A Controlled Trial of CBT for MS Inflammation

CBT 治疗多发性硬化症炎症的对照试验

• 批准号: 6905611
• 负责人: DAVID CURTIS MOHR
• 金额: $ 158.7万
• 依托单位: NORTHERN CALIFORNIA INSTITUTE/RES/EDU
• 依托单位国家: 美国
• 财政年份: 2003
• 资助国家: 美国
• 起止时间: 2003-09-01 至 2008-06-30
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/6905611
• 关键词: behavioral /social science research tag; biomarker; blood brain barrier; clinical research; clinical trials; cognitive behavior therapy; gadolinium; health behavior; human subject; human therapy evaluation; immunologic assay /test; inflammation; longitudinal human study; magnetic resonance imaging; memory; multiple sclerosis; neuroimaging; neuropsychology; patient oriented research; quality of life; stress management

DESCRIPTION (provided by applicant): MS is a frequently disabling autoimmune disease affecting approximately 350,000 people in the United States. It is among the most disabling diseases in the United States, with 81% of all patients out of the workforce. More that two decades of research has consistently shown a relationship between stressful life events (SLEs), in particular non-traumatic family and work stressors, and subsequent clinical exacerbation. Furthermore, we have shown that non-traumatic SLEs increase the risk of the subsequent appearance of new gadolinium enhancing (Gd+) magnetic resonance imaging (MRI) brain lesions, an early marker of MS inflammation and blood-brain barrier (BBB' breakdown. The purpose of this study is to determine the efficacy of cognitive behavioral therapy for MS (CBT. MS), a stress management program we have developed specifically for MS, in reducing the occurrence of new brain lesions in people with relapsing-remitting multiple sclerosis (RRMS). RRMS was selected over other types, because it is the most common form of MS and it is more likely than other types to be associated with clinical exacerbation and Gd+ MRI. One hundred and twelve patients will be enrolled for 2 years. To ensure equivalent medical treatment across patients and treatment arms, all patients will receive neurological care through the University of California, San Francisco (UCSF) MS Center. Patients will be randomly assigned to either CBT-MS or treatment as usual (TAU). The stress management program will consist of 26 weekly group stress management training sessions followed by 12 monthly booster sessions to encourage maintenance of behavioral changes, Because MS exacerbation is episodic, with annual prevalence rates of .61 - 1.68, longer maintenance of behavioral changes will greatly increase the power to detect effects. Patients will be followed for 6 months following cessation of treatment and booster sessions. To encourage retention, TAU patients will be offered 26 weeks of CBT-MS after completing the study. Consistent with Phase II clinical trials in MS, the primary outcome will be Gd+ MRI brain lesions acquired at screening, and months 3, 6, 12, 18, and 24. Secondary neuroimaging outcomes will include T2-weighted MRI and brain parenchymal fraction (BPF). Secondary clinical outcomes will include MS exacerbation rate, progression of disability, and neuropsychological impairment. Quality of life will be examined as a secondary outcome to evaluate clinical utility. We also wilt enhance our understanding of mechanisms by examining potential psychosocial, immune, and endocrine mediators of the relationship betweenSLEs and clinical and neuroimaging markers of MS inflammation.

描述（由申请人提供）：MS 是一种经常致残的自身免疫性疾病，影响着美国约 350,000 人。它是美国最致残的疾病之一，81% 的患者失去了劳动力。二十多年的研究一致表明，压力生活事件（SLE），特别是非创伤性家庭和工作压力源，与随后的临床恶化之间存在关系。此外，我们还发现，非创伤性 SLE 会增加随后出现新的钆增强 (Gd+) 磁共振成像 (MRI) 脑损伤的风险，这是多发性硬化症炎症和血脑屏障 (BBB' 破坏) 的早期标志。本研究的目的是确定多发性硬化症认知行为疗法 (CBT. MS) 的功效，这是我们专门针对多发性硬化症开发的压力管理计划，可减少复发缓解型多发性硬化症患者新脑损伤的发生选择 RRMS 而非其他类型，因为它是最常见的 MS 形式，并且比其他类型更有可能与临床恶化相关，并且将招募 112 名患者为期 2 年。为了确保患者和治疗组之间获得同等的医疗服务，所有患者都将通过加州大学旧金山分校 (UCSF) MS 中心接受神经科护理，患者将被随机分配接受 CBT-MS 或照常治疗 (TAU)。压力管理计划将包括 26 周一次的团体压力管理培训课程，随后是 12 个月的强化课程，以鼓励维持行为改变。由于 MS 恶化是偶发性的，年患病率为 0.61 - 1.68，因此更长时间地维持行为改变将大大提高治疗效果。增加检测效果的能力。停止治疗和加强治疗后，将对患者进行 6 个月的随访。为了鼓励保留，TAU 患者将在完成研究后接受 26 周的 CBT-MS。与 MS 的 II 期临床试验一致，主要结果将是筛查时以及第 3、6、12、18 和 24 个月时获得的 Gd+ MRI 脑损伤。次要神经影像结果将包括 T2 加权 MRI 和脑实质分数 (BPF) ）。次要临床结局包括 MS 恶化率、残疾进展和神经心理损伤。生活质量将作为评估临床效用的次要结果进行检查。我们还将通过检查 SLE 与多发性硬化症炎症的临床和神经影像标志物之间关系的潜在心理社会、免疫和内分泌介质来增强我们对机制的理解。