Work-Related StressNCT07082491
Mindfulness for Reducing Work-Related Stress
A study testing Mindfulness-based stress reduction in people with Work-Related Stress and Well-being, run by University of Pavia at 1 site in Italy.
Trial summary
Work-related stress is a major contributor to absenteeism and reduces work productivity. Long-term chronic stress also has a detrimental impact on health and increases the risk of mental and physical illnesses. This underscores the urgency and need to find new approaches for the prevention and management of stress. Read more about this study
- Who is it for?
- Ages 18 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Work-Related Stress, Well-being, Inflammation Status
- What is being tested?
- Mindfulness-based stress reduction
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 120 participants
- Where
- 1 siteItaly
- Study dates
- 1 Sep 2019to 30 Mar 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
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 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Employees of the University of Siena who agree (and are motivated) to participate in the Mindfulness protocol, aged over 18 years and ≤ 65 years.
- Willingness to provide free and informed consent.
Who cannot join
- Use of psychotropic medication in the last 2 months
- Unwillingness to sign the informed consent form
- Medical conditions that prevent participation in group sessions
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Effectiveness of Mindfulness-Based Protocols in Reducing Work-Related Stress
Work-related stress is a major contributor to absenteeism and reduces work productivity. Long-term chronic stress also has a detrimental impact on health and increases the risk of mental and physical illnesses. This underscores the urgency and need to find new approaches for the prevention and management of stress. Literature studies show that Mindfulness is an innovative and effective tool for managing stress in a variety of medical, social, and educational contexts. Mindfulness can be defined as a specific form of attention focused on the present moment, intentional and non-judgmental. Growing scientific evidence supports both the use and implementation of Mindfulness-Based Interventions (MBIs) in workplace settings to improve the ability to manage work-related stress and to enhance resilience. However, despite the increasing popularity and diffusion of MBIs, the biological mechanisms underlying the beneficial effects of Mindfulness remain unclear.
The present study aims to evaluate the effectiveness of a Mindfulness-Based Stress Reduction (MBSR) program in improving physical and psychological well-being in a workplace setting (University of Siena). Specifically, this study will assess the impact of MBSR on stress reduction using an intervention adapted to the specific needs and requirements of the workplace.
Additionally, the investigators will investigate whether MBSR can influence psychological correlates and biological markers of stress (inflammatory markers) in these employees. The effectiveness of this intervention could lead to an improvement in employees' quality of life and health and to a reduction in the socioeconomic impact of stress.
Read the detailed description
Chronic stress has been associated with conditions such as diabetes (Hilliard et al., 2016), gastrointestinal diseases (Mayer, 2000), metabolic syndrome (Chandola et al., 2006), hyperthyroidism (Tsigos and Chrousos, 2002), cardiovascular diseases (Rosengren et al., 2004) and strokes caused by stressful work conditions (Huang et al., 2015). Strong experimental evidence shows the involvement of stress in mental disorders such as depression (Slavich and Irwin, 2014) and anxiety (O'Donovan et al., 2013). An individual exposed to intense and prolonged stress stimuli may experience cognitive disorders: the person has greater difficulty maintaining concentration, loses interest in work and other usual activities (hobbies, sports), and undergoes mood changes (depression, anxiety, emotional detachment, etc.). Changes are also observed in behavior, including eating disorders (such as anorexia nervosa or bulimia), and in more severe cases, obsessive-compulsive disorders (Tsigos and Chrousos, 2002).
The current regulatory framework for health and safety in the workplace has identified work-related stress as one of the main risks to the physical and mental well-being of workers. The European Commission [report by the European Agency For Safety and Health at Work (2009), European Foundation For the Improvement of Living and Working Condition (2006)] reports that work-related stress affects 22% of European workers and 27% of Italian workers. Studies carried out by the European Commission in 2002 also showed the relative economic cost of work-related stress, suggesting that 50-60% of lost workdays are due to stress, with an annual economic cost of 20 billion euros. Investing in programs that help manage and reduce work-related stress, increasing well-being, can therefore help reduce these costs and increase company productivity.
