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临床试验/NCT03782246
NCT03782246Unknown不适用

Mindfulness-based Cognitive Therapy and Cognitive Behavioral Therapy for Chronic Pain in Multiple Sclerosis

University of Washington2 个研究点 分布在 1 个国家目标入组 273 人开始时间: 2018年11月28日最近更新:
适应症

试验速览

阶段
不适用
入组人数
273
试验地点
2
主要终点
Change in average pain intensity

研究概览

简要总结

Chronic pain is one of the most prevalent, disabling and persistent symptoms affecting people with multiple sclerosis (MS). Different nonpharmacological treatments are known to be beneficial for managing pain, including cognitive behavioral therapy and mindfulness based cognitive therapy. This study compares these two non-pharmacological approaches to pain management in people with Multiple Sclerosis. The purpose of this study is to see if these treatments can help decrease pain and other outcomes (e.g., sleep, fatigue) in persons with Multiple Sclerosis. The study will determine who benefits from these treatments and if these treatments can be given effectively by videoconference.

详细描述

Chronic pain is one of the most prevalent, disabling, and persistent symptoms associated with multiple sclerosis (MS). Approximately 50 - 60% of adults with multiple sclerosis experience moderate or severe, persistent pain. Medications rarely provide adequate pain relief and can entail negative side-effects. As a result, individuals with Multiple Sclerosis have become increasingly interested in nonpharmacologic approaches to pain management.

Previously completed clinical trials, and those of others, support the efficacy of cognitive-behavioral therapy (CBT) for pain in people with Multiple Sclerosis. Cognitive-behavioral therapy has been shown to decrease pain, decrease pain interference, and improve mood, sleep, and fatigue. Mindfulness-based cognitive therapy (MBCT) is another promising non-pharmacologic treatment that has been shown to improve pain outcomes in people with chronic pain; mindfulness-based cognitive therapy may also benefit individuals with Multiple Sclerosis and chronic pain. Although both of these treatments are effective pain treatments, the investigators do not know if one is more effective for the other. Furthermore, it is likely that there are both responders and non-responders to each of the treatments. That is, for any individual, two different treatments such as cognitive-behavioral therapy and mindfulness-based cognitive therapy may not necessarily be similarly beneficial in addressing pain. There is an urgent need to understand variability in responses across different psychosocial treatment interventions which will, in turn, lead to more effective and better-targeted interventions for chronic pain in Multiple Sclerosis. In other words, the investigators need to better understand for whom each of these pain interventions work best. Such knowledge will lead to better patient-treatment matching and, ultimately, better treatment outcomes.

This study is the first randomized controlled trial (RCT) comparing eight 2-hour sessions of group video-conference delivered mindfulness-based cognitive therapy and cognitive-behavioral therapy to usual care for chronic pain in 240 adults with Multiple Sclerosis. This study will identify not only the unique benefits conferred by each these two treatments but also for whom each treatment is most suitable. This study will address two specific aims:

Aim 1: To determine the efficacy of group-based, videoconference-delivered mindfulness-based cognitive therapy and cognitive-behavioral therapy interventions, relative to usual care, in reducing pain intensity (the primary outcome) in adults with chronic pain and Multiple Sclerosis. Hypothesis 1: Primary Study Hypothesis: Participants randomly assigned to mindfulness-based cognitive therapy or cognitive-behavioral therapy will report significantly greater reductions in average pain intensity (primary outcome) relative to participants assigned to usual care at post-treatment (12 weeks post randomization, primary endpoint).

Aim 2: To increase the ability to more effectively match patients to treatments by identifying pain treatment moderators. Although on average similar outcomes are expected in mindfulness-based cognitive therapy and cognitive-behavioral therapy, it is expected that there will be individual differences in who responds to each treatment. Specifically, that baseline mindfulness, behavioral activation, and pain catastrophizing will be associated with treatment response for the active treatment arms. Thus, to address Aim 2, the investigators will explore the ability of baseline mindfulness, behavioral activation, and pain catastrophizing to predict response to mindfulness-based cognitive therapy and cognitive-behavioral therapy. The investigators hypothesize that (1) baseline pain catastrophizing will be positively associated with treatment response for the two active treatment arms, but not the usual care condition (Hypothesis 2a); (2) baseline behavioral activation will be positively associated with treatment response for the two active treatment arms, but not the usual care condition (Hypothesis 2b), and (3) baseline mindfulness will be positively associated with treatment response to mindfulness-based cognitive therapy but not to either cognitive-behavioral therapy or the usual care condition (Hypothesis 2c).

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 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • 未提供

排除标准

  • 未提供

结局指标

主要结局

Change in average pain intensity

时间窗: Baseline to 10 weeks (posttreatment; primary endpoint)

0-10 Numerical Pain Scale of average pain intensity in past week (0 = no pain, 10 = worst pain imaginable). Higher scores indicate higher levels of self-reported pain intensity.

次要结局

  • Fatigue severity(baseline (week 0), 10 weeks (posttreatment), and 36 weeks (6-month follow up))
  • Self-efficacy(baseline (week 0), 10 weeks (posttreatment), and 36 weeks (6-month follow up))
  • Pain interference(baseline (week 0), 10 weeks (posttreatment), and 36 weeks (6-month follow up))
  • Depressive symptom severity(baseline (week 0), 10 weeks (posttreatment), and 36 weeks (6-month follow up))
  • Physical Function(baseline (week 0), 10 weeks (posttreatment), and 36 weeks (6-month follow up))
  • Average pain intensity - maintenance(36 weeks (6-month follow up))
  • Patient ratings of global improvement & satisfaction(baseline (week 0), 10 weeks (posttreatment), and 36 weeks (6-month follow up))
  • Sleep disturbance(baseline (week 0), 10 weeks (posttreatment), and 36 weeks (6-month follow up))
  • Global Quality of LIfe(baseline (week 0), 10 weeks (posttreatment), and 36 weeks (6-month follow up))

研究者

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

Dawn Ehde

Professor, School of Medicine: Rehabilitation Medicine:Psychology

University of Washington

研究点 (2)

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