PainNCT01487473
The Effects of Mindfulness-Based Stress Reduction on Attention and Pain-related Symptoms in Chronic Pain Patients
A study testing Mindfulness-Based Stress Reduction in people with Pain, run by York University at 1 site in Canada.
Trial summary
The main purpose of this study is to determine the degree to which Mindfulness-Based Stress Reduction, a group-based psychological therapy that includes mindfulness meditation exercises, reduces depression, anxiety, stress, pain intensity, and interference of pain with daily life among adult chronic pain patients. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Pain
- What is being tested?
- Mindfulness-Based Stress Reduction
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 49 participants
- Where
- 1 siteCanada
- Study dates
- Dec 2011to Nov 2013
- 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 18 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Adult chronic pain patients who are proficient in English
- Capable of interacting with others in a group setting
- Capable of working with a computer
Who cannot join
- Alcohol or drug abuse (past history is acceptable as long as their situation has been stable for at least 3 months)
- Psychiatric psychosis (patients who have a past history of schizophrenia are eligible as long as they are currently stable)
- Current major depressive disorder
- Current severe social phobia
- At immediate risk for suicide
- Cerebral lesions or tumors (unless medically and cognitively stable)
Show all 10Show fewer
- Neurological disease
- Medically unstable
- Cognitively unstable
- Previously participated in a mindfulness meditation program
Trial locations and contacts
1 site in 1 country.
About this study
Official title: The Effects of Mindfulness-Based Stress Reduction on Attention and Pain-related Symptoms in Chronic Pain Patients: A Randomized Controlled Trial
The main purpose of this study is to determine the degree to which Mindfulness-Based Stress Reduction, a group-based psychological therapy that includes mindfulness meditation exercises, reduces depression, anxiety, stress, pain intensity, and interference of pain with daily life among adult chronic pain patients.
The second purpose is to examine the role of attention in improving psychological and physical health for chronic pain patients.
- Conditions
- Pain
- Being tested
- Mindfulness-Based Stress Reduction
- Keywords
- Meditation, Mindfulness, Attention, Chronic Pain, Depression, Anxiety, Stress, Acceptance, Pain intensity, Pain disability
- Medical subject headings
- Pain, Chronic Pain, Depression, Anxiety Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Mindfulness-Based Stress ReductionBehavioural
Also called MBSR
An 8-week structured group program that was developed to improve psychological and physical symptoms associated with pain. It incorporates a variety of mindfulness meditation exercises including mindful yoga, sitting meditation, and body scan to facilitate attention, acceptance, and awareness of one's experiences.
| Study group | Role | What they receive |
|---|---|---|
| Mindfulness-Based Stress Reduction | Active comparator | Not described Receives: Behavioral: Mindfulness-Based Stress Reduction |
| Waitlist Control | No intervention | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
Pain disability and Attention
Change in pain disability assessed by the Pain Disability Index (PDI).
Change in attention assessed by an adapted version of the Change Blindness Task
Measured: Baseline, immediately following treatment, and at 3 months follow up
Secondary outcomes (6)
Depression
Change in depression assessed by the Depression, Anxiety, and Stress Scale 21 (DASS-21)
Measured: Baseline, immediately following treatment, and at 3 months follow up
Anxiety
Change in anxiety assessed by the Depression, Anxiety, and Stress Scale 21 (DASS-21)
Measured: Baseline, immediately following treatment, and at 3 months follow up
Stress
Change in stress assessed by the Depression, Anxiety, and Stress Scale 21 (DASS-21)
Measured: Baseline, immediately following treatment, and at 3 months follow up
Mindfulness
Change in mindfulness assessed by the Five Facet Mindfulness Questionnaire (FFMQ) and Mindful Attention Awareness Scale (MAAS)
Measured: Baseline, immediately following treatment, and at 3 months follow up
Acceptance
Change in acceptance assessed by the Chronic Pain Acceptance Questionnaire (CPAQ)
Measured: Baseline, immediately following treatment, and at 3 months follow up
Pain Intensity
Change in pain intensity assessed by the Short-form McGill Pain Questionnaire (SF-MPQ-2).
Measured: Baseline, immediately following treatment, and at 3 months follow up
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Dec 2011 (estimated)
- Study startDec 2011
- Primary completionNov 2013
- Study completionNov 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for 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
- Masking
- Single blind
- Who is masked
- Investigator
- Enrolment
- 49 participants (actual)
Sponsor and investigators
- Lead sponsor
- York University
- Sponsor type
- University, hospital or other
- Collaborators
- Mount Sinai Hospital, Canada, Wasser Pain Management Centre, Rasch Foundation
- Responsible party
- Principal investigator, Nicholas Cepeda, York University
- Investigators
- Nicholas Cepeda, PhD, Principal investigator, York UniversityAllan Gordon, MD, Principal investigator, MOUNT SINAI HOSPITALDenise Paneduro, PhD student, Study director, York University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01487473
- Sponsor's protocol ID
- FWA00003852
- Status last verified
- Feb 2014
- First submitted
- 5 Dec 2011
- Last updated
- 13 Feb 2014
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 13 Feb 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effects of Mindfulness-Based Stress Reduction on Attention and Pain-related Symptoms in Chronic Pain Patients: A Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT01487473
- Acronym / sponsor ID
- FWA00003852
- Conditions
- Pain
- Keywords
- Meditation, Mindfulness, Attention, Chronic Pain, Depression, Anxiety, Stress, Acceptance
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 49 participants (actual)
- Lead sponsor
- York UniversityUniversity, hospital or other
- Collaborators
- Mount Sinai Hospital, Canada, Wasser Pain Management Centre, Rasch Foundation
- Study start
- Dec 2011
- Primary completion
- Nov 2013 (actual)
- Study completion
- Nov 2013 (actual)
- First posted
- 7 Dec 2011 (estimated)
- 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.
The main purpose of this study is to determine the degree to which Mindfulness-Based Stress Reduction, a group-based psychological therapy that includes mindfulness meditation exercises, reduces depression, anxiety, stress, pain intensity, and interference of pain with daily life among adult chronic pain patients.
The second purpose is to examine the role of attention in improving psychological and physical health for chronic pain patients.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind (investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Mindfulness-Based Stress Reduction | Active comparator | Behavioral: Mindfulness-Based Stress Reduction |
| Waitlist Control | No intervention | – |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Adult chronic pain patients who are proficient in English
- Capable of interacting with others in a group setting
- Capable of working with a computer
Key exclusion criteria (10 listed)
- Alcohol or drug abuse (past history is acceptable as long as their situation has been stable for at least 3 months)
- Psychiatric psychosis (patients who have a past history of schizophrenia are eligible as long as they are currently stable)
- Current major depressive disorder
- Current severe social phobia
- At immediate risk for suicide
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 ReductionAlso: MBSRAn 8-week structured group program that was developed to improve psychological and physical symptoms associated with pain. It incorporates a variety of mindfulness meditation exercises including mindful yoga, sitting meditation, and body scan to facilitate attention, acceptance, and awareness of one's experiences. | Behavioural | Mindfulness-Based Stress Reduction |
Primary outcome
Pain disability and Attention
Time frame: Baseline, immediately following treatment, and at 3 months follow up
Change in pain disability assessed by the Pain Disability Index (PDI). Change in attention assessed by an adapted version of the Change Blindness Task
6 secondary outcomes
Depression
Time frame: Baseline, immediately following treatment, and at 3 months follow up
Anxiety
Time frame: Baseline, immediately following treatment, and at 3 months follow up
Stress
Time frame: Baseline, immediately following treatment, and at 3 months follow up
Mindfulness
Time frame: Baseline, immediately following treatment, and at 3 months follow up
Acceptance
Time frame: Baseline, immediately following treatment, and at 3 months follow up
Pain Intensity
Time frame: Baseline, immediately following treatment, and at 3 months follow up
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Feb 2014.
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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.
Nicholas Cepeda, PhD principal investigator
York University
Allan Gordon, MD principal investigator
MOUNT SINAI HOSPITAL
Denise Paneduro, PhD student study director
York University
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 in people with Pain, run by York University at 1 site in Canada.
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 3 inclusion and 10 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: finished, as of the sponsor's last update on 13 Feb 2014. 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 Canada. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Pain disability and Attention (time frame: Baseline, immediately following treatment, and at 3 months follow up). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 13 Feb 2014.