翻译和文化适应在日本临床环境中治疗社会焦虑障碍的互联网认知疗法:随机对照试验的研究协议
Naoki Yoshinaga1, Graham R Thew2,3, Yuta Hayashi4
1School of Nursing, Faculty of Medicine, University of Miyazaki, 5200, Kihara, Kiyotake, Miyazaki City, 889-1692, Japan. naoki-y@med.miyazaki-u.ac.jp.
Trials
|July 19, 2024
概括
这项研究评估了日本在互联网上提供的社会焦虑障碍认知行为治疗 (iCT-SAD) 加上通常治疗 (TAU) 与单独TAU相比的有效性. 调查结果将为社会焦虑障碍的数字心理健康干预措施的全球可访问性提供信息.
科学领域:
- 精神病学是一个精神病学.
- 临床心理学 临床心理学
- 数字健康数字健康
背景情况:
- 对于社会焦虑障碍 (CT-SAD) 的认知行为疗法是基于证据的,但访问是有限的.
- 通过互联网提供的CT-SAD (iCT-SAD) 提供了一个可扩展的解决方案,显示了与面对面治疗相似的结果.
- 之前的ICT-SAD研究使用了英语程序;翻译和文化适应版本的有效性是未知的.
研究的目的:
- 为了评估日语翻译和文化调整的iCT-SAD与通常治疗 (TAU) 结合的临床疗效.
- 评估日本iCT-SAD在改善日本人口社会焦虑症状和相关结果方面的有效性.
- 探索互联网为社会焦虑障碍提供干预措施在全球范围内更广泛实施的潜力.
主要方法:
- 一个双臂,并行组,优越性随机控制试验,涉及60名患有社会焦虑障碍 (SAD) 的日本参与者.
- 参与者被随机分配 (1:1) 接受日本iCT-SAD + TAU或单独TAU.
- 主要结局指标是自我报告的利博维茨社会焦虑量表,在基线,中期治疗,治疗后和随访时进行评估.
主要成果:
- 主要分析将根据治疗意图进行,使用线性混合效应模型.
- 在iCT-SAD + TAU组和TAU单独组之间对初级和二级结果的比较.
- 评估治疗的可接受性和收集参与者的反,以告知临床效用.
结论:
- 这项试验对于理解翻译和文化适应iCT-SAD在不同文化背景中的有效性至关重要.
- 结果将为日本iCT-SAD与通常护理相结合的有效性提供有价值的见解.
- 结果将为日本在常规临床环境中iCT-SAD的潜在交付提供信息,并有助于互联网干预的全球范围.
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