Scott Jan, Bentall Richard, Kinderman Peter, Morriss Richard
Institute of Neuroscience, Newcastle University, Newcastle upon Tyne, UK.
Department of Psychology, University of Sheffield, Cathedral Court, 1 Vicar Lane, Sheffield, S1 2LT, England.
Int J Bipolar Disord. 2022 May 3;10(1):13. doi: 10.1186/s40345-022-00259-3.
Efficacy trials of medications and/or psychological interventions for bipolar disorders (BD) aim to recruit homogenous samples of patients who are euthymic and such populations show high levels of adherence to the treatments offered. This study describes a secondary analysis of a large-scale multi-centre pragmatic effectiveness randomized controlled trial (RCT) of cognitive behaviour therapy plus treatment as usual (CBT) or treatment as usual alone (TAU) and explores outcomes in individuals who were: (i) recruited in depressive episodes, or (ii) receiving suboptimal doses of or no mood stabilizers (MS).
Data were extract on two separate subsamples (out of 253 RCT participants). Sample 1 comprised 67 individuals in a depressive episode (CBT: 34; TAU: 33); Sample 2 comprised 39 individuals receiving suboptimal MS treatment (CBT: 19; TAU: 20). Survival analyses (adjusted for confounding variables) were used to explore recovery in Sample 1 and relapse in Sample 2.
In Sample 1 (individuals with depression), Cox proportional hazards regression model revealed that the median time to recovery was significantly shorter in the CBT group (10 weeks; 95% confidence intervals (CI) 8, 17) compared to the TAU group (17 weeks; 95% CI 9, 30) [Adjusted Hazard Ratio (HR) 1.89; 95% CI 1.04, 3.4; p < 0.035]. In Sample 2 (suboptimal MS), the median time to any relapse was significantly longer in the CBT group compared to the TAU group (~ 35 versus ~ 20 weeks; Adjusted HR 2.01; 95% CI 1.01, 3.96; p < 0.05) with the difference in survival time to first depressive relapse also reaching statistical significance (X = 14.23, df 6, p 0.027).
Adjunctive use of CBT appears to have benefits for individuals diagnosed with BD who are highly representative of the patients seen in routine clinical practice, but often excluded from efficacy RCTs. However, as this is a secondary analysis of 42% of the original RCT sample, it is important to replicate these findings in independent larger scale studies specifically designed for purpose.
双相情感障碍（BD）药物和/或心理干预的疗效试验旨在招募心境正常的同质患者样本，这类人群对所提供的治疗具有较高的依从性。本研究描述了一项大规模多中心实用有效性随机对照试验（RCT）的二次分析，该试验对比了认知行为疗法联合常规治疗（CBT）与单纯常规治疗（TAU），并探讨了以下两类个体的治疗结果：（i）在抑郁发作期招募的个体；（ii）接受次优剂量或未接受心境稳定剂（MS）治疗的个体。
从253名RCT参与者中提取了两个独立的子样本数据。样本1包括67名处于抑郁发作期的个体（CBT组：34名；TAU组：33名）；样本2包括39名接受次优MS治疗的个体（CBT组：19名；TAU组：20名）。采用生存分析（对混杂变量进行校正）来探究样本1中的康复情况和样本2中的复发情况。
在样本1（患有抑郁症的个体）中，Cox比例风险回归模型显示，与TAU组（17周；95%置信区间[CI]9, 30）相比，CBT组的中位康复时间显著更短（10周；95%CI 8, 17）[校正风险比（HR）1.89；95%CI 1.04, 3.4；p < 0.035]。在样本2（次优MS治疗）中，与TAU组相比，CBT组至任何复发的中位时间显著更长（约35周对约20周；校正HR 2.01；95%CI 1.01, 3.96；p < 0.05），至首次抑郁复发的生存时间差异也具有统计学意义（X = 14.23，自由度6，p 0.027）。
对于被诊断为BD且在常规临床实践中具有高度代表性，但通常被排除在疗效RCT之外的个体，辅助使用CBT似乎有益。然而，由于这是对原始RCT样本42%的二次分析，在专门为此目的设计的独立大规模研究中重复这些发现很重要。
