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

Pain Clinical Trial

Official title:

The Effects of Mindfulness-Based Stress Reduction on Attention and Pain-related Symptoms in Chronic Pain Patients: A Randomized Controlled Trial

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01487473
• Other study ID #: FWA00003852
• Status: Completed
• Phase: N/A
• First received: December 5, 2011
• Last updated: February 12, 2014
• Start date: December 2011
• Est. completion date: November 2013

Study information

• Verified date: February 2014
• Source: York University
• Contact: n/a
• Is FDA regulated: No
• Health authority: Canada: Ethics Review Committee
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 49
• Est. completion date: November 2013
• Est. primary completion date: November 2013
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 80 Years

Eligibility

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 Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Crossover Assignment, Masking: Single Blind (Investigator), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Chronic Pain
• Pain

Intervention

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.

Locations

Country	Name	City	State
Canada	Mount Sinai Hospital	Toronto	Ontario

Sponsors (4)

Lead Sponsor	Collaborator
York University	Mount Sinai Hospital, Canada, Rasch Foundation, Wasser Pain Management Centre

Country where clinical trial is conducted

Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No
Secondary	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	No
Secondary	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	No
Secondary	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	No
Secondary	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	No
Secondary	Acceptance	Change in acceptance assessed by the Chronic Pain Acceptance Questionnaire (CPAQ)	Baseline, immediately following treatment, and at 3 months follow up	No
Secondary	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	No