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

Not Applicable

Recruiting

• Conditions: Chronic Pain
• Interventions: Behavioral: Mindfulness-based stress reduction (MBSR)

• Registration Number: NCT05843409
• Lead Sponsor: Azienda Socio Sanitaria Territoriale di Lecco

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.

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 Timeline

• Study First Submitted: 2023-04-12
• Study First Submitted QC: 2023-04-24
• Study First Posted: 2023-05-06
• Study Start: 2023-05-10
• Status Verified: 2024-01
• Last Update Submitted: 2024-01-29
• Last Update Posted: 2024-01-30
• Primary Completion: 2024-04-30
• Study Completion: 2024-05-30

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 200

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

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

Primary Outcome Measures

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

Secondary Outcome Measures

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

Trial Locations

Locations (1)

ASST Lecco; 🇮🇹 Lecco, Italy