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

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

Status
Recruiting
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT05843409
Acronym
Chronicare
Enrollment
200
Registered
2023-05-06
Start date
2023-05-10
Completion date
2024-05-30
Last updated
2024-01-30

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Chronic Pain

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.

Interventions

BEHAVIORALMindfulness-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

Sponsors

Azienda Socio Sanitaria Territoriale di Lecco
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
TREATMENT
Masking
NONE

Intervention model description

Randomized Controlled Trial (RCT)

Eligibility

Sex/Gender
ALL
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
Chronic pain assessed with the Brief Pain Inventory (BPI)1 yearChronic or persistent pain is pain that carries on for longer than 12 weeks despite medication or treatment.

Secondary

MeasureTime frameDescription
Quality of life assessore with EQ5D1 yearPerceived quality of life in the 5 dimension of EQ5D
Drug assumption1 yearDrug or therapy assumption by the patient for pain treatment

Countries

Italy

Contacts

Primary ContactVincenzo Damico
vi.damico@asst-lecco.it+39 3409297118
Backup ContactVincenzo Damico
vi.damico@asst-lecco.it+ 39 3409297118

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 5, 2026