Japan Unified Protocol Clinical Trial for Depressive and Anxiety Disorders (JUNP study): study protocol for a randomized controlled trial.
Japan Unified Protocol Clinical Trial for Depressive and Anxiety Disorders (JUNP study): study protocol for a randomized controlled trial.
复制标题
日本的抑郁症和焦虑症的统一方案临床试验（JUNP研究）：随机对照试验的研究方案。
DOI：
10.1186/s12888-016-0779-8
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发表时间：
2016-03-18
期刊：
影响因子：
4.4
通讯作者：
Ono Y
中科院分区：
文献类型：
--
作者：
Ito M;Okumura Y;Horikoshi M;Kato N;Oe Y;Miyamae M;Hirabayashi N;Kanie A;Nakagawa A;Ono Y
情绪障碍跨诊断治疗的统一方案是一种很有前途的治疗方法，可以适用于广泛的精神障碍，包括抑郁症、焦虑症、创伤相关障碍和强迫症。然而，尚未进行随机对照试验来验证统一方案对患有抑郁和焦虑障碍的异质临床人群的疗效。该试验被设计为一项单中心、评估盲、随机、20周、平行组优势研究，目的是比较统一方案和常规治疗与等待名单和常规治疗相结合对抑郁症和/或焦虑症患者的疗效。主要结果是21周时的抑郁，通过17项版本的GRID-Hamilton抑郁评定量表进行评估。估计每组最小样本量为27人。我们还将研究治疗机制、治疗过程和神经心理学相关因素。本研究的结果将阐明统一方案对抑郁和焦虑障碍的疗效，以及统一方案有效性的治疗机制、过程和神经学相关因素。如果其疗效能够得到证实，对于认知行为治疗尚未被广泛采用的日本来说，统一方案可能具有很高的临床价值。ClinicalTrials.gov NCT02003261（注册于2013年12月2日）
The unified protocol for the transdiagnostic treatment of emotional disorders is a promising treatment approach that could be applicable to a broad range of mental disorders, including depressive, anxiety, trauma-related, and obsessive-compulsive disorders. However, no randomized controlled trial has been conducted to verify the efficacy of the unified protocol on the heterogeneous clinical population with depressive and anxiety disorders. The trial was designed as a single-center, assessor-blinded, randomized, 20-week, parallel-group superiority study in order to compare the efficacy of the combination of unified protocol and treatment-as-usual versus waiting-list with treatment-as-usual for patients with depressive and/or anxiety disorders. The primary outcome was depression at 21 weeks, assessed by the 17-item version of the GRID-Hamilton Rating Scale for Depression. Estimated minimum sample size was 27 participants in each group. We will also examine the treatment mechanisms, treatment processes, and neuropsychological correlates. The results of this study will clarify the efficacy of the unified protocol for depressive and anxiety disorders, and the treatment mechanism, process, and neurological correlates for the effectiveness of the unified protocol. If its efficacy can be confirmed, the unified protocol may be of high clinical value for Japan, a country in which cognitive behavioral treatment has not yet been widely adopted. ClinicalTrials.gov NCT02003261 (registered on December 2, 2013)