Distress, PsychologicalNCT07129057
Effect of Mindfulness-Based Protocols on Psychological Parameters and Biological Markers in Populations Exposed to Conditions of Persistent Distress
A study testing MBSR program in people with Distress, Psychological, run by Azienda Unita Sanitaria Locale di Piacenza at 1 site in Italy.
Trial summary
The goal of this clinical trial is to learn if a Mindfulness-Based Stress Reduction (MBSR) training can improve the mental health and well-being of healthcare professionals (HCPs) exposed to prolonged severe stress conditions. Read more about this study
- Who is it for?
- Ages 18 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Distress, Psychological
- What is being tested?
- MBSR program
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- 1 siteItaly
- Study dates
- 10 Oct 2020to 30 Sep 2024
- 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
- Healthcare workers belonging to the Dept. of Mental Health, Onco-hematology, Medicine, and Intensive Care, who are frequently exposed to situations of severe and prolonged stress
- age between 18 and 65 years
- informed consent
Who cannot join
- Use of psychotropic drugs in the previous 2 months
- Previous mindfulness training
- Medical conditions preventing participation in group sessions
- Current pregnancy.
Trial locations and contacts
1 site in 1 country.
Italy1 site
Liaison Psychiatry and Social Inclusion Unit of the Local Health Unit ("Azienda Unità Sanitaria Locale", AUSL) of Piacenza
Piacenza, 29121
About this study
Official title: Effect of Mindfulness-Based Protocols on Psychological Parameters and Biological Markers in Populations Exposed to Conditions of Persistent Distress: a Randomized Controlled Trial in Healthcare Workers
The goal of this clinical trial is to learn if a Mindfulness-Based Stress Reduction (MBSR) training can improve the mental health and well-being of healthcare professionals (HCPs) exposed to prolonged severe stress conditions.
The main questions it aims to answer are:
Read more
- Does an 8-week MBSR training lower the cortisol levels of HCPs exposed to prolonged severe stress conditions?
- Does an 8-week MBSR training modify the psychological condition of HCPs exposed to prolonged severe stress conditions? Researchers will compare an 8-week MBSR training to no-training to see if MBSR training works to improve the mental health and well-being of HCPs.
Participants will:
- Partecipate or not partecipate to the MBSR training for 8 weeks
- Visit the clinic at baseline, after the 8-week intervention (T1), and at follow-up after 6 months for checkups and tests
- Conditions
- Distress, Psychological
- Being tested
- MBSR program
- Keywords
- Attention and awareness, Clinical psychology, Mindfulness, Randomized Controlled Trial, Stress biomarkers
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MBSR programOther
The MBSR program lasts eight consecutive weeks (two months), with group sessions lasting two and a half hours each and an intensive 8-hour full-day practice session. At each session, the participants receive audio tracks for daily home practice.
| Study group | Role | What they receive |
|---|---|---|
| MBSR program | Experimental | The MBSR program is an introductory course to mindfulness practices that operate through the systematic and continuous cultivation of specific mental states that promote a different relationship with stress and discomfort. Receives: Other: MBSR program |
| Control | No intervention | No attending to the MBSR program |
What is being measured
The primary outcome is the main question the study is designed to answer.
Cortisol level
To assess cortisol levels, at baseline (T0), T1, and T2, saliva samples will be collected using Salivettes (Sarstedt) 30 minutes after waking up. Participants will be instructed not to drink, eat, chew gum, or brush their teeth in the 30 minutes preceding the sample collection. To collect the saliva, participants will be advised to rinse their mouth with water for 30 seconds, wait 10 minutes, and then remove the swab from the Salivette and chew it for about 2 minutes to stimulate salivation. The swab will be reinserted into the Salivette, frozen at -20°C and stored at the Laboratory of the AUSL Piacenza Centre. Then, sample will be shipped to the University of Siena for further analysis. Upon arrival at the laboratory, the samples will be thawed and centrifuged at 2000 × g for 5 minutes at 4°C. Salivary cortisol levels will be assayed by an Enzyme Immunoassay kit (Arbor Assays Inc., Ann Arbor, Michigan, USA).
Measured: At baseline before the intervention (T0), after the 8-week intervention (T1), and at follow-up after 6 months (T2)
Secondary outcomes (7)
Psychometric evaluation of stress and burnout by Job Strain subscale of the Italian Cardiologists' Undetected Distress Study (IANUS)
The IANUS consists of 15 items for measuring 4 main factors. Items are scored on a Likert-type response scale (never=1; sometimes=2; often=3; almost always=4). The score of the Job Strain 5-item subscale ranges from 0 to 100 [sum of item scores *100/(4*5)], with higher values corresponding to greater job strain.
