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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:
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: February 12, 2014
Last verified: February 2014
  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).


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

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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: 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

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: February 12, 2014
Health Authority: Canada: Ethics Review Committee

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

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

ClinicalTrials.gov processed this record on November 25, 2014