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: Completed
• Conditions: Pain
• Intervention / Treatment: Behavioral: Mindfulness-Based Stress Reduction

• Study Type: Interventional
• Enrollment (Actual): 49
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Canada
  • Ontario
    • Toronto, Ontario, Canada, M5G 1X5
      • Mount Sinai Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 80 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

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

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
No Intervention: Waitlist Control
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 Names: MBSR

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Pain disability and Attention	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	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	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	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	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	Change in acceptance assessed by the Chronic Pain Acceptance Questionnaire (CPAQ)	Baseline, immediately following treatment, and at 3 months follow up
Pain Intensity	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: York University
• Collaborators: Mount Sinai Hospital, Canada; Wasser Pain Management Centre; Rasch Foundation
• 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: December 1, 2011
• Primary Completion (Actual): November 1, 2013
• Study Completion (Actual): November 1, 2013

Study Registration Dates

• First Submitted: December 5, 2011
• First Submitted That Met QC Criteria: December 5, 2011
• First Posted (Estimate): December 7, 2011

Study Record Updates

• Last Update Posted (Estimate): February 13, 2014
• Last Update Submitted That Met QC Criteria: February 12, 2014
• Last Verified: February 1, 2014

More Information

Terms related to this study

• Keywords: Depression; Anxiety; Chronic Pain; Stress; Mindfulness; Attention; Meditation; Pain intensity; Acceptance; Pain disability
• Additional Relevant MeSH Terms: Pain; Neurologic Manifestations; Chronic Pain
• Other Study ID Numbers: FWA00003852