Chronic PainChronicareNCT05843409
Mindfulness-based Stress Reduction (MBSR) for Reduction of Chronic Pain and Drug Therapie
A study testing Mindfulness-based stress reduction (MBSR) in people with Chronic Pain, run by Azienda Socio Sanitaria Territoriale di Lecco at 1 site in Italy.
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. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Chronic Pain
- What is being tested?
- Mindfulness-based stress reduction (MBSR)
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 200 participants
- Where
- 1 siteItaly
- Study dates
- 10 May 2023to 30 May 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Patients being treated for Chronic Pain
- Patients with Chronic Pain in Pharmacological Therapy
Who cannot join
- Patients with Chronic Pain not in Pharmacological Therapy
- Patients without Chronic Pain
Trial locations and contacts
1 site in 1 country.
Italy1 site, 1 recruiting
- Recruiting
ASST Lecco
Lecco, 23814
VINCENZO LC DAMICO, 3409297118 ext. LC, vi.damico@asst-lecco.it
About this study
Official title: Mindfulness-based Stress Reduction or Usual Treatment for Treatment of Chronic Pain in an Italian Hospital
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.
Read the 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.
- Conditions
- Chronic Pain
- Being tested
- Mindfulness-based stress reduction (MBSR)
- Medical subject headings
- Chronic Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Mindfulness-based stress reduction (MBSR)Behavioural
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
| Study group | Role | What they receive |
|---|---|---|
| Control | No intervention | Normal drug therapie or usual treatment |
| Intervention | Experimental | Normal drug therapie or usual treatment with add Mindfulness-based stress reduction (MBSR) Receives: Behavioral: Mindfulness-based stress reduction (MBSR) |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 1 year
Secondary outcomes (2)
Quality of life assessore with EQ5D
Perceived quality of life in the 5 dimension of EQ5D
Measured: 1 year
Drug assumption
Drug or therapy assumption by the patient for pain treatment
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 May 2023
- Study start10 May 2023
- Primary completion30 Apr 2024 (estimated)
- Study completion30 May 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Chronic PainStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Model description
- Randomized Controlled Trial (RCT)
- Masking
- None (open label)
- Enrolment
- 200 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Azienda Socio Sanitaria Territoriale di Lecco
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Vincenzo Damico, Azienda Socio Sanitaria Territoriale di Lecco
- Investigators
- Vincenzo Damico, Principal investigator, Rn PhD, Department of Anesthesia and Critical Care, Asst Lecco
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05843409
- Sponsor's protocol ID
- Chronicare
- Acronym
- Chronicare
- Status last verified
- Jan 2024
- First submitted
- 12 Apr 2023
- Last updated
- 30 Jan 2024
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Damico V, Milani M, Murano L. Effect of Mindfulness-Based Stress Reduction on Patients With Chronic Pain: A Randomized Controlled Trial. Pain Manag Nurs. 2025 Oct;26(5):510-522. doi: 10.1016/j.pmn.2025.02.010. Epub 2025 Mar 13.
PubMed 40082096
Study at a glance
From the registry record, last updated by the sponsor on 30 Jan 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Mindfulness-based Stress Reduction or Usual Treatment for Treatment of Chronic Pain in an Italian Hospital
- ClinicalTrials.gov ID
- NCT05843409
- Acronym / sponsor ID
- Chronicare / Chronicare
- Conditions
- Chronic Pain
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 200 participants (estimated)
- Lead sponsor
- Azienda Socio Sanitaria Territoriale di LeccoUniversity, hospital or other
- Study start
- 10 May 2023 (actual)
- Primary completion
- 30 Apr 2024 (estimated)
- Study completion
- 30 May 2024 (estimated)
- First posted
- 6 May 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Randomized Controlled Trial (RCT)
| Arm | Type | Receives |
|---|---|---|
| Control | No intervention | –Normal drug therapie or usual treatment |
| Intervention | Experimental | Behavioral: Mindfulness-based stress reduction (MBSR)Normal drug therapie or usual treatment with add Mindfulness-based stress reduction (MBSR) |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (2 listed)
- Patients being treated for Chronic Pain
- Patients with Chronic Pain in Pharmacological Therapy
Key exclusion criteria (2 listed)
- Patients with Chronic Pain not in Pharmacological Therapy
- Patients without Chronic Pain
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 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 | Behavioural | Intervention |
Primary outcome
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.
2 secondary outcomes
Quality of life assessore with EQ5D
Time frame: 1 year
Drug assumption
Time frame: 1 year
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Jan 2024.
- Derived from this study: PubMed 40082096Damico V, Milani M, Murano L. Effect of Mindfulness-Based Stress Reduction on Patients With Chronic Pain: A Randomized Controlled Trial. Pain Manag Nurs. 2025 Oct;26(5):510-522. doi: 10.1016/j.pmn.2025.02.010. Epub 2025 Mar 13.
- Individual participant dataSharing planned: No
Related trials for Chronic Pain
Recruiting
Empowered Relief® for Cancer Survivors With Chronic Pain
Chronic Pain Due to Cancer, Pain Catastrophizing
RecruitingObservational study
Pain Phenotypes in Individuals With Multiple Sclerosis
Multiple Sclerosis, Chronic Pain
Not yet recruiting
Effect of Lumbar Stabilization Exercises With and Without YTWL (Scapular Stabilization Exercises) on Reducing Chronic Low Back Pain and Related Disability. A Randomized Clinical Trial,
Chronic Non Specific Mechanical Low Back Pain
Not yet recruiting
Comparing Non-Medicine Strategies for Improving Low Back Pain
Chronic Low-back Pain (cLBP), High-Impact Chronic Pain (HICP)
Not yet recruiting
Effect of Pectoral Nerve Block (PECS) Using Magnesium Sulfate Added to Dexamethasone on Quality of Recovery and Chronic Post-Mastectomy Pain
Breast Cancer, Postoperative Pain
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Vincenzo Damico principal investigator
Rn PhD, Department of Anesthesia and Critical Care, Asst Lecco
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Mindfulness-based stress reduction (MBSR) in people with Chronic Pain, run by Azienda Socio Sanitaria Territoriale di Lecco at 1 site in Italy.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 30 Jan 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Italy. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Vincenzo Damico (+39 3409297118, vi.damico@asst-lecco.it), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Chronic pain assessed with the Brief Pain Inventory (BPI) (time frame: 1 year). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05843409, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 30 Jan 2024.