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NCT02012439 · ClinicalTrials.gov registry record · Phase 1
Comparison of the Efficacy and Mechanisms for MBCT and CT for Multiple Sclerosis (MS) Chronic Pain
A Phase 1 study of Multiple Sclerosis, sponsored by University of Washington.
- Completed
- Registry status
- Phase 1
- Development phase
- 8
- Enrollment target
- 1
- Study location
NCT02012439 is a Phase 1 study of Multiple Sclerosis that has completed, run by University of Washington. The registered enrollment target is 8 participants, below the 585-participant average among 315 other Multiple Sclerosis trials with a reported enrollment target (99% lower). The trial reports 1 study location across 1 state.
The verdict
NCT02012439, a Phase 1 study of Multiple Sclerosis, has completed, sponsored by University of Washington.
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 8 participants
- Enrollment target
- 1
- Study location
Study 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
Conditions Studied
Interventions
- BEHAVIORAL Mindfulness Based Cognitive Therapy
- BEHAVIORAL Cognitive Therapy
Study Locations (1)
Washington
- UW Medicine Multiple Sclerosis Center - Seattle
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 8 participants |
| Start Date | 2013-10 |
| Est. Completion | 2016-12 |
| Phase | Phase 1 |
Interested in This Trial?
Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT02012439
The ClinicalTrials.gov registry entry for NCT02012439 describes a study currently listed as completed, categorized as Phase 1. The registered enrollment target is 8 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 585-participant average among 315 other Multiple Sclerosis trials with a reported enrollment target (99% lower). The listed sponsor is University of Washington, which has 1,048 total studies on file at ClinicalTrials.gov.
The record links to 1 condition, with Multiple Sclerosis appearing as the primary indexed condition, and to 2 interventions - of which Mindfulness Based Cognitive Therapy is the first listed.
NCT02012439 reports 1 study location spanning 1 distinct geographic area - top geographies include Washington.
Frequently Asked Questions
What is clinical trial NCT02012439 about?
NCT02012439 is a clinical study titled "Comparison of the Efficacy and Mechanisms for MBCT and CT for Multiple Sclerosis (MS) Chronic 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 multidim...
What is the current status of trial NCT02012439?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 8 participants. The study started on 2013-10. Estimated completion is 2016-12.
What conditions does trial NCT02012439 study?
This clinical trial studies the following conditions: Multiple Sclerosis.
What interventions are being tested in trial NCT02012439?
The interventions under investigation include: Mindfulness Based Cognitive Therapy (BEHAVIORAL), Cognitive Therapy (BEHAVIORAL).
Who is sponsoring clinical trial NCT02012439?
This trial is sponsored by University of Washington, which has 1,048 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT02012439 being conducted?
This trial has 1 study location across Washington. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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Related
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