An iPad application-based intervention for improving post-stroke depression symptoms in a convalescent rehabilitation ward: A pilot randomized controlled clinical trial protocol
An iPad application-based intervention for improving post-stroke depression symptoms in a convalescent rehabilitation ward: A pilot randomized controlled clinical trial protocol
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DOI：
10.1016/j.invent.2020.100340
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发表时间：
2020-08
期刊：
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通讯作者：
Hiroyuki Uchida;Yoshiya Hiragaki;Yuta Nishi;Shiori Nakahara;Junki Koumoto;Yusuke Onmyoji;Norimasa Fujimoto;Kazuho Kawakami;Masato Ishii;Kazuki Hirao
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作者：
Hiroyuki Uchida;Yoshiya Hiragaki;Yuta Nishi;Shiori Nakahara;Junki Koumoto;Yusuke Onmyoji;Norimasa Fujimoto;Kazuho Kawakami;Masato Ishii;Kazuki Hirao
脑卒中后抑郁（PSD）是一种神经精神疾病的后遗症，对脑卒中患者的预后有严重的不良影响。我们开发的iPad应用程序是一种非常创新的方法，旨在通过在视频中呈现积极的单词刺激来改善参与者的抑郁症状。虽然这种应用比现有的药物和非药物干预具有更少的副作用，并且可能减轻患者和护理人员的负担，但其对PSD的疗效尚未研究。在这里，我们提出了一项试点随机对照试验（RCT）方案，以研究这种应用干预对PSD患者的治疗潜力。方法本研究设计为5周、单中心、开放标签、平行组、先导随机对照试验。32例PSD患者将被随机分配到iPad应用程序与常规康复或单独常规康复的组合（1:1分配比例）。iPad应用干预每天持续3分钟，常规康复每天持续3小时。主要结果是在5周干预结束时，流行病学研究中心抑郁量表评分从基线的变化。本试验RCT是首个探讨iPad应用干预减轻PSD患者抑郁症状的潜力的研究。该试验RCT确定了这是否是一种可行和有效的干预措施，并为全面试验的设计提供信息。如果我们的假设是正确的，本试验可以为增强iPad应用干预的标准实践提供证据，以改善PSD患者的抑郁症状。
BackgroundPost-stroke depression (PSD) is a neuropsychiatric sequela that causes serious adverse effects on the prognosis of stroke patients. Our developed iPad application is a very innovative approach designed to improve participants' depressive symptoms by presenting positive words stimuli in a video. Although this application has fewer side effects than existing pharmacological and non-pharmacological interventions and is likely less burdensome for patients and caregivers, its efficacy for PSD has not been investigated. Here we present a pilot randomized controlled trial (RCT) protocol to investigate the therapeutic potential of this application intervention for PSD patients.MethodsThis study is designed as a 5-week, single-center, open-label, parallel-group, pilot RCT. Thirty-two patients with PSD will be randomly assigned to a combination of the iPad application and usual rehabilitation or usual rehabilitation alone (1:1 allocation ratio). The iPad application intervention lasts 3 min a day, and the usual rehabilitation lasts 3 h a day. The primary outcome is the change from baseline in The Center for Epidemiologic Studies Depression Scale score at the end of the 5-week intervention.DiscussionThis pilot RCT is the first study to investigate the potential of iPad application interventions to reduce depressive symptoms in PSD patients. This pilot RCT determines whether this is a viable and effective intervention and informs the design for a full-scale trial. If our hypothesis is correct, this trial can provide evidence to augment the standard practice of iPad application interventions to improve depressive symptoms in patients with PSD.