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

NCT ID: NCT07129057

Last Updated: 2025-08-19

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 100 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2020-10-10
• Study Completion Date: 2024-09-30

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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: PREVENTION
• Blinding Strategy: NONE

Study Groups

MBSR program

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.

Group Type: EXPERIMENTAL

MBSR program

Intervention Type: 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.

Control

No attending to the MBSR program

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

MBSR program

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.

Intervention Type: OTHER

Eligibility Criteria

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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Azienda Unita Sanitaria Locale di Piacenza

OTHER

Sponsor Role: lead

University of Siena, Italy

UNKNOWN

Sponsor Role: collaborator

Responsible Party

Responsibility Role: SPONSOR

Locations

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

Piacenza, , Italy

Countries

Italy

Other Identifiers

MINDFULNESS-BASED

Identifier Type: -

Identifier Source: org_study_id