Among the practices proposed to increase resilience and improve stress management, including in the workplace, Mindfulness is an innovative and particularly effective tool. Mindfulness can be defined as a specific form of attention that is (1) focused on the present moment, (2) intentional, and (3) non-judgmental (Kabat-Zinn, 2005). Mindfulness-Based Interventions (MBIs) offer mental training that enhances our capacity for attention, concentration, and calm, developing an attitude of awareness, curiosity, openness, and acceptance of all the experiences, including negative ones. In these interventions, participants intensively practice awareness both during group sessions and through daily tasks. Moreover, practice instructions are integrated with psycho-educational content to address stress, anxiety, or depressive symptoms.
MBIs (in particular the Mindfulness-Based Stress Reduction program - MBSR) have proven effective in managing stressful events in the workplace (Hulsheger et al., 2013; Koncz et al., 2016). In recent years, MBIs have attracted the attention of industrial and organizational psychology scholars as a means to reduce workplace stress and improve employee engagement and productivity. Preliminary evidence shows positive effects on empowerment and engagement, as well as on burnout, in physicians. Their effectiveness has also been demonstrated in reducing emotional exhaustion and improving sleep quality in workers. Studies in the business field indicate that MBIs are beneficial for improving service quality, and performance levels in various tasks. Today, many large companies (such as Apple, Google, Nike, Procter \& Gamble, Deutsche Bank, General Mills, etc.) or business schools have recognized the benefits of Mindfulness in organizations and offer MBIs to their managers, employees, and students.
Despite its growing popularity, the neurobiological mechanisms underlying the health benefits of Mindfulness are still poorly understood. In a previous study, it was reported a significant increase in the thickness of the insula and somatosensory cortex in university students who completed an 8-week Mindfulness program. These areas are associated with interoception, body movement awareness, and emotional awareness. These changes were associated with a reduction in psychological indices such as worry, anxiety, and depression. Mindfulness practice, by training interoception, can improve the understanding and processing of emotional reactions to internal and external stimuli, decreasing reactivity and improving stress response.
Although many studies show that MBIs can improve symptoms related to stress, the biological mechanisms underlying the beneficial effect of Mindfulness are still not well understood. For this reason, in a preliminary study conducted on healthy subjects, it was evaluated the effect of intensive Mindfulness practice (3-day intensive) on psychological and biological parameters associated with stress (Gardi et al. Changes in salivary cytokine production in subjects attending a 3-day mindfulness retreat: a pilot study. "Second International Conference on Mindfulness", Rome 2016; Gardi C. et al. manuscript in preparation). The Mindfulness group was compared with an active control group, matched for age and sex. The intensive training significantly reduced salivary cortisol levels (the main stress hormone) and some inflammatory markers (such as IL-6 and IL-8). In the Mindfulness group, an increase in awareness and a decrease in perceived stress and anxiety were also observed. The described study is the first to document significant correlations between intensive Mindfulness practice and positive psychological changes, together with inflammatory status. These results, although preliminary, suggest that Mindfulness practice can not only help alleviate psychological distress but also contribute to improving certain inflammation biomarkers, with important implications for health.
In this project, the investigators propose a MBSR intervention which may have significant implications for employee health, their performance, and a reduction in company costs.
The present study aims to evaluate the effectiveness of this intervention in improving physical and psychological well-being in a workplace context (University of Siena). Specifically, the investigators will assess the impact of Mindfulness practice on stress reduction using an intervention tailored to the specific needs and requirements of the workplace.
Additionally, the investigators will investigate whether Mindfulness training can influence psychological correlates and biological markers of stress (inflammatory and oxidative markers) in these employees. The effectiveness of this intervention could lead to an improvement in employees' quality of life and health and to a reduction in the socioeconomic impact of stress.
