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Comparison of the Efficacy and Mechanisms for MBCT and CT for Multiple Sclerosis (MS) Chronic Pain

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ClinicalTrials.gov Identifier: NCT02012439
Recruitment Status : Completed
First Posted : December 16, 2013
Last Update Posted : September 16, 2019
Sponsor:
Collaborator:
National Multiple Sclerosis Society
Information provided by (Responsible Party):
Dawn Ehde, University of Washington

Brief Summary:
Chronic pain is a pervasive, serious problem for many individuals with multiple sclerosis (MS) that is typically inadequately treated by medications alone. There is a critical need to develop and evaluate innovative psychosocial interventions that have the capacity to effectively target the multidimensional nature of MS pain. Cognitive Therapy (CT) is one psychosocial treatment that has been found to be a potentially beneficial treatment for chronic MS pain. This approach teaches patients to identify and replace unhelpful thoughts about pain with helpful, more adaptive thoughts. In addition, over the past decade there has been a steady upsurge of research examining mindfulness meditation-based therapies for the treatment of medical conditions, including symptoms associated with MS. Mindfulness mediation involves training the mind to disengage from automatic thinking patterns to mindfully perceive, in a non-judgmental manner, one's moment-to-moment experiences. This meditation technique teaches patients to become aware of thoughts, emotions, and physical sensations and to recognize that these are transient experiences that can be mindfully perceived, accepted and let go. A promising, more recent trend in treatment development research is the integration of tradition CT with mindfulness-based meditation, an approach referred to as Mindfulness-Based Cognitive Therapy (MBCT). To date, we are the only research group that has adapted and tested a manualized MBCT approach for the treatment of painful medical conditions. Thus, the proposed pilot randomized controlled trial aims to utilize state-of-the-art research methodology to evaluate traditional Cognitive Therapy (CT) compared to an innovative, newly developed Mindfulness-Based Cognitive Therapy (MBCT) protocol for the treatment of chronic pain in individuals with multiple sclerosis. This study will answer three primary questions: (1) Do these treatments work to improve chronic pain for individuals with MS and do these treatment also improve associated symptoms such as depression, fatigue, and engagement in daily activities?; (2) How do these treatments work in individuals with MS, i.e., what factors underlie improvement in outcomes during treatment?; and (3) What are the individual person characteristics that best predict outcome? This will be the first study to examine MBCT within an MS population. The results will lead to the emergence of a novel, much needed additional psychosocial treatment option for patients with chronic MS pain.

Condition or disease Intervention/treatment Phase
Multiple Sclerosis Behavioral: Mindfulness Based Cognitive Therapy Behavioral: Cognitive Therapy Phase 1 Phase 2

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 8 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Treatment
Official Title: The Efficacy and Mechanisms of Cognitive Therapy Compared to Mindfulness-Based Cognitive Therapy in Multiple Sclerosis (MS) Pain
Study Start Date : October 2013
Actual Primary Completion Date : April 2015
Actual Study Completion Date : December 2016

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Active Comparator: Mindfulness Based Cognitive Therapy
Mindfulness Based Cognitive Therapy
Behavioral: Mindfulness Based Cognitive Therapy
Active Comparator: Cognitive therapy
Cognitive Therapy
Behavioral: Cognitive Therapy



Primary Outcome Measures :
  1. pain intensity [ Time Frame: at post-treatment (5 weeks on average) ]
    numeric rating scale (0-10 scale)



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 100 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. Diagnosis of MS obtained by ICD coding list
  2. At least 6 months post-diagnosis.
  3. At least 18 years old.
  4. Read, speak and understand English.
  5. Experience chronic pain on a daily basis.
  6. Most significant pain problem(s) is or are related to MS.
  7. Report an average pain intensity of at least 4 on a 0-10 Numerical Scale in the past week.
  8. Most significant pain problem(s) has or have lasted at least six months.
  9. Experience ongoing pain with an average intensity of 4 or more on a 0-10 scale when they experience pain.*
  10. Have internet access on a daily basis.

Exclusion Criteria:

1. Psychiatric condition or symptoms that would interfere with participation, specifically active suicidal ideation with intent to harm oneself or active delusional or psychotic thinking

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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02012439


Locations
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United States, Washington
UW Medicine Multiple Sclerosis Center
Seattle, Washington, United States, 98195
Sponsors and Collaborators
University of Washington
National Multiple Sclerosis Society
Investigators
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Principal Investigator: Dawn Ehde, PhD University of Washington

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Responsible Party: Dawn Ehde, Professor, Rehabilitation Medicine, University of Washington
ClinicalTrials.gov Identifier: NCT02012439     History of Changes
Other Study ID Numbers: 45416
First Posted: December 16, 2013    Key Record Dates
Last Update Posted: September 16, 2019
Last Verified: September 2019
Keywords provided by Dawn Ehde, University of Washington:
multiple sclerosis
chronic pain
treatment
nonpharmacological
mindfulness
cognitive therapy
Additional relevant MeSH terms:
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Multiple Sclerosis
Sclerosis
Pathologic Processes
Demyelinating Autoimmune Diseases, CNS
Autoimmune Diseases of the Nervous System
Nervous System Diseases
Demyelinating Diseases
Autoimmune Diseases
Immune System Diseases