Background and Purpose:Disabling anxiety affects a quarter of stroke survivors but access to treatment is poor. We developed a telemedicine model for delivering guided self-help cognitive behavioral therapy (CBT) for anxiety after stroke (TASK-CBT). We aimed to evaluate the feasibility of TASK-CBT in a randomized controlled trial workflow that enabled all trial procedures to be carried out remotely. In addition, we explored the feasibility of wrist-worn actigraphy sensor as a way of measuring objective outcomes in this clinical trial.Methods:We recruited adult community-based stroke patients (n=27) and randomly allocated them to TASK-CBT (n=14) or relaxation therapy (TASK-Relax), an active comparator (n=13).Results:In our sample (mean age 65 [±10]; 56% men; 63% stroke, 37% transient ischemic attacks), remote self-enrolment, electronic signature, intervention delivery, and automated follow-up were feasible. All participants completed all TASK-CBT sessions (14/14). Lower levels of anxiety were observed in TASK-CBT when compared with TASK-Relax at both weeks 6 and 20. Mean actigraphy sensor wearing-time was 33 days (±15).Conclusions:Our preliminary feasibility data from the current study support a larger definitive clinical trial and the use of wrist-worn actigraphy sensor in anxious stroke survivors.Registration:URL: https://www.clinicaltrials.gov. Unique identifier: NCT03439813.

中文翻译：

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中风后焦虑的远程医疗认知行为疗法：概念验证随机对照试验。

背景和目的：致残性焦虑影响了四分之一的中风幸存者，但获得治疗的机会很差。我们开发了一种远程医疗模型，用于为中风后焦虑症 (TASK-CBT) 提供引导式自助认知行为疗法 (CBT)。我们旨在评估 TASK-CBT 在随机对照试验工作流程中的可行性，该工作流程使所有试验程序都可以远程执行。此外，我们探讨了将腕戴式活动记录传感器作为衡量本临床试验客观结果的一种方法的可行性。方法：我们招募了成年社区卒中患者（n=27）并将他们随机分配到 TASK-CBT（n =14) 或放松疗法 (TASK-Relax)，一种主动比较 (n=13)。结果：在我们的样本中（平均年龄 65 [±10]；56% 男性；63% 中风，37% 短暂性脑缺血发作），远程自助注册、电子签名、干预交付和自动跟进是可行的。所有参与者都完成了所有 TASK-CBT 会话 (14/14)。在第 6 周和第 20 周，与 TASK-Relax 相比，TASK-CBT 的焦虑程度较低。运动记录传感器的平均佩戴时间为 33 天 (±15)。结论：我们目前研究的初步可行性数据支持更大的最终临床试验和在焦虑中风幸存者中使用腕戴式活动记录仪。注册：URL：https://www.clinicaltrials.gov。唯一标识符：NCT03439813。我们目前研究的初步可行性数据支持更大规模的确定性临床试验以及在焦虑的中风幸存者中使用腕戴式活动记录传感器。注册：URL：https://www.clinicaltrials.gov。唯一标识符：NCT03439813。我们目前研究的初步可行性数据支持更大规模的确定性临床试验以及在焦虑的中风幸存者中使用腕戴式活动记录传感器。注册：URL：https://www.clinicaltrials.gov。唯一标识符：NCT03439813。