CompletedNot Applicable

Effect of Mindfulness-Based Protocols on Psychological Parameters and Biological Markers in Populations Exposed to Conditions of Persistent Distress

Italy100 participantsStarted 2020-10-10

Plain-language 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. 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

Who can participate

Age range

18 Years – 65 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion Criteria: * 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 Exclusion Criteria: * Use of psychotropic drugs in the previous 2 months * Previous mindfulness training * Medical conditions preventing participation in group sessions * Current pregnancy.

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Cortisol level

Timeframe: At baseline before the intervention (T0), after the 8-week intervention (T1), and at follow-up after 6 months (T2)

Trial details

NCT IDNCT07129057

SponsorAzienda Unita Sanitaria Locale di Piacenza

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2024-09-30

View on ClinicalTrials.gov More Distress, Psychological trials