Learning to Apply Mindfulness to Pain (LAMP): Design for a Pragmatic Clinical Trial of Two Mindfulness-Based Interventions for Chronic Pain
Learning to Apply Mindfulness to Pain (LAMP): Design for a Pragmatic Clinical Trial of Two Mindfulness-Based Interventions for Chronic Pain
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DOI：
10.1093/pm/pnaa337
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发表时间：
2020-12-01
期刊：
影响因子：
3.1
通讯作者：
Taylor, Brent C.
中科院分区：
文献类型：
--
作者：
Burgess, Diana J.;Evans, Roni;Taylor, Brent C.
背景基于正念的干预（MBIs）是治疗慢性疼痛的循证非药物治疗。然而，主要的MBI，基于正念的减压，具有构成重大实施障碍的特征。目标.这项研究将测试两种方法来提供MBIs，以改善退伍军人的慢性疼痛和心理健康共病。这两种方法解决了关键的实施障碍。方法.我们将进行一项四个地点，三个手臂的实用随机对照试验，学习将正念应用于疼痛（LAMP），以测试两种MBIs在改善疼痛和心理健康共病方面的有效性。移动的+小组LAMP由正念导师提供的预录模块组成，这些模块在在线小组环境中观看，并穿插着由主持人领导的讨论。移动的LAMP由相同的预录模块组成，但不包括组组件。我们将测试这两种MBI在改善慢性疼痛方面是否比常规护理更有效，以及移动的+组LAMP在改善慢性疼痛方面是否比移动的LAMP更有效。将在10周、6个月和12个月时重复连续结局（简明疼痛量表干扰评分），对主要假设进行比较。次要假设是移动的+组LAMP和移动的LAMP在改善次要结局方面比常规护理更有效（例如，创伤后应激障碍、抑郁症）。我们还将确认在特定性别分层中主要和次要假设的比较。影响。这项试验预计将产生两种提供MBIs的方法，这些方法将优化参与度，依从性和可持续性，并能够接触到大量退伍军人。
Background. Mindfulness-based interventions (MBIs) are evidence-based nonpharmacological treatments for treating chronic pain. However, the predominant MBI, mindfulness-based stress reduction, has features that pose significant implementation barriers. Objectives. This study will test two approaches to delivering MBIs for improving Veterans' chronic pain and mental health comorbidities. These two approaches address key implementation barriers. Methods. We will conduct a four-site, three-arm pragmatic randomized controlled trial, Learning to Apply Mindfulness to Pain (LAMP), to test the effectiveness of two MBIs at improving pain and mental health comorbidities. Mobile+Group LAMP consists of prerecorded modules presented by a mindfulness instructor that are viewed in an online group setting and interspersed with discussions led by a facilitator. Mobile LAMP consists of the same prerecorded modules but does not include a group component. We will test whether either of these MBIs will be more effective than usual care at improving chronic pain and whether the Mobile+Group LAMP will be more effective than Mobile LAMP at improving chronic pain. Comparisons for the primary hypotheses will be conducted with continuous outcomes (Brief Pain Inventory interference score) repeated at 10weeks, 6 months, and 12 months. The secondary hypotheses are that Mobile+Group LAMP and Mobile LAMP will be more effective than usual care at improving secondary outcomes (e.g., post-traumatic stress disorder, depression). We will also confirm the comparisons for the primary and secondary hypotheses in gender-specific strata. Implications. This trial is expected to result in two approaches for delivering MBIs that will optimize engagement, adherence, and sustainability and be able to reach large numbers of Veterans.