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

Azienda Socio Sanitaria Territoriale di Lecco

Status: Enrolling

Conditions: Chronic Pain

Treatments: Behavioral: Mindfulness-based stress reduction (MBSR)

Study type: Interventional

Funder types: Other

Identifiers

NCT05843409

Chronicare

Details and patient eligibility

About

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.

Full 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.

Enrollment: 200 estimated patients

Sex: All

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: None (Open label)

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200 participants in 2 patient groups

Control

No Intervention group

Description:

Normal drug therapie or usual treatment

Intervention

Experimental group

Description:

Normal drug therapie or usual treatment with add Mindfulness-based stress reduction (MBSR)

Treatment:

Behavioral: Mindfulness-based stress reduction (MBSR)