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

The Efficacy and Mechanisms of Cognitive Therapy Compared to Mindfulness-Based Cognitive Therapy in Multiple Sclerosis (MS) Pain

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.

Study Overview

• Status: Completed
• Conditions: Multiple Sclerosis
• Intervention / Treatment: Behavioral: Mindfulness Based Cognitive Therapy; Behavioral: Cognitive Therapy

• Study Type: Interventional
• Enrollment (Actual): 8
• Phase: Phase 2; Phase 1

Contacts and Locations

Study Locations

• United States
  • Washington
    • Seattle, Washington, United States, 98195
      • UW Medicine Multiple Sclerosis Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 100 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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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Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Mindfulness Based Cognitive Therapy	Behavioral: Mindfulness Based Cognitive Therapy
Active Comparator: Cognitive therapy; Cognitive Therapy	Behavioral: Cognitive Therapy

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
pain intensity	numeric rating scale (0-10 scale)	at post-treatment (5 weeks on average)

Collaborators and Investigators

• Sponsor: University of Washington
• Collaborators: National Multiple Sclerosis Society
• Investigators: Principal Investigator: Dawn Ehde, PhD, University of Washington

Study record dates

Study Major Dates

• Study Start: October 1, 2013
• Primary Completion (Actual): April 1, 2015
• Study Completion (Actual): December 1, 2016

Study Registration Dates

• First Submitted: October 22, 2013
• First Submitted That Met QC Criteria: December 9, 2013
• First Posted (Estimate): December 16, 2013

Study Record Updates

• Last Update Posted (Actual): September 16, 2019
• Last Update Submitted That Met QC Criteria: September 11, 2019
• Last Verified: September 1, 2019

More Information

Terms related to this study

• Keywords: chronic pain; treatment; mindfulness; multiple sclerosis; nonpharmacological; cognitive therapy
• Additional Relevant MeSH Terms: Pathologic Processes; Nervous System Diseases; Immune System Diseases; Demyelinating Autoimmune Diseases, CNS; Autoimmune Diseases of the Nervous System; Demyelinating Diseases; Autoimmune Diseases; Multiple Sclerosis; Sclerosis
• Other Study ID Numbers: 45416

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No