A double-blind, randomized, placebo-controlled trial of a computer-based Interpretation Bias Training for youth with severe irritability: a study protocol.

A double-blind, randomized, placebo-controlled trial of a computer-based Interpretation Bias Training for youth with severe irritability: a study protocol.
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DOI:
10.1186/s13063-018-2960-5
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发表时间:
2018-11-14
期刊:
影响因子:
2.5
通讯作者:
Brotman MA
Brotman MA
中科院分区:
医学4区
文献类型:
--
作者:
Haller SP;Stoddard J;MacGillivray C;Stiles K;Perhamus G;Penton-Voak IS;Bar-Haim Y;Munafò MR;Brotman MA

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严重的、慢性的、损害性的易怒是青少年常见的临床问题。事实上,它最近在DSM-5中被定义为破坏性情绪失调障碍(DMDD)。然而,到目前为止,还没有专门针对重度抑郁症开发的循证治疗方法。目前的随机对照试验评估了基于计算机的认知训练干预(解释偏差训练;IBT)在青年DMDD患者中的疗效。IBT的目的是通过电脑反馈改变对模糊面部情绪的判断,从而减少烦躁。IBT是基于先前的发现,即患有易怒相关精神病理的年轻人认为模棱两可的面孔更具敌意和恐惧感。这是一项双盲,随机对照试验IBT在40青年DMDD。参与者将在4天内随机接受4次IBT训练(积极训练和虚假训练)。主动IBT提供计算机反馈,将模棱两可的面部表情解释转变为快乐的解释。分别在训练前、训练后和训练后2周进行面部情绪判断。盲法临床医生将进行每周临床评分。主要结果测量使用临床评定的情感反应指数(ARI)和临床总体印象改善(CGI-I)量表评估DMDD的易怒变化,以及使用ARI的父母和儿童易怒报告。次要结果测量包括临床医生对抑郁、焦虑和整体损害的评分。此外,还将收集父母和儿童的抑郁、焦虑、愤怒、社会地位和攻击行为的自我报告。本方案中描述的研究将首次进行随机对照试验,测试IBT在减少DMDD青年患者易怒方面的疗效。为患有严重慢性易怒的青少年开发非药物治疗方案对于潜在地增强现有治疗非常重要。ClinicalTrials.gov, ID: NCT02531893。于2015年8月25日注册。本文的在线版本(10.1186/s13063-018-2960-5)包含补充资料,仅供授权用户使用。
Severe, chronic, and impairing irritability is a common presenting clinical problem in youth. Indeed, it was recently operationalized as disruptive mood dysregulation disorder (DMDD) in the DSM-5. However, to date, there are no evidence-based treatments that were specifically developed for DMDD. The current randomized controlled trial assesses the efficacy of a computer-based cognitive training intervention (Interpretation Bias Training; IBT) in youth with DMDD. IBT aims to reduce irritability by altering judgments of ambiguous face-emotions through computerized feedback. IBT is based on previous findings that youth with irritability-related psychopathology rate ambiguous faces as more hostile and fear producing. This is a double-blind, randomized controlled trial of IBT in 40 youth with DMDD. Participants will be randomized to receive four IBT sessions (Active vs. Sham training) over 4 days. Active IBT provides computerized feedback to change ambiguous face-emotion interpretations towards happy interpretations. Face-emotion judgments are performed pre and post training, and for 2 weeks following training. Blinded clinicians will conduct weekly clinical ratings. Primary outcome measures assess changes in irritability using the clinician-rated Affective Reactivity Index (ARI) and Clinical Global Impressions-Improvement (CGI-I) scale for DMDD, as well as parent and child reports of irritability using the ARI. Secondary outcome measures include clinician ratings of depression, anxiety, and overall impairment. In addition, parent and child self-report measures of depression, anxiety, anger, social status, and aggression will be collected. The study described in this protocol will perform the first RCT testing the efficacy of IBT in reducing irritability in youth with DMDD. Developing non-pharmacological treatment options for youth suffering from severe, chronic irritability is important to potentially augment existing treatments. ClinicalTrials.gov, ID: NCT02531893. Registered on 25 August 2015. The online version of this article (10.1186/s13063-018-2960-5) contains supplementary material, which is available to authorized users.
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