The Effects of Mindfulness-Based Stress Reduction on Attention and Pain-related Symptoms in Chronic Pain Patients
This study is currently recruiting participants.
Verified December 2011 by York University
Sponsor:
York University
Collaborators:
Mount Sinai Hospital, Canada
Wasser Pain Management Centre
Rasch Foundation
Information provided by (Responsible Party):
Nicholas Cepeda, York University
ClinicalTrials.gov Identifier:
NCT01487473
First received: December 5, 2011
Last updated: December 28, 2011
Last verified: December 2011
- Full Text View
- Tabular View
- No Study Results Posted
- Disclaimer
- How to Read a Study Record
Purpose
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.
| Condition | Intervention |
|---|---|
|
Pain |
Behavioral: Mindfulness-Based Stress Reduction |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Efficacy Study Intervention Model: Crossover Assignment Masking: Single Blind (Investigator) Primary Purpose: Treatment |
| Official Title: | The Effects of Mindfulness-Based Stress Reduction on Attention and Pain-related Symptoms in Chronic Pain Patients: A Randomized Controlled Trial |
Resource links provided by NLM:
Further study details as provided by York University:
Primary Outcome Measures:
- Pain disability and Attention [ Time Frame: Baseline, immediately following treatment, and at 3 months follow up ] [ Designated as safety issue: No ]
Change in pain disability assessed by the Pain Disability Index (PDI).
Change in attention assessed by an adapted version of the Change Blindness Task
Secondary Outcome Measures:
- Depression [ Time Frame: Baseline, immediately following treatment, and at 3 months follow up ] [ Designated as safety issue: No ]Change in depression assessed by the Depression, Anxiety, and Stress Scale 21 (DASS-21)
- Anxiety [ Time Frame: Baseline, immediately following treatment, and at 3 months follow up ] [ Designated as safety issue: No ]Change in anxiety assessed by the Depression, Anxiety, and Stress Scale 21 (DASS-21)
- Stress [ Time Frame: Baseline, immediately following treatment, and at 3 months follow up ] [ Designated as safety issue: No ]Change in stress assessed by the Depression, Anxiety, and Stress Scale 21 (DASS-21)
- Mindfulness [ Time Frame: Baseline, immediately following treatment, and at 3 months follow up ] [ Designated as safety issue: No ]Change in mindfulness assessed by the Five Facet Mindfulness Questionnaire (FFMQ) and Mindful Attention Awareness Scale (MAAS)
- Acceptance [ Time Frame: Baseline, immediately following treatment, and at 3 months follow up ] [ Designated as safety issue: No ]Change in acceptance assessed by the Chronic Pain Acceptance Questionnaire (CPAQ)
- Pain Intensity [ Time Frame: Baseline, immediately following treatment, and at 3 months follow up ] [ Designated as safety issue: No ]Change in pain intensity assessed by the Short-form McGill Pain Questionnaire (SF-MPQ-2).
| Estimated Enrollment: | 60 |
| Study Start Date: | December 2011 |
| Estimated Study Completion Date: | October 2013 |
| Estimated Primary Completion Date: | October 2013 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
| Active Comparator: Mindfulness-Based Stress Reduction |
Behavioral: 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 Name: MBSR
|
| No Intervention: Waitlist Control |
Eligibility| Ages Eligible for Study: | 18 Years to 80 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Criteria
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
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01487473
Contacts
| Contact: Marilyn Galonski | 416-586-4800 ext 2384 | mgalonski@mtsinai.on.ca |
| Contact: Leah Pink | 416-650-2714 ext 2979 | lpink@mtsinai.on.ca |
Locations
| Canada, Ontario | |
| Mount Sinai Hospital | Recruiting |
| Toronto, Ontario, Canada, M5G 1X5 | |
| Contact: Allan Gordon, MD 416-586-5181 agordon@mtsinai.on.ca | |
| Contact: Marilyn Galonski 416-586-4800 ext 2384 mgalonski@mtsinai.on.ca | |
| Principal Investigator: Allan Gordon, MD | |
Sponsors and Collaborators
York University
Mount Sinai Hospital, Canada
Wasser Pain Management Centre
Rasch Foundation
Investigators
| Principal Investigator: | Nicholas Cepeda, PhD | York University |
| Principal Investigator: | Allan Gordon, MD | Mt. Sinai Hospital |
| Study Director: | Denise Paneduro, PhD student | York University |
More Information
No publications provided
| Responsible Party: | Nicholas Cepeda, Associate Professor, York University |
| ClinicalTrials.gov Identifier: | NCT01487473 History of Changes |
| Other Study ID Numbers: | FWA00003852 |
| Study First Received: | December 5, 2011 |
| Last Updated: | December 28, 2011 |
| Health Authority: | Canada: Ethics Review Committee |
Keywords provided by York University:
|
Meditation Mindfulness Attention Chronic Pain Depression |
Anxiety Stress Acceptance Pain intensity Pain disability |
ClinicalTrials.gov processed this record on May 19, 2013