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Clinical Trials/NCT05843409
NCT05843409
Recruiting
Not Applicable

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

Azienda Socio Sanitaria Territoriale di Lecco1 site in 1 country200 target enrollmentMay 10, 2023
ConditionsChronic Pain

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Chronic Pain
Sponsor
Azienda Socio Sanitaria Territoriale di Lecco
Enrollment
200
Locations
1
Primary Endpoint
Chronic pain assessed with the Brief Pain Inventory (BPI)
Status
Recruiting
Last Updated
2 years ago

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.

Registry
clinicaltrials.gov
Start Date
May 10, 2023
End Date
May 30, 2024
Last Updated
2 years ago
Study Type
Interventional
Study Design
Crossover
Sex
All

Investigators

Sponsor
Azienda Socio Sanitaria Territoriale di Lecco
Responsible Party
Principal Investigator
Principal Investigator

Vincenzo Damico

Principal Investigator: Vincenzo Damico, Registered Nurse, Doctor of Philosophy, Department of Anesthesia and Critical Care, Azienda Socio Sanitaria Territoriale of Lecco

Azienda Socio Sanitaria Territoriale di Lecco

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

Outcomes

Primary Outcomes

Chronic pain assessed with the Brief Pain Inventory (BPI)

Time Frame: 1 year

Chronic or persistent pain is pain that carries on for longer than 12 weeks despite medication or treatment.

Secondary Outcomes

  • Drug assumption(1 year)
  • Quality of life assessore with EQ5D(1 year)

Study Sites (1)

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