自导数字行为疗法与纤维肌痛主动对照 (PROSPER-FM):一个第三阶段的多中心随机对照试验
R Michael Gendreau1, Lance M McCracken2, David A Williams3
1Gendreau Consulting, Poway, CA, USA.
Lancet (London, England)
|July 11, 2024
概括
一个为期12周的数字接受和承诺治疗 (ACT) 计划改善了纤维肌痛治疗. 这种通过智能手机进行的自我指导干预在成年患者中显示出显著的疗效和安全性.
科学领域:
- 数字卫生干预措施
- 行为医学
- 治疗慢性疼痛
背景情况:
- 纤维肌痛管理指南建议认知行为疗法如接受和承诺疗法 (ACT).
- 现有的ACT项目往往是患者无法使用的.
- 需要为纤维肌痛提供可访问的数字干预措施.
研究的目的:
- 通过智能手机提供12周的数字ACT程序的有效性.
- 评估数字ACT对纤维肌痛治疗的影响.
- 确定这种数字干预的安全性和有效性.
主要方法:
- 一项随机临床试验 (PROSPER- FM) 涉及275名成年纤维肌痛患者.
- 参与者被分配到数字ACT组或活跃对照组 (症状跟踪和教育材料).
- 主要终点是患者在12周的总体印象变化 (PGIC),根据治疗意图进行分析.
主要成果:
- 在数字ACT组中,71%的参与者在12周后报告了PGIC的改善,而在活跃对照组中为22%.
- 这代表了改善比例的显著差异 (48.4%,p<0.0001).
- 在试验期间没有报告与设备相关的安全事件.
结论:
- 智能手机提供的数字ACT是一种安全有效的治疗成年人纤维肌痛的方法.
- 这种数字化方法为传统的ACT课程提供了更容易获得的替代方案.
- 数字ACT有望改善患者报告的纤维肌痛结局.
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