Department of Behavioral and Social Sciences, Brown University School of Public Health, Providence, RI, United States.
Department of Psychiatry, Georgetown University Medical Center, Washington, DC, United States.
J Med Internet Res. 2021 Dec 2;23(12):e26987. doi: 10.2196/26987.
Current treatments for generalized anxiety disorder (GAD) often yield suboptimal outcomes, partly because of insufficient targeting of underlying psychological mechanisms (eg, avoidance reinforcement learning). Mindfulness training (MT) has shown efficacy for anxiety; yet, widespread adoption has been limited, partly because of the difficulty in scaling in-person-based delivery. Digital therapeutics are emerging as potentially viable treatments; however, very few have been empirically validated.
The aim of this study is to test the efficacy and mechanism of an app-delivered MT that was designed to target a potential mechanism of anxiety (reinforcement learning), based on which previous studies have shown concern regarding feedback and the perpetuation of anxiety through negative reinforcement.
Individuals with GAD were recruited using social media advertisements and randomized during an in-person visit to receive treatment as usual (n=33) or treatment as usual+app-delivered MT (Unwinding Anxiety; n=32). The latter was composed of 30 modules to be completed over a 2-month period. Associated changes in outcomes were assessed using self-report questionnaires 1 and 2 months after treatment initiation.
We randomized 65 participants in this study, and a modified intent-to-treat approach was used for analysis. The median number of modules completed by the MT group was 25.5 (IQR 17) out of 30; 46% (13/28) of the participants completed the program. In addition, the MT group demonstrated a significant reduction in anxiety (GAD-7) compared with the control group at 2 months (67% vs 14%; median change in GAD-7: -8.5 [IQR 6.5] vs -1.0 [IQR 5.0]; P<.001; 95% CI 6-10). Increases in mindfulness at 1 month (nonreactivity subscale) mediated decreases in worry at 2 months (Penn State Worry Questionnaire; P=.02) and decreases in worry at 1 month mediated reductions in anxiety at 2 months (P=.03).
To our knowledge, this is the first report on the efficacy and mechanism of an app-delivered MT for GAD. These findings demonstrate the clinical efficacy of MT as a digital therapeutic for individuals with anxiety (number needed to treat=1.6). These results also link recent advances in our mechanistic understanding of anxiety with treatment development, showing that app-delivered MT targets key reinforcement learning pathways, resulting in tangible, clinically meaningful reductions in worry and anxiety. Evidence-based, mechanistically targeted digital therapeutics have the potential to improve health at a population level at a low cost.
ClinicalTrials.gov NCT03683472; https://clinicaltrials.gov/ct2/show/NCT03683472.
目前针对广泛性焦虑障碍（GAD）的治疗方法往往效果不佳，部分原因是未能针对潜在的心理机制（例如回避强化学习）进行有效治疗。正念训练（MT）已被证明对焦虑有效；然而，由于难以扩大基于面对面的治疗方法，其广泛应用受到限制。数字疗法作为一种有潜力的治疗方法正在出现；然而，经过实证验证的数字疗法非常少。
本研究旨在测试一种基于应用程序的正念训练的疗效和机制，该训练旨在针对焦虑的潜在机制（强化学习），基于这一机制，之前的研究对反馈以及通过负强化持续加剧焦虑表示关注。
通过社交媒体广告招募 GAD 患者，并在现场就诊时随机分配接受常规治疗（n=33）或常规治疗+基于应用程序的 MT（Unwinding Anxiety；n=32）。后者由 30 个模块组成，需在 2 个月内完成。治疗开始后 1 和 2 个月使用自我报告问卷评估相关结果的变化。
本研究共随机入组 65 例患者，采用意向治疗法进行分析。MT 组完成的模块中位数为 30 个中的 25.5（IQR 17）个；28 例患者中的 46%（13/28）完成了整个疗程。此外，与对照组相比，MT 组在 2 个月时焦虑（GAD-7）显著降低（67% vs 14%；GAD-7 中位数变化：-8.5 [IQR 6.5] vs -1.0 [IQR 5.0]；P<.001；95%CI 6-10）。1 个月时正念的增加（非反应性亚量表）介导了 2 个月时担忧的减少（宾夕法尼亚州担忧问卷；P=.02），而 1 个月时担忧的减少介导了 2 个月时焦虑的减少（P=.03）。
据我们所知，这是第一项关于基于应用程序的 MT 治疗 GAD 的疗效和机制的报告。这些发现证明了 MT 作为焦虑个体的数字疗法的临床疗效（治疗人数=1.6）。这些结果还将我们对焦虑的机制理解的最新进展与治疗开发联系起来，表明基于应用程序的 MT 针对关键的强化学习途径，从而导致担忧和焦虑的明显、具有临床意义的减少。基于证据、针对机制的数字疗法有可能以低成本改善人群健康水平。
ClinicalTrials.gov NCT03683472；https://clinicaltrials.gov/ct2/show/NCT03683472。
