Iacoviello Brian M, Murrough James W, Hoch Megan M, Huryk Kathryn M, Collins Katherine A, Cutter Gary R, Iosifescu Dan V, Charney Dennis S
Click Therapeutics, Inc., New York, NY, USA.
Department of Psychiatry, Mood and Anxiety Disorders Program, Icahn School of Medicine at Mount Sinai, New York, NY, USA.
NPJ Digit Med. 2018;1. doi: 10.1038/s41746-018-0025-5. Epub 2018 Jun 6.
There is an urgent need for more effective treatments for major depressive disorder (MDD). Digital therapeutics, such as computerized cognitive-emotional training interventions, represent a promising new strategy for treating MDD. Here we report a replication of efficacy of a digital cognitive-emotional training intervention designed to enhance cognitive control for emotional information-processing. In a randomized, double-blind, controlled study design, fifty-one participants with MDD in a current major depressive episode were randomly assigned to participate in a digital cognitive-emotional training regimen (Emotional Faces Memory Task (EFMT); n= 28) involving 18 sessions over 6 weeks, or an active control condition (CT; n= 23) involving computerized working memory training. MDD symptoms were assessed weekly using a clinician-rated measure (Hamilton Depression Rating Scale; Ham-D); and neurocognition (working memory), at baseline and study outcome. Mixed-effects model for repeated measures (MMRM) analysis of all participants randomized revealed a significantly greater reduction in MDD symptom severity (Ham-D) from baseline to outcome in the EFMT group (8.65 points) compared to the CT group (4.77 points) ((6,205)= 3.23, = .005, = .46). Ten of 28 EFMT participants achieved clinical response (≥ 50% reduction in symptoms) compared to 4 of 23 in CT. Both groups exhibited similar, small improvements in working memory. This replicated the preliminary efficacy of a digital cognitive-emotional training approach for the treatment of MDD. EFMT may be a feasible and effective intervention strategy for MDD, but future studies to elucidate its mechanism of action are warranted. This study is registered with Clinicaltrials.gov (NCT: 01934491).
对于重度抑郁症（MDD），迫切需要更有效的治疗方法。数字疗法，如计算机化认知 - 情感训练干预，是一种有前景的治疗MDD的新策略。在此，我们报告了一种旨在增强对情绪信息处理的认知控制的数字认知 - 情感训练干预的疗效复制情况。在一项随机、双盲、对照研究设计中，51名处于当前重度抑郁发作期的MDD患者被随机分配，参与一项为期6周、共18节课程的数字认知 - 情感训练方案（情绪面孔记忆任务（EFMT）；n = 28），或参与一项涉及计算机化工作记忆训练的积极对照条件（CT；n = 23）。每周使用临床医生评定量表（汉密尔顿抑郁评定量表；Ham - D）评估MDD症状；并在基线和研究结果时评估神经认知（工作记忆）。对所有随机分组的参与者进行重复测量的混合效应模型（MMRM）分析显示，与CT组（4.77分）相比，EFMT组从基线到结果的MDD症状严重程度（Ham - D）显著降低更多（8.65分）（（6,205）= 3.23， = .005， = .46）。28名EFMT参与者中有10人实现了临床缓解（症状减轻≥50%），而CT组23人中有4人实现临床缓解。两组在工作记忆方面均有类似的小幅度改善。这复制了数字认知 - 情感训练方法治疗MDD的初步疗效。EFMT可能是一种治疗MDD的可行且有效的干预策略，但有必要开展进一步研究以阐明其作用机制。本研究已在Clinicaltrials.gov注册（NCT：01934491）。
