Mindfulness for Reducing Work-Related Stress

NCT07082491 | Completed DMC

• 1 other identifier: Mindfulness_Siena
• Study Type: interventional
• Target: 120
• Locations: 1 country
• Sites: 1

Brief 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. 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.

Conditions

Work-Related Stress; Well-being; Inflammation Status; Employees of University

Keywords

mindfulness; stress; inflammation; biomarkers; employees of university; MBSR

Outcome Measures

Primary Outcomes (1)

• 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.

  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)

  Baseline (T0), post-intervention (8 weeks, T1), follow-up (1 month, T2)

• Reduction of anxiety as measured by State anxiety inventory (STAI)

  Baseline (T0), post-intervention (8 weeks, T1), follow-up (1 month, T2)

• Reduction in stress biomarker measured in saliva sample

  Baseline (T0), post-intervention (8 weeks, T1), follow-up (1 month, T2)

• Reduction in inflammation-related markers measured in saliva sample

  Baseline (T0), post-intervention (8 weeks, T1), follow-up (1 month, T2)

Study Arms (2)

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.

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.

Interventions

Mindfulness-based stress reduction BEHAVIORAL

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.

Mindfulness-based stress reduction

Eligibility Criteria

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

You may qualify if:

• 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.

You may not qualify if:

• Use of psychotropic medication in the last 2 months
• Unwillingness to sign the informed consent form
• Medical conditions that prevent participation in group sessions

Sponsors & Collaborators

• University of Pavia: lead
• University of Siena, Italy: collaborator

Study Sites (1)

University of Siena

Siena, 53100, Italy

Location

MeSH Terms

Conditions

Occupational Stress; Inflammation

Interventions

Mindfulness-Based Stress Reduction

Condition Hierarchy (Ancestors)

Occupational Diseases; Stress, Psychological; Behavioral Symptoms; Behavior; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Mindfulness; Cognitive Behavioral Therapy; Behavior Therapy; Psychotherapy; Behavioral Disciplines and Activities

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigato

Model Details: 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).

Study Record Dates

• First Submitted: July 3, 2025
• First Posted: July 24, 2025
• Study Start: September 1, 2019
• Primary Completion: March 30, 2023
• Study Completion: March 30, 2023
• Last Updated: July 24, 2025

Record last verified: 2025-07

Locations

IT (1)