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

NCT02012439 | Completed Phase 1

• 1 other identifier: 45416
• Study Type: interventional
• Target: 8
• Locations: 1 country
• Sites: 1

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.

Conditions

Multiple Sclerosis

Keywords

multiple sclerosis; chronic pain; treatment; nonpharmacological; mindfulness; cognitive therapy

Outcome Measures

Primary Outcomes (1)

• pain intensity

  numeric rating scale (0-10 scale)

  at post-treatment (5 weeks on average)

Study Arms (2)

Mindfulness Based Cognitive Therapy

ACTIVE COMPARATOR

Mindfulness Based Cognitive Therapy

Behavioral: Mindfulness Based Cognitive Therapy

Cognitive therapy

ACTIVE COMPARATOR

Cognitive Therapy

Behavioral: Cognitive Therapy

Interventions

Mindfulness Based Cognitive Therapy BEHAVIORAL

Mindfulness Based Cognitive Therapy

Cognitive Therapy BEHAVIORAL

Cognitive therapy

Eligibility Criteria

• Age: 18 Years - 100 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

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

Sponsors & Collaborators

• University of Washington: lead
• National Multiple Sclerosis Society: collaborator

Study Sites (1)

UW Medicine Multiple Sclerosis Center

Seattle, Washington, 98195, United States

Location

MeSH Terms

Conditions

Multiple Sclerosis; Chronic Pain

Interventions

Mindfulness-Based Cognitive Therapy; Cognitive Behavioral Therapy

Condition Hierarchy (Ancestors)

Demyelinating Autoimmune Diseases, CNS; Autoimmune Diseases of the Nervous System; Nervous System Diseases; Demyelinating Diseases; Autoimmune Diseases; Immune System Diseases; Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Mindfulness; Behavior Therapy; Psychotherapy; Behavioral Disciplines and Activities

Study Officials

• Dawn Ehde, PhD

  University of Washington

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor, Rehabilitation Medicine

Study Record Dates

• First Submitted: October 22, 2013
• First Posted: December 16, 2013
• Study Start: October 1, 2013
• Primary Completion: April 1, 2015
• Study Completion: December 1, 2016
• Last Updated: September 16, 2019

Record last verified: 2019-09

Locations

US (1)