Clinical Efficacy and Psychological Mechanisms of an App-Based Digital Therapeutic for Generalized Anxiety Disorder: Randomized Controlled Trial.
Clinical Efficacy and Psychological Mechanisms of an App-Based Digital Therapeutic for Generalized Anxiety Disorder: Randomized Controlled Trial.
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一款基于应用程序的广泛性焦虑障碍数字疗法的临床疗效及心理作用机制：随机对照试验
DOI：
10.2196/26987
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发表时间：
2021-12-02
影响因子：
7.4
通讯作者：
Brewer JA
中科院分区：
文献类型：
--
作者：
Roy A;Hoge EA;Abrante P;Druker S;Liu T;Brewer JA
目前针对广泛性焦虑障碍（GAD）的治疗往往效果欠佳，部分原因是对潜在心理机制（如回避强化学习）的针对性不足。正念训练（MT）已显示出对焦虑有治疗效果；然而，其广泛应用受到限制，部分原因是难以扩大基于面对面的实施规模。数字疗法正逐渐成为潜在可行的治疗方法；然而，经过实证验证的却极少。
本研究旨在测试一款应用程序提供的正念训练的疗效和作用机制。该训练旨在针对焦虑的一种潜在机制（强化学习），此前的研究已对反馈以及通过负强化使焦虑持续存在的问题表示关注。
研究通过社交媒体广告招募广泛性焦虑障碍患者，并在其进行面对面问诊时将他们随机分组，一组接受常规治疗（n = 33），另一组接受常规治疗加应用程序提供的正念训练（“舒缓焦虑”应用程序；n = 32）。后者包含30个模块，需在两个月内完成。在治疗开始1个月和2个月后，使用自我报告问卷评估相关的结果变化。
在本研究中，我们将65名参与者随机分组，并采用改良的意向性分析方法进行分析。正念训练组完成的模块中位数为30个中的25.5个（四分位间距为17）；46%（13/28）的参与者完成了该项目。此外，与对照组相比，正念训练组在2个月时焦虑（采用广泛性焦虑障碍量表7项版，GAD - 7评估）显著减轻（67% 对 14%；GAD - 7的中位数变化：–8.5 [四分位间距6.5] 对 –1.0 [四分位间距5.0]；P <.001；95% 置信区间为6 - 10）。1个月时正念（无反应性子量表）的提升介导了2个月时担忧情绪（采用宾夕法尼亚州立大学担忧问卷评估）的减轻（P = 0.02），1个月时担忧情绪的减轻又介导了2个月时焦虑的减轻（P = 0.03）。
据我们所知，这是首篇关于应用程序提供的正念训练对广泛性焦虑障碍的疗效和作用机制的报告。这些研究结果证明了正念训练作为针对焦虑个体的数字疗法的临床疗效（需治疗人数 = 1.6）。这些结果还将我们对焦虑作用机制的最新认识与治疗发展联系起来，表明应用程序提供的正念训练针对关键的强化学习途径，从而切实、在临床上显著减轻了担忧和焦虑。基于证据、针对作用机制的数字疗法有潜力以低成本改善人群的健康状况。
临床试验注册号：ClinicalTrials.gov NCT03683472；https://clinicaltrials.gov/ct2/show/NCT03683472
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
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影响因子：
34.7
作者：
Arnsten, Amy F. T.
通讯作者：
Arnsten, Amy F. T.
DOI：
10.1037/hea0000874
发表时间：
2020-09
期刊：
Health psychology : official journal of the Division of Health Psychology, American Psychological Association
影响因子：
--
作者：
Brewer JA;Roy A;Deluty A;Liu T;Hoge EA
通讯作者：
Hoge EA
影响因子：
2.9
作者：
Brewer, Judson A.;Garrison, Kathleen A.;Whitfield-Gabrieli, Susan
通讯作者：
Whitfield-Gabrieli, Susan
影响因子：
4.1
作者：
Ali, Shehzad;Rhodes, Laura;Delgadillo, Jaime
通讯作者：
Delgadillo, Jaime
影响因子：
2.8
作者：
Borkovec, TD;Ray, WJ;Stöber, J
通讯作者：
Stöber, J