- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01487473
The Effects of Mindfulness-Based Stress Reduction on Attention and Pain-related Symptoms in Chronic Pain Patients
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.
Study Overview
Status
Conditions
Intervention / Treatment
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
Ontario
-
Toronto, Ontario, Canada, M5G 1X5
- Mount Sinai Hospital
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- Adult chronic pain patients who are proficient in English
- Capable of interacting with others in a group setting
- Capable of working with a computer
Exclusion Criteria:
- 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)
- Neurological disease
- Medically unstable
- Cognitively unstable
- Previously participated in a mindfulness meditation program
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Crossover Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
No Intervention: Waitlist Control
|
|
Active Comparator: Mindfulness-Based Stress Reduction
|
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.
Other Names:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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 |
Baseline, immediately following treatment, and at 3 months follow up
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Depression
Time Frame: Baseline, immediately following treatment, and at 3 months follow up
|
Change in depression assessed by the Depression, Anxiety, and Stress Scale 21 (DASS-21)
|
Baseline, immediately following treatment, and at 3 months follow up
|
Anxiety
Time Frame: Baseline, immediately following treatment, and at 3 months follow up
|
Change in anxiety assessed by the Depression, Anxiety, and Stress Scale 21 (DASS-21)
|
Baseline, immediately following treatment, and at 3 months follow up
|
Stress
Time Frame: Baseline, immediately following treatment, and at 3 months follow up
|
Change in stress assessed by the Depression, Anxiety, and Stress Scale 21 (DASS-21)
|
Baseline, immediately following treatment, and at 3 months follow up
|
Mindfulness
Time Frame: Baseline, immediately following treatment, and at 3 months follow up
|
Change in mindfulness assessed by the Five Facet Mindfulness Questionnaire (FFMQ) and Mindful Attention Awareness Scale (MAAS)
|
Baseline, immediately following treatment, and at 3 months follow up
|
Acceptance
Time Frame: Baseline, immediately following treatment, and at 3 months follow up
|
Change in acceptance assessed by the Chronic Pain Acceptance Questionnaire (CPAQ)
|
Baseline, immediately following treatment, and at 3 months follow up
|
Pain Intensity
Time Frame: Baseline, immediately following treatment, and at 3 months follow up
|
Change in pain intensity assessed by the Short-form McGill Pain Questionnaire (SF-MPQ-2).
|
Baseline, immediately following treatment, and at 3 months follow up
|
Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Allan Gordon, MD, Mount Sinai Hospital
- Principal Investigator: Nicholas Cepeda, PhD, York University
- Study Director: Denise Paneduro, PhD student, York University
Study record dates
Study Major Dates
Study Start
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- FWA00003852
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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