School of Social and Community Medicine, University of Bristol, Oakfield House, Oakfield Road, Bristol, BS8 2BN, UK.
Contemp Clin Trials. 2012 Mar;33(2):312-9. doi: 10.1016/j.cct.2011.10.016. Epub 2011 Nov 11.
Antidepressants are often the first-line treatment for depression but only one third of patients respond fully to pharmacotherapy. This paper describes the protocol for a randomised controlled trial (RCT) designed to evaluate the clinical and cost effectiveness of cognitive behavioural therapy (CBT) as an adjunct to pharmacotherapy for patients with treatment resistant depression in primary care.
METHODS/DESIGN: CoBalT is a two parallel group multi-centre pragmatic RCT. Eligible participants were those who: (i) were aged 18-75years; (ii) were currently taking antidepressant medication (for at least 6weeks at an adequate dose); (iii) scored ≥14 on the Beck Depression Inventory (BDI-II); (iv) had adhered to their medication; and (v) met ICD-10 criteria for depression (assessed using the Clinical Interview Schedule - revised version). Those who gave written informed consent were randomised to one of two treatment groups: usual care or usual care plus CBT. The primary outcome is depressive symptoms assessed using the BDI-II at 6months post-randomisation. Secondary outcomes measured at 6 and 12months include quality of life, antidepressant use and health care utilisation. Outcomes will be analysed on an intention-to-treat basis.
The CoBalT trial will provide evidence on the clinical and cost effectiveness of CBT as an adjunct to antidepressant medication in the treatment of depression that has not responded to pharmacotherapy. Given the move to widen access to 'talking therapies', the results of this study will be timely.
抗抑郁药通常是治疗抑郁症的首选药物，但只有三分之一的患者对药物治疗有完全反应。本文介绍了一项随机对照试验（RCT）的方案，该试验旨在评估认知行为疗法（CBT）作为辅助药物治疗对初级保健中治疗抵抗性抑郁症患者的临床和成本效益。
方法/设计：CoBalT 是一项两平行组多中心实用 RCT。符合条件的参与者包括：（i）年龄在 18-75 岁之间；（ii）正在服用抗抑郁药物（至少在足够剂量下服用 6 周）；（iii）贝克抑郁量表（BDI-II）得分≥14；（iv）遵守药物治疗；（v）符合 ICD-10 抑郁症标准（使用临床访谈表-修订版评估）。那些书面同意的人被随机分配到两个治疗组之一：常规护理或常规护理加 CBT。主要结局是 6 个月后使用 BDI-II 评估的抑郁症状。6 个月和 12 个月时测量的次要结局包括生活质量、抗抑郁药使用和医疗保健利用。结果将基于意向治疗进行分析。
CoBalT 试验将提供有关 CBT 作为辅助抗抑郁药物治疗对药物治疗无反应的抑郁症的临床和成本效益的证据。鉴于扩大“谈话疗法”的机会，这项研究的结果将是及时的。
