Comparison of the Efficacy and Mechanisms for MBCT and CT for Multiple Sclerosis (MS) Chronic Pain
Primary Purpose
Multiple Sclerosis
Status
Completed
Phase
Phase 1
Locations
United States
Study Type
Interventional
Intervention
Mindfulness Based Cognitive Therapy
Cognitive Therapy
Sponsored by

About this trial
This is an interventional treatment trial for Multiple Sclerosis focused on measuring multiple sclerosis, chronic pain, treatment, nonpharmacological, mindfulness, cognitive therapy
Eligibility Criteria
Inclusion Criteria:
- Diagnosis of MS obtained by ICD coding list
- At least 6 months post-diagnosis.
- At least 18 years old.
- Read, speak and understand English.
- Experience chronic pain on a daily basis.
- Most significant pain problem(s) is or are related to MS.
- Report an average pain intensity of at least 4 on a 0-10 Numerical Scale in the past week.
- Most significant pain problem(s) has or have lasted at least six months.
- Experience ongoing pain with an average intensity of 4 or more on a 0-10 scale when they experience pain.*
- 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
-
Sites / Locations
- UW Medicine Multiple Sclerosis Center
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Active Comparator
Arm Label
Mindfulness Based Cognitive Therapy
Cognitive therapy
Arm Description
Mindfulness Based Cognitive Therapy
Cognitive Therapy
Outcomes
Primary Outcome Measures
pain intensity
numeric rating scale (0-10 scale)
Secondary Outcome Measures
Full Information
NCT ID
NCT02012439
First Posted
October 22, 2013
Last Updated
September 11, 2019
Sponsor
University of Washington
Collaborators
National Multiple Sclerosis Society
1. Study Identification
Unique Protocol Identification Number
NCT02012439
Brief Title
Comparison of the Efficacy and Mechanisms for MBCT and CT for Multiple Sclerosis (MS) Chronic Pain
Official Title
The Efficacy and Mechanisms of Cognitive Therapy Compared to Mindfulness-Based Cognitive Therapy in Multiple Sclerosis (MS) Pain
Study Type
Interventional
2. Study Status
Record Verification Date
September 2019
Overall Recruitment Status
Completed
Study Start Date
October 2013 (undefined)
Primary Completion Date
April 2015 (Actual)
Study Completion Date
December 2016 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Washington
Collaborators
National Multiple Sclerosis Society
4. Oversight
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Multiple Sclerosis
Keywords
multiple sclerosis, chronic pain, treatment, nonpharmacological, mindfulness, cognitive therapy
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 1, Phase 2
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
8 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Mindfulness Based Cognitive Therapy
Arm Type
Active Comparator
Arm Description
Mindfulness Based Cognitive Therapy
Arm Title
Cognitive therapy
Arm Type
Active Comparator
Arm Description
Cognitive Therapy
Intervention Type
Behavioral
Intervention Name(s)
Mindfulness Based Cognitive Therapy
Intervention Type
Behavioral
Intervention Name(s)
Cognitive Therapy
Primary Outcome Measure Information:
Title
pain intensity
Description
numeric rating scale (0-10 scale)
Time Frame
at post-treatment (5 weeks on average)
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
100 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Diagnosis of MS obtained by ICD coding list
At least 6 months post-diagnosis.
At least 18 years old.
Read, speak and understand English.
Experience chronic pain on a daily basis.
Most significant pain problem(s) is or are related to MS.
Report an average pain intensity of at least 4 on a 0-10 Numerical Scale in the past week.
Most significant pain problem(s) has or have lasted at least six months.
Experience ongoing pain with an average intensity of 4 or more on a 0-10 scale when they experience pain.*
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
-
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Dawn Ehde, PhD
Organizational Affiliation
University of Washington
Official's Role
Principal Investigator
Facility Information:
Facility Name
UW Medicine Multiple Sclerosis Center
City
Seattle
State/Province
Washington
ZIP/Postal Code
98195
Country
United States
12. IPD Sharing Statement
Learn more about this trial
Comparison of the Efficacy and Mechanisms for MBCT and CT for Multiple Sclerosis (MS) Chronic Pain
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