Copenhagen Affective Disorder Research Center (CADIC), Psychiatric Centre Copenhagen, Copenhagen University Hospital, Rigshospitalet, Copenhagen, Denmark.
Department of Clinical Medicine, University of Copenhagen, Copenhagen, Denmark.
Bipolar Disord. 2021 Aug;23(5):487-499. doi: 10.1111/bdi.13021. Epub 2020 Oct 29.
Cognitive impairment affects many patients with bipolar disorder (BD), and treatments with replicated pro-cognitive effects are lacking. This study aimed to assess the effect of Action-Based Cognitive Remediation (ABCR) vs control treatment on cognitive impairment in patients with BD.
Patients with remitted BD with objective cognitive impairment were randomized to 10 weeks of ABCR vs control treatment, and assessed at baseline, after 2 weeks of treatment, at treatment completion and at 6 months follow-up. The primary outcome was a cognitive composite score. Secondary outcomes were executive function and observer-rated functional capacity. Tertiary measures included additional neuropsychological tests, performance-based functional capacity and quality of life. Data were analysed with linear mixed effects models.
In total, 64 participants were randomized; given three dropouts before the baseline assessments, data were analysed for 61 participants (ABCR: n = 32, control: n = 29). There was no effect on ABCR vs control on the primary cognitive composite score (P-values ≥.60). At treatment completion, there was a large effect of ABCR vs control on the secondary executive function measure (treatment effect= -0.16, 95% CI [-0.27, -0.05], P ≤ .01, d = 0.65), and on subjective cognitive functioning (treatment effect = -5.38, 95% CI [-8.13, -2.67], P ≤ .001, d = 0.80), which disappeared at follow-up. There was no treatment-effect on functioning, and no association between cognitive and functional change.
There was no effect of ABCR on the cognitive composite score. However, there was an effect on executive function and subjective cognitive functioning suggesting that ABCR may be relevant for patients with executive dysfunction.
ClinicalTrials.gov identifier: NCT03295305.
认知障碍影响许多双相情感障碍（BD）患者，缺乏具有复制认知效果的治疗方法。本研究旨在评估基于行动的认知矫正（ABCR）与对照治疗对 BD 患者认知障碍的影响。
对有客观认知障碍的缓解期 BD 患者进行随机分组，接受 10 周的 ABCR 与对照治疗，并在基线、治疗 2 周后、治疗结束时和 6 个月随访时进行评估。主要结局是认知综合评分。次要结局是执行功能和观察者评定的功能能力。三级措施包括额外的神经心理学测试、基于表现的功能能力和生活质量。数据采用线性混合效应模型进行分析。
共随机分配 64 名参与者；在基线评估前有 3 名脱落者，对 61 名参与者（ABCR：n=32，对照：n=29）进行了数据分析。ABCR 与对照在主要认知综合评分上没有差异（P 值≥.60）。在治疗结束时，ABCR 与对照在次要执行功能测量上有显著效果（治疗效果=-0.16，95%CI[-0.27，-0.05]，P≤.01，d=0.65），以及主观认知功能（治疗效果=-5.38，95%CI[-8.13，-2.67]，P≤.001，d=0.80），在随访时消失。在功能方面没有治疗效果，认知和功能变化之间也没有关联。
ABCR 对认知综合评分没有影响。然而，ABCR 对执行功能和主观认知功能有影响，这表明 ABCR 可能对执行功能障碍的患者有意义。
ClinicalTrials.gov 标识符：NCT03295305。
