A Pilot Study on the Combined Use of Cognitive Behavioral Therapy (CBT) and Dulox

描述（由申请人提供）：纤维肌痛（FMS），定义为存在慢性广泛性疼痛和检查发现11/18个压痛点，影响2%的一般人群。在FMS管理和研究中最受关注的两种治疗方法是认知行为治疗（CBT）和药物治疗。虽然药物治疗对改善FMS相关症状最有效，但CBT已被证明对改善FMS相关残疾更有用。鉴于单一疗法（单独使用药物或CBT）似乎只能适度减轻疼痛，现在是时候考虑更仔细地研究包括药物和CBT在内的联合治疗，以优化治疗反应。更重要的是，人们对两种不同的治疗策略如何单独或联合使用以提高疗效的机制知之甚少。因此，我们建议进行一项3臂随机注意力对照试验，其主要目的是测试CBT和度洛沙汀联合治疗方法的可行性，并获得其效果的初步估计，以用于设计更大规模的试验。该初步研究将入组48例FMS患者，将其随机分配至3组之一：（1）联合使用CBT-度洛西汀，（2）CBT-安慰剂，或（3）度洛西汀-教育（注意力）组。从第1周至第9周，受试者将接受8次电话传递的CBT或教育指导。此外，从第1周至第21周，受试者将接受度洛昔单抗或安慰剂。基线（第1周）、第9周和第21周的结局评估将包括以下内容：自我报告疼痛严重程度和身体功能、疼痛相关信念和应对以及诱发疼痛敏感性。该研究计划将使我们能够探索基于心理的治疗的生物学机制以及基于生物的治疗的心理机制。公共卫生相关性：鉴于单一疗法（单独使用药物或CBT）似乎只能适度减轻疼痛，因此拟议的研究具有重要意义，因为CBT和度洛沙汀的组合具有极大的潜力，可以最大限度地提高治疗反应。更重要的是，探索联合治疗的生物学和心理学机制可能为开发FMS患者的新疗法铺平道路。

DESCRIPTION (provided by applicant): Fibromyalgia (FMS), defined as the presence of both chronic widespread pain and the finding of 11/18 tender points on examination, affects 2% of the general population. The two treatment approaches that have received the most attention in FMS management and research are cognitive behavioral therapy (CBT) and drug therapy. Whereas drug therapy is most effective for improving the symptoms associated with FMS, CBT has been shown to be more useful for improving the FMS-related disability. Given the fact that mono-therapies (drug or CBT alone) appear to only produce modest reductions in pain, it is time to consider more careful study of combination treatment that includes drug and CBT to optimize treatment response. More importantly, little is known about the mechanisms of how two different treatment strategies would work alone or in combination to enhance outcomes. Therefore, we propose to conduct a 3-arm randomized attention-controlled trial whose primary aim is to test the feasibility of combined CBT and duloxetine treatment approach, and obtain preliminary estimates of its effect for use in designing a larger trial. This pilot study will enroll 48 FMS patients, randomizing them to one of the 3 groups: (1) combination CBT-duloxetine, (2) CBT-placebo, or (3) duloxetine-education (attention) group. From week 1 to 9, subjects will receive 8 sessions of telephone-delivered CBT or educational instructions. Additionally, from week 1 to 21, subjects will receive duloxetine or placebo. Outcome assessments at baseline (week 1), week 9 and week 21 will include the following: self-report pain severity and physical function, pain-related beliefs and coping and evoked pain sensitivity. This program of research would enable us to explore biological mechanisms of a psychological-based therapy, and the psychological mechanisms of a biological-based therapy. PUBLIC HEALTH RELEVANCE: Given the fact that mono-therapies (drug or CBT alone) appear to only produce modest reductions in pain, the proposed research is significant because the combination CBT and duloxetine has considerable potential to maximize treatment response. More importantly, exploring the biological and psychological mechanisms underlying combination treatment may pave the way for developing new treatments for FMS sufferers.