Overview

This trial is active, not recruiting.

Condition multiple sclerosis
Treatments mindfulness based cognitive therapy, cognitive therapy
Phase phase 1/phase 2
Sponsor University of Washington
Collaborator National Multiple Sclerosis Society
Start date October 2013
End date April 2015
Trial size 32 participants
Trial identifier NCT02012439, 45146-G

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.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Allocation randomized
Endpoint classification efficacy study
Intervention model parallel assignment
Masking single blind (outcomes assessor)
Primary purpose treatment
Arm
(Active Comparator)
Mindfulness Based Cognitive Therapy
mindfulness based cognitive therapy
(Active Comparator)
Cognitive Therapy
cognitive therapy

Primary Outcomes

Measure
pain intensity
time frame: at post-treatment (5 weeks on average)

Eligibility Criteria

Male or female participants from 18 years up to 100 years old.

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

Additional Information

Official title The Efficacy and Mechanisms of Cognitive Therapy Compared to Mindfulness-Based Cognitive Therapy in Multiple Sclerosis (MS) Pain
Trial information was received from ClinicalTrials.gov and was last updated in May 2016.
Information provided to ClinicalTrials.gov by University of Washington.