对于患有强迫症障碍的成年人进行为期4天的强化与标准认知行为疗法的单盲,并行组,随机,受控非劣势试验的研究方案
Ekaterina Ivanova1, Robin Fondberg2, Oskar Flygare3
1Centre for Psychiatry Research, Department of Clinical Neuroscience, Karolinska Institutet & Stockholm Health Care Services, Stockholm, Sweden ekaterina.ivanova@ki.se.
BMJ open
|December 15, 2023
概括
对强迫症 (OCD) 进行新的4天组治疗 (B4DT) 可能与传统的个人治疗一样有效. 本研究将B4DT与黄金标准CBT进行比较,以确定其非劣势性.
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
- 心理健康治疗 心理健康治疗
背景情况:
- 个人认知行为疗法 (CBT) 与暴露和响应预防是强迫症 (OCD) 的有效治疗方法.
- 个人CBT是资源密集型,需要3-4个月的每周会议.
- 一种新的4天强化小组形式,贝根4天治疗 (B4DT),已经显示出希望,但需要严格的评估.
研究的目的:
- 为了比较伯根4天治疗 (B4DT) 与强迫症个人CBT的疗效.
- 确定B4DT是否与目前强迫症治疗的黄金标准治疗相比不劣.
- 评估二次结果,包括成本效益和治疗反应率.
主要方法:
- 一个单盲,随机对照试验,比较B4DT与个人CBT.
- 120名强迫症患者将随机分配到两个组 (60个手臂).
- 主要的结局指标是耶鲁-布朗强迫症强迫性尺度 (Y-BOCS),治疗后15周被盲目评分员评估.
主要成果:
- 该研究假设B4DT将与个人CBT相比不劣,在Y-BOCS上非劣势率为四点.
- 二次结果包括响应时间,成本效益,缓解率和不良事件.
- 所有的分析都是预先规定的,分析代码是在数据收集之前发布的.
结论:
- 这项试验将提供关键数据,说明强化B4DT对强迫症的治疗与标准的个人CBT相比并不劣.
- 研究结果将为临床实践提供有关强迫症治疗的更有效的时间和成本选择的信息.
- 该研究遵守了对非药理学试验和健康经济评估的严格报告标准.
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