The Effects of Mindfulness-Based Stress Reduction on Attention and Pain-related Symptoms in Chronic Pain Patients
Primary Purpose
Pain
Status
Completed
Phase
Not Applicable
Locations
Canada
Study Type
Interventional
Intervention
Mindfulness-Based Stress Reduction
Sponsored by
About this trial
This is an interventional treatment trial for Pain focused on measuring Meditation, Mindfulness, Attention, Chronic Pain, Depression, Anxiety, Stress, Acceptance, Pain intensity, Pain disability
Eligibility 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
Sites / Locations
- Mount Sinai Hospital
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
No Intervention
Arm Label
Mindfulness-Based Stress Reduction
Waitlist Control
Arm Description
Outcomes
Primary Outcome Measures
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
Secondary Outcome Measures
Depression
Change in depression assessed by the Depression, Anxiety, and Stress Scale 21 (DASS-21)
Anxiety
Change in anxiety assessed by the Depression, Anxiety, and Stress Scale 21 (DASS-21)
Stress
Change in stress assessed by the Depression, Anxiety, and Stress Scale 21 (DASS-21)
Mindfulness
Change in mindfulness assessed by the Five Facet Mindfulness Questionnaire (FFMQ) and Mindful Attention Awareness Scale (MAAS)
Acceptance
Change in acceptance assessed by the Chronic Pain Acceptance Questionnaire (CPAQ)
Pain Intensity
Change in pain intensity assessed by the Short-form McGill Pain Questionnaire (SF-MPQ-2).
Full Information
NCT ID
NCT01487473
First Posted
December 5, 2011
Last Updated
February 12, 2014
Sponsor
York University
Collaborators
Mount Sinai Hospital, Canada, Wasser Pain Management Centre, Rasch Foundation
1. Study Identification
Unique Protocol Identification Number
NCT01487473
Brief Title
The Effects of Mindfulness-Based Stress Reduction on Attention and Pain-related Symptoms in Chronic Pain Patients
Official Title
The Effects of Mindfulness-Based Stress Reduction on Attention and Pain-related Symptoms in Chronic Pain Patients: A Randomized Controlled Trial
Study Type
Interventional
2. Study Status
Record Verification Date
February 2014
Overall Recruitment Status
Completed
Study Start Date
December 2011 (undefined)
Primary Completion Date
November 2013 (Actual)
Study Completion Date
November 2013 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
York University
Collaborators
Mount Sinai Hospital, Canada, Wasser Pain Management Centre, Rasch Foundation
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief Summary
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Pain
Keywords
Meditation, Mindfulness, Attention, Chronic Pain, Depression, Anxiety, Stress, Acceptance, Pain intensity, Pain disability
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Crossover Assignment
Masking
Investigator
Allocation
Randomized
Enrollment
49 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Mindfulness-Based Stress Reduction
Arm Type
Active Comparator
Arm Title
Waitlist Control
Arm Type
No Intervention
Intervention Type
Behavioral
Intervention Name(s)
Mindfulness-Based Stress Reduction
Other Intervention Name(s)
MBSR
Intervention Description
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.
Primary Outcome Measure Information:
Title
Pain disability and Attention
Description
Change in pain disability assessed by the Pain Disability Index (PDI).
Change in attention assessed by an adapted version of the Change Blindness Task
Time Frame
Baseline, immediately following treatment, and at 3 months follow up
Secondary Outcome Measure Information:
Title
Depression
Description
Change in depression assessed by the Depression, Anxiety, and Stress Scale 21 (DASS-21)
Time Frame
Baseline, immediately following treatment, and at 3 months follow up
Title
Anxiety
Description
Change in anxiety assessed by the Depression, Anxiety, and Stress Scale 21 (DASS-21)
Time Frame
Baseline, immediately following treatment, and at 3 months follow up
Title
Stress
Description
Change in stress assessed by the Depression, Anxiety, and Stress Scale 21 (DASS-21)
Time Frame
Baseline, immediately following treatment, and at 3 months follow up
Title
Mindfulness
Description
Change in mindfulness assessed by the Five Facet Mindfulness Questionnaire (FFMQ) and Mindful Attention Awareness Scale (MAAS)
Time Frame
Baseline, immediately following treatment, and at 3 months follow up
Title
Acceptance
Description
Change in acceptance assessed by the Chronic Pain Acceptance Questionnaire (CPAQ)
Time Frame
Baseline, immediately following treatment, and at 3 months follow up
Title
Pain Intensity
Description
Change in pain intensity assessed by the Short-form McGill Pain Questionnaire (SF-MPQ-2).
Time Frame
Baseline, immediately following treatment, and at 3 months follow up
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Nicholas Cepeda, PhD
Organizational Affiliation
York University
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Allan Gordon, MD
Organizational Affiliation
MOUNT SINAI HOSPITAL
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Denise Paneduro, PhD student
Organizational Affiliation
York University
Official's Role
Study Director
Facility Information:
Facility Name
Mount Sinai Hospital
City
Toronto
State/Province
Ontario
ZIP/Postal Code
M5G 1X5
Country
Canada
12. IPD Sharing Statement
Learn more about this trial
The Effects of Mindfulness-Based Stress Reduction on Attention and Pain-related Symptoms in Chronic Pain Patients
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