Primary Endpoint: Improvement in scores from questionnaires measuring distress, burnout, and, in parallel, an increase in psychological well-being and self-awareness.
Secondary Endpoints: Reduction in stress- and inflammation-related markers (i.e., cortisol, cytokines).
Stabilization of the changes observed in participants at the end of the treatment (1-month follow-up).
- Being tested
- Mindfulness-based stress reduction
- Keywords
- mindfulness, stress, inflammation, biomarkers, employees of university, MBSR
- Medical subject headings
- Occupational Stress, Inflammation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Mindfulness-based stress reductionBehavioural
The intervention consists of 8 in-person sessions over a period of 8 weeks, with each session lasting about three hours, once per week, with an intensive full-day practice session lasting 7 hours. The instructors provide audio recordings at each session to be used as daily practice. The MBSR program is an introductory pathway to mindfulness practices that works through the systematic and continuous cultivation of specific mental states that foster a different relationship with stress.
| Study group | Role | What they receive |
|---|---|---|
| Mindfulness-based stress reduction | Experimental | Participants in this group will undergo a MBSR intervention. The intervention consists of 8 in-person sessions over 8 weeks, with each session lasting about three hours, once per week. Receives: Behavioral: Mindfulness-based stress reduction |
| Waiting-List Control Group | No intervention | Participants in this group will not receive any intervention during the study period. They will be placed on a waiting list and instructed to refrain from any meditation or mindfulness-based activities until the study is completed. This group serves as a passive control to evaluate the effectiveness of our intervention by comparing pre- and post-intervention measures. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Reduction in distress and burnout as measured by the Perceived Stress Scale (PSS) and Maslach burnout inventory (MBI)
The mprovements in scores from PSS and MBI questionnaire measuring distress and burnout, indicate enhanced psychological well-being and decreased vulnerability to chronic stress.
Measured: Baseline (T0), post-intervention (8 weeks, T1), follow-up (1 month, T2)
Secondary outcomes (4)
Improvmente in present-moment attention and awareness, as measured by the Mindful Attention Awareness Scale (MAAS)
The improvement in MAAS scores reflects enhanced moment-to-moment self-awareness and greater attentional engagement in daily experiences
Measured: Baseline (T0), post-intervention (8 weeks, T1), follow-up (1 month, T2)
Reduction of anxiety as measured by State anxiety inventory (STAI)
The decrease in STAI scores reflects a significant reduction in anxiety levels, indicating improved emotional regulation and lower acute stress in response to contextual demands.
Measured: Baseline (T0), post-intervention (8 weeks, T1), follow-up (1 month, T2)
Reduction in stress biomarker measured in saliva sample
Cortisol was assayed using standard enzyme-linked immunoassay procedures . Samples were assayed in duplicate and averaged. Lower limit of detection was 0.07 ng/ml; intra and inter-assay variation had coefficients of covariance at less than 10%. Reduction in cortisol levels indicates a decreased physiological stress response
Measured: Baseline (T0), post-intervention (8 weeks, T1), follow-up (1 month, T2)
Reduction in inflammation-related markers measured in saliva sample
Salivary concentrations of cytokines (IL-6 and IL-8) were measured according to manufacturer specifications using the Bio-Plex Pro Assays. Bio-Plex Pro Assays are immunoassays formatted on magnetic beads that utilize principles similar to those of a sandwich ELISA. Capture antibodies against the biomarker of interest are covalently coupled to the beads. A biotinylated detection antibody creates the sandwich complex, and the final detection complex is formed by the addition of a streptavidin-phycoerythrin (SA-PE) conjugate, where PE serves as the fluorescent reporter. Reactions are read using a Luminex-based reader. All assays were performed in duplicate to maximize reliability. Reduction in IL-6 and IL-8 levels indicates a decrease in systemic inflammation and immune activation.
