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

NCT05843409 | Unknown

• 1 other identifier: Chronicare
• Study Type: interventional
• Target: 200
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Chronic Pain

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (2)

• Quality of life assessore with EQ5D

  1 year

• Drug assumption

  1 year

Study Arms (2)

Control

NO INTERVENTION

Normal drug therapie or usual treatment

Intervention

EXPERIMENTAL

Normal drug therapie or usual treatment with add Mindfulness-based stress reduction (MBSR)

Behavioral: Mindfulness-based stress reduction (MBSR)

Interventions

Mindfulness-based stress reduction (MBSR) BEHAVIORAL

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

Intervention

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• Azienda Socio Sanitaria Territoriale di Lecco: lead

Study Sites (1)

ASST Lecco

Lecco, 23814, Italy

RECRUITING

Related Publications (1)

• Damico V, Milani M, Murano L. Effect of Mindfulness-Based Stress Reduction on Patients With Chronic Pain: A Randomized Controlled Trial. Pain Manag Nurs. 2025 Oct;26(5):510-522. doi: 10.1016/j.pmn.2025.02.010. Epub 2025 Mar 13.

  PMID: 40082096 DERIVED

MeSH Terms

Conditions

Chronic Pain

Interventions

Mindfulness-Based Stress Reduction

Condition Hierarchy (Ancestors)

Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

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

Study Officials

• Vincenzo Damico

  Rn PhD, Department of Anesthesia and Critical Care, Asst Lecco

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Vincenzo Damico

CONTACT

+39 3409297118; vi.damico@asst-lecco.it

Vincenzo Damico

CONTACT

+ 39 3409297118; vi.damico@asst-lecco.it

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator: Vincenzo Damico, Registered Nurse, Doctor of Philosophy, Department of Anesthesia and Critical Care, Azienda Socio Sanitaria Territoriale of Lecco

Model Details: Randomized Controlled Trial (RCT)

Study Record Dates

• First Submitted: April 12, 2023
• First Posted: May 6, 2023
• Study Start: May 10, 2023
• Primary Completion: April 30, 2024
• Study Completion: May 30, 2024
• Last Updated: January 30, 2024

Record last verified: 2024-01

Data Sharing

• IPD Sharing: Will not share

Locations

IT (1)