Centre for Mental Health, Addiction and Suicide Research, School of Social and Community Medicine, University of Bristol, Bristol, UK.
Lancet. 2013 Feb 2;381(9864):375-84. doi: 10.1016/S0140-6736(12)61552-9. Epub 2012 Dec 7.
Only a third of patients with depression respond fully to antidepressant medication but little evidence exists regarding the best next-step treatment for those whose symptoms are treatment resistant. The CoBalT trial aimed to examine the effectiveness of cognitive behavioural therapy (CBT) as an adjunct to usual care (including pharmacotherapy) for primary care patients with treatment resistant depression compared with usual care alone.
This two parallel-group multicentre randomised controlled trial recruited 469 patients aged 18-75 years with treatment resistant depression (on antidepressants for ≥6 weeks, Beck depression inventory [BDI] score ≥14 and international classification of diseases [ICD]-10 criteria for depression) from 73 UK general practices. Participants were randomised, with a computer generated code (stratified by centre and minimised according to baseline BDI score, whether the general practice had a counsellor, previous treatment with antidepressants, and duration of present episode of depression) to one of two groups: usual care or CBT in addition to usual care, and were followed up for 12 months. Because of the nature of the intervention it was not possible to mask participants, general practitioners, CBT therapists, or researchers to the treatment allocation. Analyses were by intention to treat. The primary outcome was response, defined as at least 50% reduction in depressive symptoms (BDI score) at 6 months compared with baseline. This trial is registered, ISRCTN38231611.
Between Nov 4, 2008, and Sept 30, 2010, we assigned 235 patients to usual care, and 234 to CBT plus usual care. 422 participants (90%) were followed up at 6 months and 396 (84%) at 12 months, finishing on Oct 31, 2011. 95 participants (46%) in the intervention group met criteria for response at 6 months compared with 46 (22%) in the usual care group (odds ratio 3·26, 95% CI 2·10-5·06, p<0·001).
Before this study, no evidence from large-scale randomised controlled trials was available for the effectiveness of augmentation of antidepressant medication with CBT as a next-step for patients whose depression has not responded to pharmacotherapy. Our study has provided robust evidence that CBT as an adjunct to usual care that includes antidepressants is an effective treatment, reducing depressive symptoms in this population.
National Institute for Health Research Health Technology Assessment.
仅有三分之一的抑郁症患者对抗抑郁药物治疗有完全反应，但对于那些症状治疗抵抗的患者，最好的下一步治疗方法几乎没有证据。CoBalT 试验旨在检验认知行为疗法（CBT）作为辅助治疗与单独常规护理（包括药物治疗）对治疗抵抗性抑郁症的初级保健患者的有效性，与单独常规护理相比。
这是一项在英国 73 家普通诊所招募的年龄在 18-75 岁之间、治疗抵抗性抑郁症（抗抑郁药物治疗≥6 周，贝克抑郁量表[BDI]评分≥14 分，国际疾病分类[ICD]-10 抑郁症标准）的 469 例患者的平行组、多中心、随机对照试验。参与者按计算机生成的代码（按中心分层，根据基线 BDI 评分、普通诊所是否有咨询师、以前是否接受过抗抑郁药物治疗以及目前抑郁发作的持续时间进行最小化）随机分为两组之一：常规护理或 CBT 加常规护理，并随访 12 个月。由于干预措施的性质，无法对参与者、全科医生、CBT 治疗师或研究人员进行盲法处理。分析采用意向治疗。主要结局是反应，定义为与基线相比，6 个月时抑郁症状（BDI 评分）至少减少 50%。本试验已注册，ISRCTN38231611。
2008 年 11 月 4 日至 2010 年 9 月 30 日，我们将 235 例患者分配至常规护理组，234 例患者分配至 CBT 加常规护理组。在 6 个月时，422 名参与者（90%）接受了随访，在 12 个月时，396 名参与者（84%）接受了随访，随访于 2011 年 10 月 31 日结束。干预组有 95 名参与者（46%）在 6 个月时符合反应标准，而常规护理组有 46 名参与者（22%）（比值比 3.26，95%CI 2.10-5.06，p<0.001）。
在这项研究之前，没有大规模随机对照试验的证据表明，在抗抑郁药物治疗后抑郁症未得到缓解的患者中，用 CBT 增强抗抑郁药物治疗作为下一步治疗是有效的。我们的研究提供了有力的证据，表明 CBT 作为常规护理的辅助治疗（包括抗抑郁药物）是一种有效的治疗方法，可以减轻这一人群的抑郁症状。
英国国家卫生研究院健康技术评估。
