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

Chronic Pain Clinical Trial

— Chronicare  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05843409
• Other study ID #: Chronicare
• Status: Recruiting
• Phase: N/A
• Start date: May 10, 2023
• Est. completion date: May 30, 2024

Study information

• Verified date: January 2024
• Source: Azienda Socio Sanitaria Territoriale di Lecco
• Contact: Vincenzo Damico
• Phone: +39 3409297118
• Email: vi.damico[@]asst-lecco.it
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 200
• Est. completion date: May 30, 2024
• Est. primary completion date: April 30, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A and older

Eligibility

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

Related Conditions & MeSH terms

• Chronic Pain

Intervention

Behavioral:
• Mindfulness-based stress reduction (MBSR)
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

Locations

Country	Name	City	State
Italy	ASST Lecco	Lecco

Sponsors (1)

Lead Sponsor	Collaborator
Azienda Socio Sanitaria Territoriale di Lecco

Country where clinical trial is conducted

Italy, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Quality of life assessore with EQ5D	Perceived quality of life in the 5 dimension of EQ5D	1 year
Secondary	Drug assumption	Drug or therapy assumption by the patient for pain treatment	1 year