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Completed

NCT Number: NCT01487473

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

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.

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Key information

Conditions

Pain Anxiety Disorders Behavior Behavioral Symptoms Chronic Pain Depression Mental Disorders Neurologic Manifestations Pathological Conditions, Signs and Symptoms Signs and Symptoms

Age range

18 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Mount Sinai Hospital

Toronto, Ontario, M5G 1X5, Canada

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Mindfulness-Based Stress Reduction

Behavioral

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

Primary outcomes

  1. Pain disability and Attention

    Time frame: Baseline, immediately following treatment, and at 3 months follow up

    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 outcomes

  1. Depression

    Time frame: Baseline, immediately following treatment, and at 3 months follow up

    Change in depression assessed by the Depression, Anxiety, and Stress Scale 21 (DASS-21)

  2. Anxiety

    Time frame: Baseline, immediately following treatment, and at 3 months follow up

    Change in anxiety assessed by the Depression, Anxiety, and Stress Scale 21 (DASS-21)

  3. Stress

    Time frame: Baseline, immediately following treatment, and at 3 months follow up

    Change in stress assessed by the Depression, Anxiety, and Stress Scale 21 (DASS-21)

  4. Mindfulness

    Time frame: Baseline, immediately following treatment, and at 3 months follow up

    Change in mindfulness assessed by the Five Facet Mindfulness Questionnaire (FFMQ) and Mindful Attention Awareness Scale (MAAS)

  5. Acceptance

    Time frame: Baseline, immediately following treatment, and at 3 months follow up

    Change in acceptance assessed by the Chronic Pain Acceptance Questionnaire (CPAQ)

  6. Pain Intensity

    Time frame: Baseline, immediately following treatment, and at 3 months follow up

    Change in pain intensity assessed by the Short-form McGill Pain Questionnaire (SF-MPQ-2).

Sponsors and collaborators

Lead sponsor

York University

Other

Collaborators

  • Mount Sinai Hospital, Canada
  • Rasch Foundation
  • Wasser Pain Management Centre

Registry information

Official study title

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

Important dates

Study start
2011
Primary completion
2013
Study completion
2013
First posted
Dec 7, 2011
Registry last updated
Feb 13, 2014

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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