NCT01487473

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
49

participants targeted

Target at P25-P50 for not_applicable pain

Timeline
Completed

Started Dec 2011

Typical duration for not_applicable pain

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

December 1, 2011

Completed
4 days until next milestone

First Submitted

Initial submission to the registry

December 5, 2011

Completed
2 days until next milestone

First Posted

Study publicly available on registry

December 7, 2011

Completed
1.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 1, 2013

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

November 1, 2013

Completed
Last Updated

February 13, 2014

Status Verified

February 1, 2014

Enrollment Period

1.9 years

First QC Date

December 5, 2011

Last Update Submit

February 12, 2014

Conditions

Pain

Keywords

MeditationMindfulnessAttentionChronic PainDepressionAnxietyStressAcceptancePain intensityPain disability

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (6)

  • Depression

    Baseline, immediately following treatment, and at 3 months follow up

  • Anxiety

    Baseline, immediately following treatment, and at 3 months follow up

  • Stress

    Baseline, immediately following treatment, and at 3 months follow up

  • Mindfulness

    Baseline, immediately following treatment, and at 3 months follow up

  • Acceptance

    Baseline, immediately following treatment, and at 3 months follow up

  • +1 more secondary outcomes

Study Arms (2)

Mindfulness-Based Stress Reduction

ACTIVE COMPARATOR
Behavioral: Mindfulness-Based Stress Reduction

Waitlist Control

NO INTERVENTION

Interventions

Mindfulness-Based Stress ReductionBEHAVIORAL

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.

Also known as: MBSR
Mindfulness-Based Stress Reduction

Eligibility Criteria

Age18 Years - 80 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Adult chronic pain patients who are proficient in English
  • Capable of interacting with others in a group setting
  • Capable of working with a computer

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Mount Sinai Hospital

Toronto, Ontario, M5G 1X5, Canada

Location

MeSH Terms

Conditions

PainChronic PainDepressionAnxiety Disorders

Interventions

Mindfulness-Based Stress Reduction

Condition Hierarchy (Ancestors)

Neurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and SymptomsBehavioral SymptomsBehaviorMental Disorders

Intervention Hierarchy (Ancestors)

MindfulnessCognitive Behavioral TherapyBehavior TherapyPsychotherapyBehavioral Disciplines and Activities

Study Officials

  • Nicholas Cepeda, PhD

    York University

    PRINCIPAL INVESTIGATOR

  • Allan Gordon, MD

    MOUNT SINAI HOSPITAL

    PRINCIPAL INVESTIGATOR

  • Denise Paneduro, PhD student

    York University

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
INVESTIGATOR
Purpose
TREATMENT
Intervention Model
CROSSOVER
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Associate Professor

Study Record Dates

First Submitted

December 5, 2011

First Posted

December 7, 2011

Study Start

December 1, 2011

Primary Completion

November 1, 2013

Study Completion

November 1, 2013

Last Updated

February 13, 2014

Record last verified: 2014-02

Locations

CA(1)