Supplementary Material for: A Three-Arm Randomized Clinical Trial Comparing the Efficacy of a Mindfulness-Based Intervention with an Active Comparison Group and Fluoxetine Treatment for Adults with Generalized Anxiety Disorder

<b><i>Introduction:</i></b> 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. <b><i>Objective:</i></b> 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). <b><i>Methods:</i></b> 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). <b><i>Results:</i></b> 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; <i>p</i> = 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; <i>p</i> = 0.054). QoL (mean difference = 3.54; <i>p</i> = 0.04) and FLX (mean difference = –7.72; 95% CI –10.89 to –4.56; noninferiority margin = –2.09; <i>p</i> &lt; 0.001) were superior to BMT in reducing PSWQ score. <b><i>Conclusion:</i></b> Our data suggest that BMT, in its current format, cannot be considered an effective mindfulness protocol to improve GAD.

**引言**：基于正念的干预手段已被探索为焦虑障碍的替代治疗方案，但目前仅有少量研究将其与已确立的主流疗法进行对照比较。
**目的**：评估「身心训练（Body in Mind Training, BMT）」方案对成人广泛性焦虑障碍（Generalized Anxiety Disorder, GAD）的疗效，并设置活性对照方案「生活质量与心理教育（Quality of Life and Psychoeducation, QoL）」以及氟西汀（fluoxetine, FLX）药物治疗作为对照。
**方法**：本研究为一项三臂平行分组随机临床试验（ClinicalTrials.gov 注册号：NCT03072264）。从社区招募主要诊断为GAD且当前未接受任何治疗的成人受试者，以1:1:1的比例随机分组。主要结局指标于第8周通过汉密尔顿焦虑量表（Hamilton Anxiety Rating Scale, HAM-A）与宾州忧虑问卷（Penn State Worry Questionnaire, PSWQ）进行评估。数据分析采用优效性分析（BMT vs QoL）与非劣效性分析（BMT vs FLX）两种方法。
**结果**：共计纳入249名受试者，最终完成分析的共223例（BMT组76例、FLX组79例、QoL组68例）。所有组别在干预后均出现症状改善。然而，第8周评估结果显示，BMT并未展现出优于QoL的疗效（均数差=–1.36；*p*=0.47）；以HAM-A量表评估时，BMT亦未达到非劣效于FLX的标准（均数差=3.5；95%置信区间：–0.06至7.06；非劣效界值=–2.43；*p*=0.054）。在降低PSWQ评分方面，QoL组（均数差=3.54；*p*=0.04）与FLX组（均数差=–7.72；95%置信区间：–10.89至–4.56；非劣效界值=–2.09；*p*<0.001）均显著优于BMT组。
**结论**：本研究数据表明，现有实施形式下的BMT不能被视为改善广泛性焦虑障碍的有效正念干预方案。