Mindfulness-based Stress Reduction (MBSR) for Reduction of Chronic Pain and Drug Therapie (Chronicare)
Primary Purpose
Chronic Pain
Status
Recruiting
Phase
Not Applicable
Locations
Italy
Study Type
Interventional
Intervention
Mindfulness-based stress reduction (MBSR)
Sponsored by
About this trial
This is an interventional treatment trial for Chronic Pain
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
Sites / Locations
- ASST LeccoRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
No Intervention
Experimental
Arm Label
Control
Intervention
Arm Description
Normal drug therapie or usual treatment
Normal drug therapie or usual treatment with add Mindfulness-based stress reduction (MBSR)
Outcomes
Primary Outcome Measures
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.
Secondary Outcome Measures
Quality of life assessore with EQ5D
Perceived quality of life in the 5 dimension of EQ5D
Drug assumption
Drug or therapy assumption by the patient for pain treatment
Full Information
NCT ID
NCT05843409
First Posted
April 12, 2023
Last Updated
June 27, 2023
Sponsor
Azienda Socio Sanitaria Territoriale di Lecco
1. Study Identification
Unique Protocol Identification Number
NCT05843409
Brief Title
Mindfulness-based Stress Reduction (MBSR) for Reduction of Chronic Pain and Drug Therapie
Acronym
Chronicare
Official Title
Mindfulness-based Stress Reduction or Usual Treatment for Treatment of Chronic Pain in an Italian Hospital
Study Type
Interventional
2. Study Status
Record Verification Date
June 2023
Overall Recruitment Status
Recruiting
Study Start Date
May 10, 2023 (Actual)
Primary Completion Date
September 30, 2023 (Anticipated)
Study Completion Date
November 30, 2023 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Azienda Socio Sanitaria Territoriale di Lecco
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Chronic Pain
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Crossover Assignment
Model Description
Randomized Controlled Trial (RCT)
Masking
None (Open Label)
Allocation
Randomized
Enrollment
200 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Control
Arm Type
No Intervention
Arm Description
Normal drug therapie or usual treatment
Arm Title
Intervention
Arm Type
Experimental
Arm Description
Normal drug therapie or usual treatment with add Mindfulness-based stress reduction (MBSR)
Intervention Type
Behavioral
Intervention Name(s)
Mindfulness-based stress reduction (MBSR)
Intervention Description
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
Primary Outcome Measure Information:
Title
Chronic pain assessed with the Brief Pain Inventory (BPI)
Description
Chronic or persistent pain is pain that carries on for longer than 12 weeks despite medication or treatment.
Time Frame
1 year
Secondary Outcome Measure Information:
Title
Quality of life assessore with EQ5D
Description
Perceived quality of life in the 5 dimension of EQ5D
Time Frame
1 year
Title
Drug assumption
Description
Drug or therapy assumption by the patient for pain treatment
Time Frame
1 year
10. Eligibility
Sex
All
Accepts Healthy Volunteers
No
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Vincenzo Damico
Phone
+39 3409297118
Email
vi.damico@asst-lecco.it
First Name & Middle Initial & Last Name or Official Title & Degree
Vincenzo Damico
Phone
+ 39 3409297118
Email
vi.damico@asst-lecco.it
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Vincenzo Damico
Organizational Affiliation
Rn PhD, Department of Anesthesia and Critical Care, Asst Lecco
Official's Role
Principal Investigator
Facility Information:
Facility Name
ASST Lecco
City
Lecco
ZIP/Postal Code
23814
Country
Italy
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
VINCENZO LC DAMICO
Phone
3409297118
Ext
LC
Email
vi.damico@asst-lecco.it
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
Mindfulness-based Stress Reduction (MBSR) for Reduction of Chronic Pain and Drug Therapie
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