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The Effects of Mindfulness-Based Stress Reduction on Attention and Pain-related Symptoms in Chronic Pain Patients

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01487473
First Posted: December 7, 2011
Last Update Posted: February 13, 2014
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Collaborators:
Mount Sinai Hospital, Canada
Wasser Pain Management Centre
Rasch Foundation
Information provided by (Responsible Party):
Nicholas Cepeda, York University
  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
Intervention Model: Crossover Assignment
Masking: Single (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 Nicholas Cepeda, York University:

Primary Outcome Measures:
  • 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



Secondary Outcome Measures:
  • 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)

  • 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)

  • 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)

  • 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)

  • Acceptance [ Time Frame: Baseline, immediately following treatment, and at 3 months follow up ]
    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 ]
    Change in pain intensity assessed by the Short-form McGill Pain Questionnaire (SF-MPQ-2).


Enrollment: 49
Study Start Date: December 2011
Study Completion Date: November 2013
Primary Completion Date: November 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

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 80 Years   (Adult, Senior)
Sexes Eligible for Study:   All
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
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01487473


Locations
Canada, Ontario
Mount Sinai Hospital
Toronto, Ontario, Canada, M5G 1X5
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, Chicago
Study Director: Denise Paneduro, PhD student York University
  More Information

Responsible Party: Nicholas Cepeda, Associate Professor, York University
ClinicalTrials.gov Identifier: NCT01487473     History of Changes
Other Study ID Numbers: FWA00003852
First Submitted: December 5, 2011
First Posted: December 7, 2011
Last Update Posted: February 13, 2014
Last Verified: February 2014

Keywords provided by Nicholas Cepeda, York University:
Meditation
Mindfulness
Attention
Chronic Pain
Depression
Anxiety
Stress
Acceptance
Pain intensity
Pain disability

Additional relevant MeSH terms:
Chronic Pain
Pain
Neurologic Manifestations
Nervous System Diseases
Signs and Symptoms