Brief Cognitive Behavioral Therapy for Chronic Pain to Improve Functional Outcomes among Primary Care Veterans

国家指导方针，如疾病控制中心的指导方针，推荐心理治疗 阿片类药物治疗作为首选的一线治疗慢性疼痛。行为健康提供者嵌入在 初级保健作为VA国家初级保健-心理健康一体化（PCMHI）计划的一部分， 通过提供治疗以改善功能恢复来支持患有疼痛的退伍军人。认知 慢性疼痛的行为疗法被广泛认为是一种安全有效的心理治疗方法。 然而，这种治疗通常是一种冗长的心理治疗（≥10，50分钟的疗程）， 专门护理机构。相比之下，PCMHI服务简短且有时间限制（≤6，30分钟的会话） 与治疗大量患者的初级保健服务相一致。将治疗范围扩大到 初级保健退伍军人谁目前与疼痛的关注，我们已经开发了一个基于PCMHI的版本， 慢性疼痛的简短认知行为疗法（简短CBT-CP）。简介CBT-CP将内容浓缩为 只有六次会议是围绕PCMHI提供商使用的30分钟预约结构组织的。简短的CBT- CP最近在一个临床示范项目中进行了评估，发现了统计学和临床显著性 治疗后疼痛强度和疼痛相关活动相互参照的复合测量值降低。 平均而言，大多数改善是在前三个疗程中实现的，这表明 简短的CBT-CP可能会产生快速的临床获益。我们资助的RR&D SPiRE（正在进行中）表明， 我们的试验方法具有很高的可行性，因为我们经常超过计划的每月招募目标， 潴留此外，患者报告了高水平的治疗满意度和PCMHI供应商报告 简明CBT-CP是一种重要而可行的干预措施。根据这些初步研究， 一份申请建议在退伍军人中进行一项单盲、双臂、随机对照试验[178] 患有慢性肌肉骨骼疼痛和疼痛相关的功能障碍，并接受初级保健服务， 退伍军人事务部西纽约医疗保健系统。退伍军人将被随机分配至（1）短期CBT-CP和 常规初级保健治疗（TAU）或（2）仅TAU。将在基线、治疗中期收集患者数据 （6周）、治疗后（12周）和随访（6个月），通过多水平模型进行评价，如果是短期 CBT-CP可快速减少疼痛相关活动干扰（主要结局）。次要临床 结局（疼痛强度、抑郁症状、自杀意念、生活质量和社会角色参与） 将以同样的方式进行评估。研究的第二个目标是评估潜在的治疗介质 (i.e.,疼痛自我效能和灾难化）和调节剂（即，人口统计学因素，治疗期望， 阿片类药物和连续治疗使用，治疗联盟），以确定这些因素是否影响结果。的 研究的第三个目的是通过对病人的定性访谈， 阐明简明CBT-CP如何有助于改善功能状态和改善生活角色 订婚本研究与RR&D的使命一致，并支持全国VA临床目标 通过在护理轨迹的早期促进安全，可获得，非药物治疗慢性疼痛。

National guidelines, such as those from the Centers for Disease Control, recommend psychological therapies over opioid therapy as a preferred first line treatment for chronic pain. Behavioral health providers embedded in primary care as part of the VA’s national Primary Care-Mental Health Integration (PCMHI) program are well- positioned to support Veterans with pain by delivering treatments to improve functional recovery. Cognitive behavioral therapy for chronic pain is widely recognized as a safe and effective psychological treatment. However, this treatment is typically a lengthy psychotherapy (≥10, 50-minute sessions) designed for specialized care settings. In contrast, PCMHI services are brief and time-limited (≤6, 30-minute sessions) to be consistent with primary care services that treat a high volume of patients. To extend the reach of treatment to primary care Veterans who present with a pain concern, we have developed a PCMHI-based version titled Brief Cognitive Behavioral Therapy for Chronic Pain (Brief CBT-CP). Brief CBT-CP condenses content into only six sessions organized around the 30-minute appointment structure used by PCMHI providers. Brief CBT- CP was recently evaluated in a clinical demonstration project that found a statistically and clinically significant decrease in a composite measure of pain intensity and pain-related activity interreference following treatment. On average, the majority of improvement was achieved in the first three sessions of treatment signaling that Brief CBT-CP can potentially produce rapid clinical benefit. Our funded RR&D SPiRE (in progress) indicates the high feasibility of our trial methods as we frequently exceeded planned monthly recruitment goals with high retention. Additionally, patients have reported high levels of treatment satisfaction and PCMHI providers report that Brief CBT-CP is an important and feasible intervention. Based on these preliminary studies, this application proposes to conduct a single-blind, double-arm, randomized controlled trial among [178] Veterans with chronic musculoskeletal pain and pain-related functional impairment who receive primary care services at the VA Western New York Healthcare System. Veterans will be randomized to either (1) Brief CBT-CP and primary care treatment as usual (TAU) or (2) TAU only. Patient data will be collected at baseline, mid-treatment (6-week), post-treatment (12-week), and follow-up (6-month) to evaluate through multilevel modeling if Brief CBT-CP produces a rapid decrease in pain-related activity interference (primary outcome). Secondary clinical outcomes (pain intensity, depression symptoms, suicidal ideation, quality of life, and social role engagement) will be assessed in the same manner. The second goal of the study is to assess potential treatment mediators (i.e., pain self-efficacy and catastrophizing) and moderators (i.e., demographic factors, treatment expectations, opioid and adjunctive treatment use, therapeutic alliance) to determine if these factors impact outcomes. The third aim of the study incorporates a mixed methods component by including qualitative interviews with patients to illuminate how Brief CBT-CP contributes to improvement in functional status and improved life role engagement. This study is well-aligned with the mission of RR&D and supports the VA clinical goals nationally by promoting a safe, accessible, non-pharmacological treatment for chronic pain early in the trajectory of care.