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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:
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
History of Changes

December 5, 2011
December 28, 2011
December 2011
October 2013   (final data collection date for primary outcome measure)
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
Same as current
Complete list of historical versions of study NCT01487473 on ClinicalTrials.gov Archive Site
  • 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).
Same as current
Not Provided
Not Provided
 
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.
Not Provided
Interventional
Not Provided
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Crossover Assignment
Masking: Single Blind (Investigator)
Primary Purpose: Treatment
Pain
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
  • Active Comparator: Mindfulness-Based Stress Reduction
    Intervention: Behavioral: Mindfulness-Based Stress Reduction
  • No Intervention: Waitlist Control
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
60
October 2013
October 2013   (final data collection date for primary outcome measure)

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
Both
18 Years to 80 Years
No
Contact: Marilyn Galonski 416-586-4800 ext 2384 mgalonski@mtsinai.on.ca
Contact: Leah Pink 416-650-2714 ext 2979 lpink@mtsinai.on.ca
Canada
 
NCT01487473
FWA00003852
No
Nicholas Cepeda, York University
York University
  • Mount Sinai Hospital, Canada
  • Wasser Pain Management Centre
  • Rasch Foundation
Principal Investigator: Nicholas Cepeda, PhD York University
Principal Investigator: Allan Gordon, MD Mt. Sinai Hospital
Study Director: Denise Paneduro, PhD student York University
York University
December 2011

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP