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临床试验/NCT02012439
NCT02012439已完成1 期

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

University of Washington2 个研究点 分布在 1 个国家目标入组 8 人开始时间: 2013年10月最近更新:
适应症
干预措施

试验速览

阶段
1 期
状态
已完成
入组人数
8
试验地点
2
主要终点
pain intensity

研究概览

简要总结

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.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Treatment
盲法
Single (Outcomes Assessor)

入排标准

年龄范围
18 Years 至 100 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • 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.

排除标准

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

研究组 & 干预措施

Mindfulness Based Cognitive Therapy

Active Comparator

Mindfulness Based Cognitive Therapy

干预措施: Mindfulness Based Cognitive Therapy (Behavioral)

Cognitive therapy

Active Comparator

Cognitive Therapy

干预措施: Cognitive Therapy (Behavioral)

结局指标

主要结局

pain intensity

时间窗: at post-treatment (5 weeks on average)

numeric rating scale (0-10 scale)

次要结局

未报告次要终点

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Dawn Ehde

Professor, Rehabilitation Medicine

University of Washington

研究点 (2)

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