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Completed Phase 1Phase 2 Interventional

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

ClinicalTrials.gov ID: NCT02012439

Public ClinicalTrials.gov record NCT02012439. Field values are reproduced from the official study page; the official ClinicalTrials.gov record remains the source of truth for eligibility, enrollment, and contact information.

ClinicalTrials.gov public records Last synced Sep 23, 2026, 11:23 AM EDT

Data is sourced from official ClinicalTrials.gov public API records. Always review the official ClinicalTrials.gov record for the latest information.

Official title

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

Brief summary

Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.

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 identification

NCT ID
NCT02012439
Recruitment status
Completed
Study type
Interventional
Phase
Phase 1, Phase 2
Lead sponsor
University of Washington
Other
Enrollment
8 participants

Conditions and interventions

Interventions

Behavioral

Eligibility (public fields only)

Age range
18 Years to 100 Years
Sex
All
Healthy volunteers
Healthy volunteers not accepted

This page does not interpret eligibility. Detailed inclusion and exclusion criteria are on the official ClinicalTrials.gov record.

Study timeline

Start date
Sep 30, 2013
Primary completion
Mar 31, 2015
Completion
Nov 30, 2016
Last update posted
Sep 15, 2019

2013 – 2016

United States locations

U.S. sites
1
U.S. states
1
U.S. cities
1
Facility City State ZIP Site status
UW Medicine Multiple Sclerosis Center Seattle Washington 98195

Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.

About this trial record page

What this page shows
Public field values for ClinicalTrials.gov record NCT02012439, including study identification, conditions, interventions, eligibility (age, sex, healthy volunteer), timeline, and U.S. site list.
What this page does not do
No medical advice, eligibility judgments, treatment recommendations, study quality scoring, or AI-generated medical summaries. No site contact phone numbers, emails, or investigator names.
Where the data comes from
Sourced from the official ClinicalTrials.gov public API. The official record is the source of truth.
Last refresh
Last update posted Sep 15, 2019 · Synced Sep 23, 2026

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Open the official record

The complete protocol, eligibility criteria, and contact information for NCT02012439 live on ClinicalTrials.gov.

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