智能手机传递的积极词汇刺激对亚阈值抑郁症患者抑郁情绪的影响：一项试点随机对照试验方案
Effects of Smartphone-Delivered Positive-Word Stimulation on Depressed Mood in People with Subthreshold Depression: Protocol for a Pilot Randomized Controlled Trial.
作者信息
Ejiri Hitomi, Uchida Hiroyuki, Tsuchiya Kenji, Fujiwara Kazuhiko, Kikuchi Senichiro, Hirao Kazuki
机构信息
School of Health Sciences, Faculty of Medicine, Gunma University, Maebashi, Japan.
Department of Rehabilitation, Kurashiki Heisei Hospital, Kurashiki, Japan.
出版信息
Neuropsychiatr Dis Treat. 2021 Aug 20;17:2739-2748. doi: 10.2147/NDT.S323126. eCollection 2021.
BACKGROUND
Major depressive disorder (MDD) is an important public health problem. Thus, preventive interventions against subthreshold depression (StD), which is one of the key risk factors for the development of MDD, are important. The study developed a smartphone application (SPSRS) that improves depressive symptoms in people with StD by automatically presenting positive word stimuli during videos. The SPSRS application has the potential to improve depressive symptoms in people with StDs. However, whether it can immediately improve depressed moods in people with StD is unclear. The study presents a protocol for investigating the immediate effects of the SPSRS application intervention on depressed mood in people with StD.
METHODS
The study is designed as an open-label, parallel-group, and pilot randomized controlled trial (RCT). Thirty-two people who meet the criteria for StD (Beck Depression Inventory-II score of 10 points or more and fails to meet the diagnostic criteria for MDD) will be recruited and studied. It compares the immediate effects of the SPSRS application intervention (with positive word stimulus in a 10-minute video; n = 16) and YouTube application intervention (without positive word stimulus in 10-minute video; n = 16). The primary outcome is the change in the score for the Profile of Mood States 2nd Edition-Adult Short after 10 minutes of intervention. The secondary outcome is the change in the State-Trait Anxiety Inventory State after 10 min of intervention.
DISCUSSION
The pilot RCT is the first to evaluate the immediate effects of the SPSRS application intervention on depressed mood in people with StD. The results are expected to provide a preliminary outcome of the immediate effect of the SPSRS application on the depressed mood of people with StD and aid in planning a full-scale trial.
TRIAL REGISTRATION
ClinicalTrials.gov; Identifier: NCT03864484.
背景
重度抑郁症（MDD）是一个重要的公共卫生问题。因此，针对阈下抑郁（StD）的预防性干预措施很重要，因为StD是MDD发生的关键风险因素之一。该研究开发了一款智能手机应用程序（SPSRS），通过在视频中自动呈现积极词汇刺激来改善StD患者的抑郁症状。SPSRS应用程序有改善StD患者抑郁症状的潜力。然而，它是否能立即改善StD患者的抑郁情绪尚不清楚。该研究提出了一项方案，以调查SPSRS应用程序干预对StD患者抑郁情绪的即时影响。
方法
该研究设计为开放标签、平行组、试点随机对照试验（RCT）。将招募32名符合StD标准（贝克抑郁量表-II得分10分或更高且未达到MDD诊断标准）的人进行研究。它比较了SPSRS应用程序干预（在10分钟视频中有积极词汇刺激；n = 16）和YouTube应用程序干预（在10分钟视频中无积极词汇刺激；n = 16）的即时效果。主要结局是干预10分钟后成人简版情绪状态量表第二版得分的变化。次要结局是干预10分钟后状态-特质焦虑量表状态分量表得分的变化。
讨论
该试点RCT首次评估了SPSRS应用程序干预对StD患者抑郁情绪的即时影响。预期结果将提供SPSRS应用程序对StD患者抑郁情绪即时影响的初步结果，并有助于规划全面试验。
试验注册
ClinicalTrials.gov；标识符：NCT03864484。
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