Mindfulness-based Stress Reduction (MBSR) for Reduction of Chronic Pain and Drug Therapie (Chronicare)

Mindfulness-based Stress Reduction or Usual Treatment for Treatment of Chronic Pain in an Italian Hospital

Mindfulness-Based Cognitive Therapy (MBCT) combines ideas of traditional cognitive therapies with meditative practices aimed at cultivating mindfulness. Mindfulness-based stress reduction (MBSR) is considered one of the original mindfulness-based interventions. It has been modified to be offered virtually,which has been useful throughout the COVID pandemic, and more importantly, has served to inform other mindfulness approaches, such as trauma-focused therapy. The investigators want to assess the efficacy of MBSR in patients with Chronic Pain undergoing drug treatment.

Study Overview

• Status: Recruiting
• Conditions: Chronic Pain
• Intervention / Treatment: Behavioral: Mindfulness-based stress reduction (MBSR)

Detailed Description

Mindfulness helps develop the ability to observe and detach from our mental, sensory, and emotional states, and thus increases our awareness and ability to manage emotions.

In the experimental arm, some have been foreseen group sessions, in which a maximum of ten people participate on the Mindfulness-based stress reduction (MBSR).

The protocol provides for eight meetings (one and a half or two hours each) on a monthly basis, for a total duration, therefore, of twelve months.

• Study Type: Interventional
• Enrollment (Estimated): 200
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Vincenzo Damico; Phone Number: +39 3409297118; Email: vi.damico@asst-lecco.it
• Study Contact Backup: Name: Vincenzo Damico; Phone Number: + 39 3409297118; Email: vi.damico@asst-lecco.it

Study Locations

• Italy
  • Lecco, Italy, 23814
    • Recruiting
    • ASST Lecco
    • Contact: VINCENZO LC DAMICO; Phone Number: LC 3409297118; Email: vi.damico@asst-lecco.it

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• Patients being treated for Chronic Pain
• Patients with Chronic Pain in Pharmacological Therapy

Exclusion Criteria:

• Patients with Chronic Pain not in Pharmacological Therapy
• Patients without Chronic Pain

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Crossover Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
No Intervention: Control; Normal drug therapie or usual treatment
Experimental: Intervention; Normal drug therapie or usual treatment with add Mindfulness-based stress reduction (MBSR)	Behavioral: Mindfulness-based stress reduction (MBSR); Mindfulness-based stress reduction may be associated with short-term effects on pain intensity and physical functioning. Patients will be randomized into 2 groups. The experimental group will receive MBSR sessions, with the frequency and duration specified in the study protocol. The sessions will be free and carried out by expert staff

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Chronic pain assessed with the Brief Pain Inventory (BPI)	Chronic or persistent pain is pain that carries on for longer than 12 weeks despite medication or treatment.	1 year

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Quality of life assessore with EQ5D	Perceived quality of life in the 5 dimension of EQ5D	1 year
Drug assumption	Drug or therapy assumption by the patient for pain treatment	1 year

Collaborators and Investigators

• Sponsor: Azienda Socio Sanitaria Territoriale di Lecco
• Investigators: Principal Investigator: Vincenzo Damico, Rn PhD, Department of Anesthesia and Critical Care, Asst Lecco

Study record dates

Study Major Dates

• Study Start (Actual): May 10, 2023
• Primary Completion (Estimated): April 30, 2024
• Study Completion (Estimated): May 30, 2024

Study Registration Dates

• First Submitted: April 12, 2023
• First Submitted That Met QC Criteria: April 24, 2023
• First Posted (Actual): May 6, 2023

Study Record Updates

• Last Update Posted (Actual): January 30, 2024
• Last Update Submitted That Met QC Criteria: January 29, 2024
• Last Verified: January 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pain; Neurologic Manifestations; Chronic Pain
• Other Study ID Numbers: Chronicare

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No