Measured: Baseline (T0), post-intervention (8 weeks, T1), follow-up (1 month, T2)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Jul 2025
- Study start1 Sep 2019
- Primary completion30 Mar 2023
- Study completion30 Mar 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Work-Related StressStudies 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- The study involves two groups: one receiving the mindfulness-based intervention and a control group (waiting-list control). Participants are randomized into these two groups and followed in parallel without switching between conditions. The outcomes are measured before and after the intervention, comparing the effects between the two groups. Data were also collected at follow-up (1 month).
- Masking
- None (open label)
- Enrolment
- 120 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Pavia
- Sponsor type
- University, hospital or other
- Collaborators
- University of Siena
- Responsible party
- Principal investigator, Teresa Fazia, University of Pavia
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07082491
- Sponsor's protocol ID
- Mindfulness_Siena
- Status last verified
- Jul 2025
- First submitted
- 3 Jul 2025
- Last updated
- 24 Jul 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 24 Jul 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effectiveness of Mindfulness-Based Protocols in Reducing Work-Related Stress
- ClinicalTrials.gov ID
- NCT07082491
- Acronym / sponsor ID
- Mindfulness_Siena
- Keywords
- mindfulness, stress, inflammation, biomarkers, employees of university, MBSR
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 120 participants (actual)
- Lead sponsor
- University of PaviaUniversity, hospital or other
- Collaborators
- University of Siena
- Study start
- 1 Sep 2019 (actual)
- Primary completion
- 30 Mar 2023 (actual)
- Study completion
- 30 Mar 2023 (actual)
- First posted
- 24 Jul 2025 (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.
Work-related stress is a major contributor to absenteeism and reduces work productivity. Long-term chronic stress also has a detrimental impact on health and increases the risk of mental and physical illnesses. This underscores the urgency and need to find new approaches for the prevention and management of stress. Literature studies show that Mindfulness is an innovative and effective tool for managing stress in a variety of medical, social, and educational contexts. Mindfulness can be defined as a specific form of attention focused on the present moment, intentional and non-judgmental. Growing scientific evidence supports both the use and implementation of Mindfulness-Based Interventions (MBIs) in workplace settings to improve the ability to manage work-related stress and to enhance resilience. However, despite the increasing popularity and diffusion of MBIs, the biological mechanisms underlying the beneficial effects of Mindfulness remain unclear.
The present study aims to evaluate the effectiveness of a Mindfulness-Based Stress Reduction (MBSR) program in improving physical and psychological well-being in a workplace setting (University of Siena). Specifically, this study will assess the impact of MBSR on stress reduction using an intervention adapted to the specific needs and requirements of the workplace.
Additionally, the investigators will investigate whether MBSR can influence psychological correlates and biological markers of stress (inflammatory markers) in these employees. The effectiveness of this intervention could lead to an improvement in employees' quality of life and health and to a reduction in the socioeconomic impact of stress.
Detailed description
Chronic stress has been associated with conditions such as diabetes (Hilliard et al., 2016), gastrointestinal diseases (Mayer, 2000), metabolic syndrome (Chandola et al., 2006), hyperthyroidism (Tsigos and Chrousos, 2002), cardiovascular diseases (Rosengren et al., 2004) and strokes caused by stressful work conditions (Huang et al., 2015). Strong experimental evidence shows the involvement of stress in mental disorders such as depression (Slavich and Irwin, 2014) and anxiety (O'Donovan et al., 2013). An individual exposed to intense and prolonged stress stimuli may experience cognitive disorders: the person has greater difficulty maintaining concentration, loses interest in work and other usual activities (hobbies, sports), and undergoes mood changes (depression, anxiety, emotional detachment, etc.). Changes are also observed in behavior, including eating disorders (such as anorexia nervosa or bulimia), and in more severe cases, obsessive-compulsive disorders (Tsigos and Chrousos, 2002).
