Chronic pain is a major health problem, and cognitive behavioral therapy (CBT) is its recommended treatment; however, efforts to develop CBT programs for chronic pain and assess their feasibility are remarkably delayed in Asia. Therefore, we conducted this pilot study to develop a basic individualized CBT for chronic pain (CBT-CP) and assessed its feasibility for use in Japan. Our study was an open-labeled before–after trial without a control group conducted cooperatively in five Japanese tertiary care hospitals. Of 24 outpatients, 15, age 20–80, who experienced chronic pain for at least three months were eligible. They underwent an eight-session CBT-CP consisting of relaxation via a breathing method and progressive muscle relaxation, behavioral modification via activity pacing, and cognitive modification via cognitive reconstruction. The EuroQol five-dimensional questionnaire five level (EQ5D-5 L) assessment as the primary outcome and quality of life (QOL), pain severity, disability, catastrophizing, self-efficacy, and depressive symptoms as secondary outcomes were measured using self-administered questionnaires at baseline, post-treatment, and 3-month follow-up. Intention-to-treat analyses were conducted. Effect size for EQ5D-5 L score was medium from baseline to post-treatment (Hedge’s g = − 0.72, 90% confidence interval = − 1.38 to − 0.05) and up to the 3-month follow-up (g = − 0.60, CI = − 1.22 to 0.02). Effect sizes for mental and role/social QOL, disability, catastrophizing, self-efficacy, and depressive symptoms were medium to large, although those for pain severity and physical QOL were small. The dropout rate was acceptably low at 14%. No severe adverse events occurred. The findings suggest that CBT-CP warrants a randomized controlled trial in Japan. University Hospital Medical Information Network Clinical Trials Registry (UMIN-CTR), UMIN000020880. Registered on 04 February 2016.

中文翻译：

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日本针对慢性疼痛的基本个体化认知行为治疗计划的试点研究

慢性疼痛是一个主要的健康问题，认知行为疗法 (CBT) 是其推荐的治疗方法；然而，在亚洲，开发慢性疼痛 CBT 项目并评估其可行性的努力明显延迟。因此，我们进行了这项试点研究，以开发一种基本的慢性疼痛个体化 CBT (CBT-CP)，并评估其在日本使用的可行性。我们的研究是在日本五家三级医院合作开展的无对照组的开放标签前后试验。在 24 名门诊患者中，有 15 名年龄在 20-80 岁之间且经历了至少三个月的慢性疼痛的患者符合条件。他们接受了八次 CBT-CP，包括通过呼吸法放松和渐进式肌肉放松、通过活动起搏进行行为矫正和通过认知重建进行认知矫正。EuroQol 五维问卷五级 (EQ5D-5 L) 评估作为主要结果和生活质量 (QOL)、疼痛严重程度、残疾、灾难性、自我效能和抑郁症状作为次要结果使用自我管理测量基线、治疗后和 3 个月随访时的问卷调查。进行了意向治疗分析。EQ5D-5 L 评分的影响大小从基线到治疗后为中等（Hedge 的 g = - 0.72，90% 置信区间 = - 1.38 到 - 0.05）和长达 3 个月的随访（g = - 0.60， CI = - 1.22 至 0.02）。心理和角色/社会生活质量、残疾、灾难性、自我效能和抑郁症状的影响大小为中到大，尽管疼痛严重程度和身体生活质量的影响很小。辍学率低到可以接受，只有 14%。没有发生严重的不良事件。研究结果表明，CBT-CP 值得在日本进行随机对照试验。大学医院医学信息网络临床试验注册中心（UMIN-CTR），UMIN000020880。于 2016 年 2 月 4 日注册。