Measured: At baseline before the intervention (T0), after the 8-week intervention (T1), and at follow-up after 6 months (T2)
Psychometric evaluation of stress and burnout by Positive Meaning subscale of the Italian Cardiologists' Undetected Distress Study (IANUS)
The IANUS consists of 15 items for measuring 4 main factors. Items are scored on a Likert-type response scale (never=1; sometimes=2; often=3; almost always=4). The score of the Positive Meaning 4-item subscale ranges from 0 to 100 [sum of item scores *100/(4*4)], with higher values corresponding to greater positive meaning of work by the partecipant.
Measured: At baseline before the intervention (T0), after the 8-week intervention (T1), and at follow-up after 6 months (T2)
Psychometric evaluation of stress and burnout by Emotional Fatigue subscale ofthe Italian Cardiologists' Undetected Distress Study (IANUS)
The IANUS consists of 15 items for measuring 4 main factors. Items are scored on a Likert-type response scale (never=1; sometimes=2; often=3; almost always=4). The score of the Emotional Fatigue 3-item subscale ranges from 0 to 100 [sum of item scores *100/(4*3)], with higher values corresponding to greater emotional fatigue of the partecipant.
Measured: At baseline before the intervention (T0), after the 8-week intervention (T1), and at follow-up after 6 months (T2)
Psychometric evaluation of stress and burnout by Relational Difficulty subscale of the Italian Cardiologists' Undetected Distress Study (IANUS)
The IANUS consists of 15 items for measuring 4 main factors. Items are scored on a Likert-type response scale (never=1; sometimes=2; often=3; almost always=4). The score of the Relational Difficulty 3-item subscale ranges from 0 to 100 [sum of item scores *100/(4*3)], with higher values corresponding to greater relational difficulties by the partecipant.
Measured: At baseline before the intervention (T0), after the 8-week intervention (T1), and at follow-up after 6 months (T2)
Psychometric evaluation of stress and burnout by the Perceived Stress Scale (PSS)
The PSS measures the degree to which situations in a person's life are appraised as stressful. Each item was rated by the subject on a scale ranging from 0 (never) to 4 (very often). The scale values range from 0 to 40, with a higher score indicating a higher degree of subjective stress. Total scores 0-13 are considered low perceived stress, 14-26 as moderate perceived stress, and 27-40 as high perceived stress.
Measured: At baseline before the intervention (T0), after the 8-week intervention (T1), and at follow-up after 6 months (T2)
Psychometric evaluation of awareness and mindfulness skills by the Mindfulness Awareness Attention Scale (MAAS)
The MAAS is a 15-item scale investigating awareness and attention to what is happening in the present. The MAAS is a 15-item self-report instrument designed to measure dispositional mindfulness, specifically the frequency of open or receptive attention to and awareness of present-moment experiences. Participants rate each item (e.g., "I find it difficult to stay focused on what's happening in the present") on a 6-point Likert scale ranging from 1 (almost always) to 6 (almost never), with higher scores indicating greater mindfulness. The MAAS has demonstrated high internal consistency and good psychometric properties in both clinical and non-clinical populations.
Measured: At baseline before the intervention (T0), after the 8-week intervention (T1), and at follow-up after 6 months (T2)
Psychometric evaluation of psychophysiological distress and quality of life by the Psychological General Well-Being Short (PGWB-S)
PGWB-S is a 6-item, rated on a 6-point scale, health-related Quality of Life questionnaire derived from the 22-item Psychological General Well-Being Index, developed in the United States. It produces a self-perceived evaluation of psychological well-being expressed by a summary score, which reaches a maximum of 30 points, representing the best achievable "well being".
The PGWB-S showed good acceptability and validity for use in various settings in Italy.
Measured: At baseline before the intervention (T0), after the 8-week intervention (T1), and at follow-up after 6 months (T2)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Aug 2025
- Study start10 Oct 2020
- Primary completion30 Sep 2024
- Study completion30 Sep 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Distress, PsychologicalStudies 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
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 100 participants (actual)
Sponsor and investigators
- Lead sponsor
- Azienda Unita Sanitaria Locale di Piacenza
- Sponsor type
- University, hospital or other
- Collaborators
- University of Siena
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07129057
- Sponsor's protocol ID
- MINDFULNESS-BASED
- Status last verified
- Aug 2025
- First submitted
- 25 Jul 2025
- Last updated
- 19 Aug 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 19 Aug 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Mindfulness-Based Protocols on Psychological Parameters and Biological Markers in Populations Exposed to Conditions of Persistent Distress: a Randomized Controlled Trial in Healthcare Workers
- ClinicalTrials.gov ID
- NCT07129057
- Acronym / sponsor ID
- MINDFULNESS-BASED
- Conditions
- Distress, Psychological
- Keywords
- Attention and awareness, Clinical psychology, Mindfulness, Randomized Controlled Trial, Stress biomarkers
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 100 participants (actual)
- Lead sponsor
- Azienda Unita Sanitaria Locale di PiacenzaUniversity, hospital or other
- Collaborators
- University of Siena
- Study start
- 10 Oct 2020 (actual)
- Primary completion
- 30 Sep 2024 (actual)
- Study completion
- 30 Sep 2024 (actual)
- First posted
- 19 Aug 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.
