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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Control | No Intervention | Normal drug therapie or usual treatment | |
| Intervention | Experimental | Normal drug therapie or usual treatment with add Mindfulness-based stress reduction (MBSR) |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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 |
| 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 |
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Vincenzo Damico | Contact | +39 3409297118 | vi.damico@asst-lecco.it | |
| Vincenzo Damico | Contact | + 39 3409297118 | vi.damico@asst-lecco.it |
| Name | Affiliation | Role |
|---|---|---|
| Vincenzo Damico | Rn PhD, Department of Anesthesia and Critical Care, Asst Lecco | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| ASST Lecco | Recruiting | Lecco | 23814 | Italy |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 40082096 | Derived | 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. |
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| ID | Term |
|---|---|
| D059350 | Chronic Pain |
| ID | Term |
|---|---|
| D010146 | Pain |
| D009461 | Neurologic Manifestations |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
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| ID | Term |
|---|---|
| D000099024 | Mindfulness-Based Stress Reduction |
| ID | Term |
|---|---|
| D064866 | Mindfulness |
| D015928 | Cognitive Behavioral Therapy |
| D001521 | Behavior Therapy |
| D011613 | Psychotherapy |
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Randomized Controlled Trial (RCT)
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|
| 1 year |
| D004191 |
| Behavioral Disciplines and Activities |