The current regulatory framework for health and safety in the workplace has identified work-related stress as one of the main risks to the physical and mental well-being of workers. The European Commission [report by the European Agency For Safety and Health at Work (2009), European Foundation For the Improvement of Living and Working Condition (2006)] reports that work-related stress affects 22% of European workers and 27% of Italian workers. Studies carried out by the European Commission in 2002 also showed the relative economic cost of work-related stress, suggesting that 50-60% of lost workdays are due to stress, with an annual economic cost of 20 billion euros. Investing in programs that help manage and reduce work-related stress, increasing well-being, can therefore help reduce these costs and increase company productivity.
Among the practices proposed to increase resilience and improve stress management, including in the workplace, Mindfulness is an innovative and particularly effective tool. Mindfulness can be defined as a specific form of attention that is (1) focused on the present moment, (2) intentional, and (3) non-judgmental (Kabat-Zinn, 2005). Mindfulness-Based Interventions (MBIs) offer mental training that enhances our capacity for attention, concentration, and calm, developing an attitude of awareness, curiosity, openness, and acceptance of all the experiences, including negative ones. In these interventions, participants intensively practice awareness both during group sessions and through daily tasks. Moreover, practice instructions are integrated with psycho-educational content to address stress, anxiety, or depressive symptoms.
MBIs (in particular the Mindfulness-Based Stress Reduction program - MBSR) have proven effective in managing stressful events in the workplace (Hulsheger et al., 2013; Koncz et al., 2016). In recent years, MBIs have attracted the attention of industrial and organizational psychology scholars as a means to reduce workplace stress and improve employee engagement and productivity. Preliminary evidence shows positive effects on empowerment and engagement, as well as on burnout, in physicians. Their effectiveness has also been demonstrated in reducing emotional exhaustion and improving sleep quality in workers. Studies in the business field indicate that MBIs are beneficial for improving service quality, and performance levels in various tasks. Today, many large companies (such as Apple, Google, Nike, Procter \& Gamble, Deutsche Bank, General Mills, etc.) or business schools have recognized the benefits of Mindfulness in organizations and offer MBIs to their managers, employees, and students.
Despite its growing popularity, the neurobiological mechanisms underlying the health benefits of Mindfulness are still poorly understood. In a previous study, it was reported a significant increase in the thickness of the insula and somatosensory cortex in university students who completed an 8-week Mindfulness program. These areas are associated with interoception, body movement awareness, and emotional awareness. These changes were associated with a reduction in psychological indices such as worry, anxiety, and depression. Mindfulness practice, by training interoception, can improve the understanding and processing of emotional reactions to internal and external stimuli, decreasing reactivity and improving stress response.
Although many studies show that MBIs can improve symptoms related to stress, the biological mechanisms underlying the beneficial effect of Mindfulness are still not well understood. For this reason, in a preliminary study conducted on healthy subjects, it was evaluated the effect of intensive Mindfulness practice (3-day intensive) on psychological and biological parameters associated with stress (Gardi et al. Changes in salivary cytokine production in subjects attending a 3-day mindfulness retreat: a pilot study. "Second International Conference on Mindfulness", Rome 2016; Gardi C. et al. manuscript in preparation). The Mindfulness group was compared with an active control group, matched for age and sex. The intensive training significantly reduced salivary cortisol levels (the main stress hormone) and some inflammatory markers (such as IL-6 and IL-8). In the Mindfulness group, an increase in awareness and a decrease in perceived stress and anxiety were also observed. The described study is the first to document significant correlations between intensive Mindfulness practice and positive psychological changes, together with inflammatory status. These results, although preliminary, suggest that Mindfulness practice can not only help alleviate psychological distress but also contribute to improving certain inflammation biomarkers, with important implications for health.
In this project, the investigators propose a MBSR intervention which may have significant implications for employee health, their performance, and a reduction in company costs.
The present study aims to evaluate the effectiveness of this intervention in improving physical and psychological well-being in a workplace context (University of Siena). Specifically, the investigators will assess the impact of Mindfulness practice on stress reduction using an intervention tailored to the specific needs and requirements of the workplace.
