Clinical trial NCT01487473: 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
Overall status: COMPLETED
Phase: NA
Conditions: Pain
Keywords: Meditation
Mindfulness
Attention
Chronic Pain
Depression
Anxiety
Stress
Acceptance
Pain intensity
Pain disability
Lead sponsor: York University
Sponsor class: OTHER
Collaborators: name: Mount Sinai Hospital, Canada
name: Wasser Pain Management Centre
name: Rasch Foundation
First posted: 2011-12-07
Enrollment: 49
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

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.


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

Primary outcomes:
measure: Pain disability and Attention
timeFrame: Baseline, immediately following treatment, and at 3 months follow up
Secondary outcomes:
measure: Depression
timeFrame: Baseline, immediately following treatment, and at 3 months follow up
measure: Anxiety
timeFrame: Baseline, immediately following treatment, and at 3 months follow up
measure: Stress
timeFrame: Baseline, immediately following treatment, and at 3 months follow up
measure: Mindfulness
timeFrame: Baseline, immediately following treatment, and at 3 months follow up
measure: Acceptance
timeFrame: Baseline, immediately following treatment, and at 3 months follow up
measure: Pain Intensity
timeFrame: Baseline, immediately following treatment, and at 3 months follow up
Other outcomes:
Locations:
city: Toronto
country: Canada
facility: Mount Sinai Hospital
state: Ontario
Study officials:
affiliation: York University
name: Nicholas Cepeda, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: MOUNT SINAI HOSPITAL
name: Allan Gordon, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: York University
name: Denise Paneduro, PhD student
role: STUDY_DIRECTOR
References: