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

NCT07129057 | Completed

• 1 other identifier: MINDFULNESS-BASED
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 1

Brief 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

Conditions

Distress, Psychological

Keywords

Attention and awareness; Clinical psychology; Mindfulness; Randomized Controlled Trial; Stress biomarkers

Outcome Measures

Primary Outcomes (1)

• 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).

  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)

  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)

  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)

  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)

  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)

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

Study Arms (2)

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.

Other: MBSR program

Control

NO INTERVENTION

No attending to the MBSR program

Interventions

MBSR program OTHER

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.

MBSR program

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• Use of psychotropic drugs in the previous 2 months
• Previous mindfulness training
• Medical conditions preventing participation in group sessions
• Current pregnancy.

Sponsors & Collaborators

• Azienda Unita Sanitaria Locale di Piacenza: lead
• University of Siena, Italy: collaborator

Study Sites (1)

Liaison Psychiatry and Social Inclusion Unit of the Local Health Unit ("Azienda Unità Sanitaria Locale", AUSL) of Piacenza

Piacenza, 29121, Italy

Location

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 25, 2025
• First Posted: August 19, 2025
• Study Start: October 10, 2020
• Primary Completion: September 30, 2024
• Study Completion: September 30, 2024
• Last Updated: August 19, 2025

Record last verified: 2025-08

Data Sharing

• IPD Sharing: Will not share

Locations

IT (1)