Additionally, the investigators will investigate whether Mindfulness training can influence psychological correlates and biological markers of stress (inflammatory and oxidative markers) in these employees. The effectiveness of this intervention could lead to an improvement in employees' quality of life and health and to a reduction in the socioeconomic impact of stress.
Primary Endpoint: Improvement in scores from questionnaires measuring distress, burnout, and, in parallel, an increase in psychological well-being and self-awareness.
Secondary Endpoints: Reduction in stress- and inflammation-related markers (i.e., cortisol, cytokines).
Stabilization of the changes observed in participants at the end of the treatment (1-month follow-up).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- The study involves two groups: one receiving the mindfulness-based intervention and a control group (waiting-list control). Participants are randomized into these two groups and followed in parallel without switching between conditions. The outcomes are measured before and after the intervention, comparing the effects between the two groups. Data were also collected at follow-up (1 month).
| Arm | Type | Receives |
|---|---|---|
| Mindfulness-based stress reduction | Experimental | Behavioral: Mindfulness-based stress reductionParticipants in this group will undergo a MBSR intervention. The intervention consists of 8 in-person sessions over 8 weeks, with each session lasting about three hours, once per week. |
| Waiting-List Control Group | No intervention | –Participants in this group will not receive any intervention during the study period. They will be placed on a waiting list and instructed to refrain from any meditation or mindfulness-based activities until the study is completed. This group serves as a passive control to evaluate the effectiveness of our intervention by comparing pre- and post-intervention measures. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Employees of the University of Siena who agree (and are motivated) to participate in the Mindfulness protocol, aged over 18 years and ≤ 65 years.
- Willingness to provide free and informed consent.
Key exclusion criteria (3 listed)
- Use of psychotropic medication in the last 2 months
- Unwillingness to sign the informed consent form
- Medical conditions that prevent participation in group sessions
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 |
|---|---|---|
| Mindfulness-based stress reductionThe intervention consists of 8 in-person sessions over a period of 8 weeks, with each session lasting about three hours, once per week, with an intensive full-day practice session lasting 7 hours. The instructors provide audio recordings at each session to be used as daily practice. The MBSR program is an introductory pathway to mindfulness practices that works through the systematic and continuous cultivation of specific mental states that foster a different relationship with stress. | Behavioural | Mindfulness-based stress reduction |
Primary outcome
Reduction in distress and burnout as measured by the Perceived Stress Scale (PSS) and Maslach burnout inventory (MBI)
Time frame: Baseline (T0), post-intervention (8 weeks, T1), follow-up (1 month, T2)
The mprovements in scores from PSS and MBI questionnaire measuring distress and burnout, indicate enhanced psychological well-being and decreased vulnerability to chronic stress.
4 secondary outcomes
Improvmente in present-moment attention and awareness, as measured by the Mindful Attention Awareness Scale (MAAS)
Time frame: Baseline (T0), post-intervention (8 weeks, T1), follow-up (1 month, T2)
Reduction of anxiety as measured by State anxiety inventory (STAI)
Time frame: Baseline (T0), post-intervention (8 weeks, T1), follow-up (1 month, T2)
Reduction in stress biomarker measured in saliva sample
Time frame: Baseline (T0), post-intervention (8 weeks, T1), follow-up (1 month, T2)
Reduction in inflammation-related markers measured in saliva sample
Time frame: Baseline (T0), post-intervention (8 weeks, T1), follow-up (1 month, T2)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Jul 2025.
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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. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Mindfulness-based stress reduction in people with Work-Related Stress and Well-being, run by University of Pavia at 1 site in Italy.
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 2 inclusion and 3 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: finished, as of the sponsor's last update on 24 Jul 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 Italy. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Reduction in distress and burnout as measured by the Perceived Stress Scale (PSS) and Maslach burnout inventory (MBI) (time frame: Baseline (T0), post-intervention (8 weeks, T1), follow-up (1 month, T2)). 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 24 Jul 2025.