Objective:

The authors evaluated AKL-T03, an investigational digital intervention delivered through a video game–based interface, designed to target the fronto-parietal network to enhance functional domains for attentional control. AKL-T03 was tested in adult patients with major depressive disorder and a demonstrated cognitive impairment at baseline.

Methods:

Adults ages 25–55 years on a stable antidepressant medication regimen with residual mild to moderate depression and an objective impairment in cognition (as measured using the symbol coding test) were enrolled in a double-blind randomized controlled study. Participants were randomized either to AKL-T03 or to an expectation-matched digital control intervention. Participants were assessed at baseline and after completion of their 6-week at-home intervention. The primary outcome measure was improvement in sustained attention, as measured by the Test of Variables of Attention (TOVA).

Results:

AKL-T03 (N=37) showed a statistically significant medium-effect-size improvement in sustained attention compared with the control intervention on the TOVA primary outcome (N=37) (partial eta-squared=0.11). Additionally, a composite score derived from all cognitive measures demonstrated significant improvement with AKL-T03 over the control intervention. Individual secondary and exploratory endpoints did not demonstrate statistically significant between-group differences. No serious adverse events were reported, and two patients (5.5%) in the AKL-T03 group reported an intervention-related adverse event (headache).

Conclusions:

Treatment with AKL-T03 resulted in significant improvement in sustained attention, as well as in cognitive functioning as a whole, compared with a control intervention. AKL-T03 is a safe digital intervention that is effective in the treatment of cognitive impairment associated with major depression. Further research will be needed to understand the clinical consequences of this treatment-induced change.

中文翻译：

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重度抑郁症认知缺陷的数字干预：一项评估成人疗效和安全性的随机对照试验

客观的：

作者评估了 AKL-T03，这是一种通过基于视频游戏的界面提供的研究性数字干预，旨在针对额顶叶网络，以增强注意力控制的功能域。AKL-T03 在患有重度抑郁症且基线时表现出认知障碍的成年患者中进行了测试。

方法：

年龄在 25-55 岁的成年人接受了稳定的抗抑郁药物治疗，并伴有轻度至中度抑郁症和客观的认知障碍（使用符号编码测试测量），他们参加了一项双盲随机对照研究。参与者被随机分配到 AKL-T03 或预期匹配的数字控制干预。参与者在基线和完成为期 6 周的家庭干预后进行评估。主要结果测量是通过注意力变量测试 (TOVA) 测量的持续注意力的改善。

结果：

与对 TOVA 主要结果 (N=37) 的对照干预相比，AKL-T03 (N=37) 在持续关注方面显示出具有统计学意义的中等效应大小改善（部分 eta-squared=0.11）。此外，来自所有认知测量的综合评分表明 AKL-T03 比对照干预有显着改善。个别次要和探索性终点没有显示出统计学上显着的组间差异。没有报告严重的不良事件，AKL-T03 组中的两名患者（5.5%）报告了与干预相关的不良事件（头痛）。

结论：

与对照干预相比，AKL-T03 治疗可显着改善持续注意力以及整体认知功能。AKL-T03 是一种安全的数字干预措施，可有效治疗与重度抑郁症相关的认知障碍。需要进一步的研究来了解这种治疗引起的变化的临床后果。