基于正念的认知疗法与认知行为疗法对多发性硬化症慢性疼痛的疗效：一项随机对照试验方案
Mindfulness-based cognitive therapy and cognitive behavioral therapy for chronic pain in multiple sclerosis: a randomized controlled trial protocol.
作者信息
Ehde Dawn M, Alschuler Kevin N, Day Melissa A, Ciol Marcia A, Kaylor Makena L, Altman Jennifer K, Jensen Mark P
机构信息
Department of Rehabilitation Medicine, School of Medicine, University of Washington, 325 9th Ave, Box 359612, Seattle, WA, 98104, USA.
Department of Neurology, School of Medicine, University of Washington, UW Multiple Sclerosis Center, 1536 N 115th St, McMurray Building Suite 130, Seattle, WA, 98133, USA.
出版信息
Trials. 2019 Dec 27;20(1):774. doi: 10.1186/s13063-019-3761-1.
BACKGROUND
Chronic pain is one of the most prevalent and disabling symptoms associated with multiple sclerosis (MS). Individuals with MS are interested in nonpharmacologic pain management approaches. Cognitive-behavioral therapy (CBT) is efficacious in improving MS-related pain outcomes. Mindfulness-based cognitive therapy (MBCT) is a promising, alternative approach. Little is known about moderators of these treatments' outcomes, however. This article describes the study protocol for the first randomized controlled trial comparing MBCT, CBT, and usual care and examining treatment effect moderators in individuals with chronic pain and MS.
METHODS
We will conduct a single-center, randomized, single blind, parallel-group trial comparing MBCT, CBT, and usual care in adults with MS and chronic pain. Both interventions will be delivered via eight group sessions using videoconferencing technology. Primary (average pain intensity) and secondary outcomes (including pain interference, depressive symptoms, fatigue, and sleep) will be assessed pre-treatment, mid-treatment, post-treatment, and at 6-month follow up. Potential treatment moderators will be assessed pre-treatment. We hypothesize that participants randomly assigned to MBCT or CBT will report significantly greater reductions in average pain intensity than participants assigned to usual care at post-treatment (primary study endpoint) and 6-month follow up. We also hypothesize that mindfulness, pain catastrophizing, and behavioral activation pre-treatment will moderate response to both active treatments, but not response to usual care.
DISCUSSION
Findings will provide important new information about the efficacy and moderators of two nonpharmacologic pain management approaches delivered using technology to overcome common barriers to treatment access. The knowledge gained may lead to better patient-treatment matching and, ultimately, better pain treatment outcomes in MS.
TRIAL REGISTRATION
ClinicalTrials.gov, NCT03782246. Registered on 20 December 2018.
背景
慢性疼痛是与多发性硬化症（MS）相关的最常见且致残的症状之一。MS患者对非药物疼痛管理方法感兴趣。认知行为疗法（CBT）在改善与MS相关的疼痛结局方面有效。基于正念的认知疗法（MBCT）是一种有前景的替代方法。然而，对于这些治疗效果的调节因素知之甚少。本文描述了第一项随机对照试验的研究方案，该试验比较了MBCT、CBT和常规护理，并研究了慢性疼痛和MS患者的治疗效果调节因素。
方法
我们将进行一项单中心、随机、单盲、平行组试验，比较MBCT、CBT和常规护理对患有MS和慢性疼痛的成年人的效果。两种干预措施都将通过八次使用视频会议技术的小组会议进行。主要结局（平均疼痛强度）和次要结局（包括疼痛干扰、抑郁症状、疲劳和睡眠）将在治疗前、治疗中期、治疗后以及6个月随访时进行评估。潜在的治疗调节因素将在治疗前进行评估。我们假设，随机分配到MBCT或CBT组的参与者在治疗后（主要研究终点）和6个月随访时报告的平均疼痛强度降低幅度将显著大于分配到常规护理组的参与者。我们还假设，治疗前的正念、疼痛灾难化和行为激活将调节对两种积极治疗的反应，但不会调节对常规护理的反应。
讨论
研究结果将提供重要的新信息，说明使用技术提供的两种非药物疼痛管理方法的疗效和调节因素，以克服治疗获取的常见障碍。所获得的知识可能会导致更好的患者与治疗匹配，并最终在MS中实现更好的疼痛治疗效果。
试验注册
ClinicalTrials.gov，NCT03782246。于2018年12月20日注册。
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