Kaiser Permanente Center for Health Research, Portland, USA.
Kaiser Permanente Washington Health Research Institute, Seattle, USA.
Trials. 2023 Mar 16;24(1):196. doi: 10.1186/s13063-023-07165-8.
Cognitive behavioral therapy for chronic pain (CBT-CP) is an effective but underused treatment for high-impact chronic pain. Increased access to CBT-CP services for pain is of critical public health importance, particularly for rural and medically underserved populations who have limited access due to these services being concentrated in urban and high income areas. Making CBT-CP widely available and more affordable could reduce barriers to CBT-CP use.
As part of the National Institutes of Health Helping to End Addiction Long-term® (NIH HEAL) initiative, we designed and implemented a comparative effectiveness, 3-arm randomized control trial comparing remotely delivered telephonic/video and online CBT-CP-based services to usual care for patients with high-impact chronic pain. The RESOLVE trial is being conducted in 4 large integrated healthcare systems located in Minnesota, Georgia, Oregon, and Washington state and includes demographically diverse populations residing in urban and rural areas. The trial compares (1) an 8-session, one-on-one, professionally delivered telephonic/video CBT-CP program; and (2) a previously developed and tested 8-session online CBT-CP-based program (painTRAINER) to (3) usual care augmented by a written guide for chronic pain management. Participants are followed for 1 year post-allocation and are assessed at baseline, and 3, 6, and 12 months post-allocation. The primary outcome is minimal clinically important difference (MCID; ≥ 30% reduction) in pain severity (composite of pain intensity and pain-related interference) assessed by a modified 11-item version of the Brief Pain Inventory-Short Form at 3 months. Secondary outcomes include pain severity, pain intensity, and pain-related interference scores, quality of life measures, and patient global impression of change at 3, 6, and 12 months. Cost-effectiveness is assessed by incremental cost per additional patient with MCID in primary outcome and by cost per quality-adjusted life year achieved. Outcome assessment is blinded to group assignment.
This large-scale trial provides a unique opportunity to rigorously evaluate and compare the clinical and cost-effectiveness of 2 relatively low-cost and scalable modalities for providing CBT-CP-based treatments to persons with high-impact chronic pain, including those residing in rural and other medically underserved areas with limited access to these services.
ClinicalTrials.gov NCT04523714. This trial was registered on 24 August 2020.
慢性疼痛的认知行为疗法（CBT-CP）是一种针对高影响力慢性疼痛的有效但未被充分利用的治疗方法。增加慢性疼痛患者获得 CBT-CP 服务的机会对于公共卫生至关重要，尤其是对于那些由于这些服务集中在城市和高收入地区而导致获得服务机会有限的农村和医疗服务不足的人群。使 CBT-CP 广泛可用且更负担得起可以减少 CBT-CP 使用的障碍。
作为美国国立卫生研究院“帮助终结成瘾长期计划”（NIH HEAL）倡议的一部分，我们设计并实施了一项具有可比性的有效性、3 臂随机对照试验，比较了远程电话/视频和在线基于 CBT-CP 的服务与高影响力慢性疼痛患者的常规护理。RESOLVE 试验正在明尼苏达州、佐治亚州、俄勒冈州和华盛顿州的 4 个大型综合医疗系统中进行，包括居住在城市和农村地区的人口统计学上多样化的人群。该试验比较了（1）8 节一对一、专业提供的电话/视频 CBT-CP 方案；（2）以前开发和测试的 8 节在线基于 CBT-CP 的方案（painTRAINER）与（3）常规护理，常规护理通过慢性疼痛管理的书面指南进行补充。参与者在分配后 1 年内进行随访，并在基线、3、6 和 12 个月时进行评估。主要结局是通过改良的简短疼痛量表-短表的 11 项版本评估的疼痛严重程度（疼痛强度和疼痛相关干扰的综合）的最小临床重要差异（MCID；≥30% 减少）在 3 个月时。次要结局包括疼痛严重程度、疼痛强度和疼痛相关干扰评分、生活质量测量和患者在 3、6 和 12 个月时对变化的整体印象。成本效益通过主要结局中获得 MCID 的每位额外患者的增量成本和每实现一个质量调整生命年的成本进行评估。结果评估对分组分配是盲法的。
这项大规模试验为严格评估和比较为高影响力慢性疼痛患者提供基于 CBT-CP 的治疗的两种相对低成本和可扩展的模式的临床和成本效益提供了独特的机会，包括那些居住在农村和其他医疗服务不足地区的患者，这些地区获得这些服务的机会有限。
ClinicalTrials.gov NCT04523714。该试验于 2020 年 8 月 24 日注册。
