Study protocol for a pilot randomized controlled trial on a smartphone application-based intervention for subthreshold depression
Study protocol for a pilot randomized controlled trial on a smartphone application-based intervention for subthreshold depression
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DOI：
10.1097/md.0000000000018934
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发表时间：
2020-01
期刊：
影响因子：
1.6
通讯作者：
Yudai Kato;Kaito Kageyama;Takanori Mesaki;Hiroyuki Uchida;Yoshiyuki Sejima;Risako Marume;Kana Takahashi;Kazuki Hirao
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文献类型：
--
作者：
Yudai Kato;Kaito Kageyama;Takanori Mesaki;Hiroyuki Uchida;Yoshiyuki Sejima;Risako Marume;Kana Takahashi;Kazuki Hirao
摘要简介：针对阈下抑郁（StD）的干预措施对于预防重度抑郁症的发生非常重要。我们的视频回放应用程序（SPSRS）旨在通过在视频中呈现积极的话语来减轻抑郁症状，为性病的治疗提供新的思路。然而，还没有随机对照试验（RCT）利用该视频回放应用程序来治疗性病患者。因此，我们设计了一个试点RCT来确定全面试验的可行性。我们在此提出了一项研究方案，用于调查视频回放应用程序对性病患者干预的效用。方法：这项为期5周的单盲、双臂、平行组、试点随机对照试验将通过比较接触过和未接触过视频回放应用程序的个体来确定视频回放应用程序的有效性。共有32名性病患者将按1:1的比例随机分为实验组和对照组。实验组将每天接受10分钟的干预，其中包含视频播放应用程序，而对照组将不接受干预。主要结果将包括5周干预后流行病学研究中心抑郁量表得分的变化，而次要结果将包括5周干预后凯斯勒心理困扰筛查量表和广泛性焦虑障碍7项量表得分的变化。统计分析使用线性混合模型与限制最大似然估计方法，然后进行。讨论：该试验RCT将首次探索SPSRS应用干预的效用，在视频中显示StD患者的积极词汇。该试验结果有望帮助设计和实施一项全面的RCT，以调查SPSRS应用对StD患者的影响。试验注册：ClinicalTrials.gov标识符：NCT04136041
Abstract Introduction: Interventions aimed at addressing subthreshold depression (StD) are important to prevent the onset of major depressive disorder. Our video playback application (SPSRS) is designed to reduce depressive symptoms by presenting positive words in videos, shedding new light on the treatment of StD. However, no randomized controlled trial (RCT) has utilized this video playback application for the treatment of individuals with StD. Therefore, a pilot RCT was designed to determine the feasibility of a full-scale trial. We herein present a study protocol for investigating the utility of a video playback application intervention for individuals with StD. Methods: This 5-week, single-blind, 2-arm, parallel-group, pilot RCT will determine the effectiveness of the video playback application by comparing individuals who had and had not been exposed to the same. A total of 32 individuals with StD will be randomly assigned to the experimental or control group at a 1:1 ratio. The experimental group will receive a 10-minute intervention containing the video playback application per day, whereas the control group will receive no intervention. The primary outcome will include changes in the Center for Epidemiologic Studies Depression Scale score after the 5-week intervention, while secondary outcomes will include changes in the Kessler Screening Scale for psychological distress and the generalized anxiety disorder 7-item scale score after the 5-week intervention. Statistical analysis using linear mixed models with the restricted maximum likelihood estimation method will then be performed. Discussion: This pilot RCT will have been the first to explore the utility of SPSRS application interventions that display positive words in videos for individuals with StD. The results of this pilot trial are expected to help in the design and implementation of a full-scale RCT that investigates the effects of SPSRS applications among individuals with StD. Trial registration: ClinicalTrials.gov Identifier: NCT04136041