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

Study Overview
=================
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.

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

Conditions
-----------------
Chronic Pain

Intervention / Treatment
-----------------
* Behavioral: Mindfulness-based stress reduction (MBSR)


Participation Criteria
=================
Eligibility Criteria
-----------------
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
Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Crossover Assignment
Interventional Model Description: Randomized Controlled Trial (RCT)
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| No Intervention: Control<br>Normal drug therapie or usual treatment | |
| Experimental: Intervention<br>Normal drug therapie or usual treatment with add Mindfulness-based stress reduction (MBSR) | Behavioral: Mindfulness-based stress reduction (MBSR)<br>* 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<br>|

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 |