sep 2025 (estimated)
- Primary completion30 Apr 2026 (estimated)
- Study completion30 Apr 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Depression DisordersStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Ecologic or community
- Time perspective
- Prospective
- Enrolment
- 400 participants (estimated)
- Target duration
- 6 Months
Sponsor and investigators
- Lead sponsor
- David Gallardo-Pujol
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, David Gallardo-Pujol, University of Barcelona
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06650176
- Sponsor's protocol ID
- CPP2021-008590
- Acronym
- MetrikaMind
- Status last verified
- Mar 2025
- First submitted
- 1 Oct 2024
- Last updated
- 27 Mar 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: The investigators commit to the open sharing of all collected IPD that underlie the results reported in our publications, subject to ensuring privacy and confidentiality. All IPD will be thoroughly anonymized to remove personal identifiers, ensuring compliance with GDPR and other relevant data protection regulations. The anonymized datasets, along with the associated metadata, study protocol, statistical analysis plan, and other relevant study materials, will be made available in an institutional repository and on the Open Science Framework (OSF) following the completion of the study and the publication of primary outcomes. This approach supports the replication of our research and contributes to the broader scientific community by providing access to high-quality data for further analysis. Sharing these data aligns with current best practices in psychological research, promoting transparency, reproducibility, and the ethical use of information for scientific inquiry.
Study at a glance
From the registry record, last updated by the sponsor on 27 Mar 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- METRIKAMIND - Development of a Digital Mental Health Ecosystem for Workplace Environments
- ClinicalTrials.gov ID
- NCT06650176
- Acronym / sponsor ID
- MetrikaMind / CPP2021-008590
- Conditions
- Depression Disorders, Anxiety
- Keywords
- depression, anxiety, workplace, faking good, faking bad, psychometrics, absenteeism, presentism
- Study type
- Observational
- Recruitment status
- Not yet recruiting
- Enrolment
- 400 participants (estimated)
- Lead sponsor
- David Gallardo-PujolUniversity, hospital or other
- Study start
- 30 Sep 2025 (estimated)
- Primary completion
- 30 Apr 2026 (estimated)
- Study completion
- 30 Apr 2026 (estimated)
- First posted
- 21 Oct 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
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:
This observational study will utilize a longitudinal design, where participants will interact with the Metrikamind platform over a period of six months. The study will recruit adult employees from various sectors to ensure a diverse participant pool that reflects a wide range of work environments. Participants will use the platform to complete regular mental health assessments, which include both quantitative and qualitative measures.
Methods:
Participants will be asked to engage with a series of assessments developed based on bifactor models, which are designed to detect and mitigate the effects of faking and social desirability bias in self-report assessments. These models improve the accuracy and reliability of mental health assessments by allowing for the separation of specific factors from general mental health constructs, thereby enhancing the precision of diagnosis and intervention.
Each participant will complete a baseline assessment upon enrollment, followed by monthly follow-up assessments through the platform. The assessments will cover various aspects of mental health, including stress, anxiety, depression, and overall emotional well-being. Additional data on work performance and engagement will be collected through integrations with workplace productivity tools where available.
Data Analysis:
Data collected will be analyzed using advanced statistical techniques to determine the effectiveness of the digital platform in improving mental health outcomes. Analysis will include the use of longitudinal data analysis methods to track changes in mental health over time and to identify predictors of improvement or deterioration. Correlational analysis will also be employed to explore the relationships between mental health data and workplace productivity metrics.
Innovative Components:
The Metrikamind project incorporates several innovative aspects:
Use of Bifactor Models: By applying bifactor models, the project stands at the forefront of psychometric innovation, offering more nuanced insights into mental health assessments.
Real-Time Data Analytics: The platform provides real-time analytics, allowing both participants and supervisors (with consent) to monitor mental health status and intervene when necessary promptly.
Integration with Work Tools: Integration with existing workplace tools and platforms ensures that the mental health management system fits seamlessly into the daily routines of employees, thereby enhancing usability and compliance.
Ethical Considerations:
All participants will provide informed consent before participating in the study. The study will adhere to the ethical guidelines laid out by the EU Regulation 2016/679 (GDPR) and the Organic Data Protection Law 3/2018, ensuring the highest standards of data privacy and security. All data will be anonymized, and personal identifiers will be removed before analysis to maintain confidentiality.
Expected Outcomes:
The Metrikamind project is expected to demonstrate the efficacy of digital tools in managing workplace mental health. It aims to provide empirical evidence supporting the integration of such tools into standard workplace practices, potentially leading to a paradigm shift in how mental health is managed at work.
Conclusion:
By advancing our understanding of digital health applications in the workplace, the Metrikamind project promises to make a significant impact on the field of occupational health psychology, offering new avenues for promoting mental health at work.
Study design
- Observational model
- Ecologic or community
- Time perspective
- Prospective
- Target follow-up
- 6 Months
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Workers on sick leave | – | Behavioral: Lifestyle ManagementThis 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. |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (4 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Lifestyle ManagementThe 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. | Behavioural | Workers on sick leave |
Primary outcome
Battery of Psychological Assessment (PHQ9)
Time frame: 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)
Time frame: 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)
Time frame: 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)
Time frame: 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)
Time frame: 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)
Time frame: 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.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Mar 2025.
- Individual participant dataSharing planned: Yes. The investigators commit to the open sharing of all collected IPD that underlie the results reported in our publications, subject to ensuring privacy and confidentiality. All IPD will be thoroughly anonymized to remove personal identifiers, ensuring compliance with GDPR and other relevant data protection regulations. The anonymized datasets, along with the associated metadata, study protocol, statistical analysis plan, and other relevant study materials, will be made available in an institutional repository and on the Open Science Framework (OSF) following the completion of the study and the publication of primary outcomes. This approach supports the replication of our research and contributes to the broader scientific community by providing access to high-quality data for further analysis. Sharing these data aligns with current best practices in psychological research, promoting transparency, reproducibility, and the ethical use of information for scientific inquiry.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Depression Disorders and Anxiety, run by David Gallardo-Pujol at 1 site in Spain.
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 4 inclusion and 4 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: opening soon, as of the sponsor's last update on 27 Mar 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Spain. Whether a site is taking part right now should be confirmed with that site. See every site.
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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact David Gallardo-Pujol, PhD in Clinical Psychology (34 93 312 58 65, david.gallardo@ub.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Battery of Psychological Assessment (PHQ9) (time frame: Six Months). The study lists 6 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 27 Mar 2025.