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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

NA

Total Enrollment

200 participants

Study Classification

INTERVENTIONAL

Study Start Date

2023-05-10

Study Completion Date

2024-05-30

Brief Summary

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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.

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Detailed Description

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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.

Conditions

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Chronic Pain

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Randomized Controlled Trial (RCT)

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Control

Normal drug therapie or usual treatment

Group Type NO_INTERVENTION

No interventions assigned to this group

Intervention

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

Group Type EXPERIMENTAL

Mindfulness-based stress reduction (MBSR)

Intervention Type 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

Interventions

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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

Intervention Type BEHAVIORAL

Eligibility Criteria

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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

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Responsible Party

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Vincenzo Damico

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

Responsibility Role PRINCIPAL_INVESTIGATOR