The goal of this clinical trial is to learn if a Mindfulness-Based Stress Reduction (MBSR) training can improve the mental health and well-being of healthcare professionals (HCPs) exposed to prolonged severe stress conditions.
The main questions it aims to answer are:
- Does an 8-week MBSR training lower the cortisol levels of HCPs exposed to prolonged severe stress conditions?
- Does an 8-week MBSR training modify the psychological condition of HCPs exposed to prolonged severe stress conditions? Researchers will compare an 8-week MBSR training to no-training to see if MBSR training works to improve the mental health and well-being of HCPs.
Participants will:
- Partecipate or not partecipate to the MBSR training for 8 weeks
- Visit the clinic at baseline, after the 8-week intervention (T1), and at follow-up after 6 months for checkups and tests
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| MBSR program | Experimental | Other: MBSR programThe MBSR program is an introductory course to mindfulness practices that operate through the systematic and continuous cultivation of specific mental states that promote a different relationship with stress and discomfort. |
| Control | No intervention | –No attending to the MBSR program |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Healthcare workers belonging to the Dept. of Mental Health, Onco-hematology, Medicine, and Intensive Care, who are frequently exposed to situations of severe and prolonged stress
- age between 18 and 65 years
- informed consent
Key exclusion criteria (4 listed)
- Use of psychotropic drugs in the previous 2 months
- Previous mindfulness training
- Medical conditions preventing participation in group sessions
- Current pregnancy.
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 |
|---|---|---|
| MBSR programThe MBSR program lasts eight consecutive weeks (two months), with group sessions lasting two and a half hours each and an intensive 8-hour full-day practice session. At each session, the participants receive audio tracks for daily home practice. | Other | MBSR program |
Primary outcome
Cortisol level
Time frame: At baseline before the intervention (T0), after the 8-week intervention (T1), and at follow-up after 6 months (T2)
To assess cortisol levels, at baseline (T0), T1, and T2, saliva samples will be collected using Salivettes (Sarstedt) 30 minutes after waking up. Participants will be instructed not to drink, eat, chew gum, or brush their teeth in the 30 minutes preceding the sample collection. To collect the saliva, participants will be advised to rinse their mouth with water for 30 seconds, wait 10 minutes, and then remove the swab from the Salivette and chew it for about 2 minutes to stimulate salivation. The swab will be reinserted into the Salivette, frozen at -20°C and stored at the Laboratory of the AUSL Piacenza Centre. Then, sample will be shipped to the University of Siena for further analysis. Upon arrival at the laboratory, the samples will be thawed and centrifuged at 2000 × g for 5 minutes at 4°C. Salivary cortisol levels will be assayed by an Enzyme Immunoassay kit (Arbor Assays Inc., Ann Arbor, Michigan, USA).
7 secondary outcomes
Psychometric evaluation of stress and burnout by Job Strain subscale of the Italian Cardiologists' Undetected Distress Study (IANUS)
Time frame: At baseline before the intervention (T0), after the 8-week intervention (T1), and at follow-up after 6 months (T2)
Psychometric evaluation of stress and burnout by Positive Meaning subscale of the Italian Cardiologists' Undetected Distress Study (IANUS)
Time frame: At baseline before the intervention (T0), after the 8-week intervention (T1), and at follow-up after 6 months (T2)
Psychometric evaluation of stress and burnout by Emotional Fatigue subscale ofthe Italian Cardiologists' Undetected Distress Study (IANUS)
Time frame: At baseline before the intervention (T0), after the 8-week intervention (T1), and at follow-up after 6 months (T2)
Psychometric evaluation of stress and burnout by Relational Difficulty subscale of the Italian Cardiologists' Undetected Distress Study (IANUS)
Time frame: At baseline before the intervention (T0), after the 8-week intervention (T1), and at follow-up after 6 months (T2)
Psychometric evaluation of stress and burnout by the Perceived Stress Scale (PSS)
Time frame: At baseline before the intervention (T0), after the 8-week intervention (T1), and at follow-up after 6 months (T2)
Psychometric evaluation of awareness and mindfulness skills by the Mindfulness Awareness Attention Scale (MAAS)
Time frame: At baseline before the intervention (T0), after the 8-week intervention (T1), and at follow-up after 6 months (T2)
Psychometric evaluation of psychophysiological distress and quality of life by the Psychological General Well-Being Short (PGWB-S)
Time frame: At baseline before the intervention (T0), after the 8-week intervention (T1), and at follow-up after 6 months (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 19 Aug 2025.
- Individual participant dataSharing planned: No
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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 MBSR program in people with Distress, Psychological, run by Azienda Unita Sanitaria Locale di Piacenza 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 3 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: finished, as of the sponsor's last update on 19 Aug 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?
Cortisol level (time frame: At baseline before the intervention (T0), after the 8-week intervention (T1), and at follow-up after 6 months (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 19 Aug 2025.