Introduction: Mindfulness-based interventions have been studied as an alternative treatment for anxiety disorders, but there are only a few studies comparing these with established treatments. Objective: To evaluate the efficacy of a Body in Mind Training (BMT) program for adults with generalized anxiety disorder (GAD), an active comparison protocol called Quality of Life and Psychoeducation (QoL), and treatment with fluoxetine (FLX). Methods: This study comprises a 3-arm parallel-group, randomized clinical trial (ClinicalTrials.gov ID: NCT03072264). Adults with a primary diagnosis of GAD and no current treatment were recruited from the community and randomized in a ratio 1:1:1. The primary outcomes were assessed by means of the Hamilton Anxiety Rating Scale (HAM-A) and the Penn State Worry Questionnaire (PSWQ) at week 8. Data were analyzed using a superiority analysis (BMT vs. QoL) and a noninferiority analysis (BMT vs. FLX). Results: A total of 249 participants were included and 223 were analyzed (76 BMT, 79 FLX, and 68 QoL). All groups improved after intervention. However, BMT was not superior to QoL at week 8 (mean difference = –1.36; p = 0.47), nor was it noninferior to FLX as assessed with theHAM-A (mean difference = 3.5; 95% CI –0.06 to 7.06; noninferiority margin = –2.43; p = 0.054). QoL (mean difference = 3.54; p = 0.04) and FLX (mean difference = –7.72; 95% CI –10.89 to –4.56; noninferiority margin = –2.09; p #x3c; 0.001) were superior to BMT in reducing PSWQ score. Conclusion: Our data suggest that BMT, in its current format, cannot be considered an effective mindfulness protocol to improve GAD.
Psychother Psychosom

中文翻译：

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一项三臂随机临床试验，比较基于正念的干预与积极对照组和氟西汀治疗成人广泛性焦虑症的疗效

简介：基于正念的干预措施已被研究作为焦虑症的替代治疗方法，但只有少数研究将这些方法与既定的治疗方法进行比较。目标：评估身心训练 (BMT) 计划对患有广泛性焦虑症 (GAD) 的成年人、称为生活质量和心理教育 (QoL) 的主动比较方案以及氟西汀 (FLX) 治疗的功效。方法：本研究包括一项 3 臂平行组随机临床试验（ClinicalTrials.gov ID：NCT03072264）。从社区招募初步诊断为 GAD 且目前未接受治疗的成年人，并以 1:1:1 的比例随机分配。在第 8 周时通过汉密尔顿焦虑评定量表 (HAM-A) 和宾夕法尼亚州立大学担忧问卷 (PSWQ) 评估主要结果。使用优势分析（BMT 与 QoL）和非劣效分析（BMT）分析数据与 FLX 相比）。结果：共纳入 249 名参与者，分析了 223 名参与者（76 名 BMT、79 名 FLX 和 68 名 QoL）。所有组在干预后都有所改善。然而，第 8 周 BMT 并不优于 QoL（平均差异 = –1.36；p= 0.47），也不劣于使用 HAM-A 评估的 FLX（平均差异 = 3.5；95% CI –0.06 至 7.06；非劣效性界限 = –2.43；p = 0.054）。QoL（平均差 = 3.54；p = 0.04）和 FLX（平均差 = –7.72；95% CI –10.89 至 –4.56；非劣效边际 = –2.09；p #x3c；0.001）在降低 PSWQ 评分方面优于 BMT。结论：我们的数据表明，目前的 BMT 不能被视为改善 GAD 的有效正念方案。
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