通过扩散张量成像评估认知行为疗法对强迫症患者白质纤维的影响:平行组对照试验研究方案

Xiang-yun Yang, Jia Luo, Jing Liu, Yun Ma, Zhi-hua Guo, Xiao-jie Yang, Zhanjiang Li
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引用次数: 3

摘要

背景:短时认知行为疗法是治疗强迫症的有效方法。它会改变多个大脑区域或组织的功能,并改善症状。影像研究显示强迫症患者的白质纤维束微结构发生变化。方法/设计:我们将在中国首都医科大学北京安定医院进行单盲、平行、对照试验。60名强迫症患者将接受为期12周的认知行为治疗。另外60名健康对照者将构成对照组。所有参与者将在12周治疗前后进行评估。主要结果将是通过扩散张量成像评估额-纹状体-丘脑回路的分数各向异性值。次要结果为耶鲁-布朗强迫症量表、汉密尔顿抑郁评定量表和汉密尔顿焦虑量表得分。讨论:本试验将评估使用弥散张量成像的认知行为疗法治疗强迫症患者后白质纤维的变化。这将有望揭示认知行为疗法治疗强迫症的神经机制。它还将为其有效性提供客观的临床证据,并为制定个人治疗策略提供依据。试验注册:该试验于2014年10月29日在中国临床试验注册中心(http://www.chictr.org.cn/)注册(ChiCTR-IOR-14005436)。伦理:研究方案于2013年6月17日获得中国首都医科大学北京安定医院伦理委员会批准,批准文号(2013)Keyan(7)。知情同意书:由参与者及其监护人提供书面知情同意书。
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Effects of cognitive behavioral therapy on white matter fibers of patients with obsessive-compulsive disorder as assessed by diffusion tensor imaging: study protocol for a parallel group, controlled trial
Background: Short-duration cognitive behavioral therapy is an effective method for the treatment of obsessive-compulsive disorder. It alters the functions of multiple brain regions or tissues, and improves symptoms. Imaging studies show changes in the microstructure of white matter fiber bundles of patients with obsessive-compulsive disorder. Methods/Design: We will conduct a single-blind, parallel, controlled trial in the Beijing Anding Hospital, Capital Medical University, China. A cohort of 60 patients with obsessive-compulsive disorder will undergo 12 weeks of cognitive behavioral therapy. An additional 60 healthy controls will comprise the control group. All participants will be evaluated before and after 12 weeks of treatment. The primary outcome will be fractional anisotropy values in the frontal-striatal-thalamic circuits assessed by diffusion tensor imaging. The secondary outcomes will be Yale-Brown Obsessive-Compulsive Scale, Hamilton Depression Rating Scale, and Hamilton Anxiety Scale scores. Discussion: This trial will assess the changes in white matter fibers of patients with obsessive-compulsive disorder after treatment with cognitive behavioral therapy using diffusion tensor imaging. This will hopefully reveal the neural mechanisms underlying the treatment of obsessive-compulsive disorder by cognitive behavioral therapy. It will also provide objective clinical evidence of its effectiveness, and for the development of individual treatment strategies. Trial registration: This trial was registered with the Chinese Clinical Trial Registry (http://www.chictr.org.cn/) (ChiCTR-IOR-14005436) on 29 October 2014. Ethics: The study protocol was approved by the Ethics Committee of Beijing Anding Hospital of Capital Medical University of China on 17 June 2013, approval number (2013)Keyan(7). Informed consent: Written informed consent will be provided by participants and their guardians.
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