School of Psychological Sciences, University of Manchester, Manchester, UK; Greater Manchester West Mental Health NHS Foundation Trust, Manchester, UK.
Newcastle University, Newcastle-upon-Tyne, UK; Northumberland, Tyne and Wear NHS Mental Health Foundation Trust, Newcastle-upon-Tyne, UK.
Lancet. 2014 Apr 19;383(9926):1395-403. doi: 10.1016/S0140-6736(13)62246-1. Epub 2014 Feb 6.
Antipsychotic drugs are usually the first line of treatment for schizophrenia; however, many patients refuse or discontinue their pharmacological treatment. We aimed to establish whether cognitive therapy was effective in reducing psychiatric symptoms in people with schizophrenia spectrum disorders who had chosen not to take antipsychotic drugs.
We did a single-blind randomised controlled trial at two UK centres between Feb 15, 2010, and May 30, 2013. Participants aged 16-65 years with schizophrenia spectrum disorders, who had chosen not to take antipsychotic drugs for psychosis, were randomly assigned (1:1), by a computerised system with permuted block sizes of four or six, to receive cognitive therapy plus treatment as usual, or treatment as usual alone. Randomisation was stratified by study site. Outcome assessors were masked to group allocation. Our primary outcome was total score on the positive and negative syndrome scale (PANSS), which we assessed at baseline, and at months 3, 6, 9, 12, 15, and 18. Analysis was by intention to treat, with an ANCOVA model adjusted for site, age, sex, and baseline symptoms. This study is registered as an International Standard Randomised Controlled Trial, number 29607432.
74 individuals were randomly assigned to receive either cognitive therapy plus treatment as usual (n=37), or treatment as usual alone (n=37). Mean PANSS total scores were consistently lower in the cognitive therapy group than in the treatment as usual group, with an estimated between-group effect size of -6.52 (95% CI -10.79 to -2.25; p=0.003). We recorded eight serious adverse events: two in patients in the cognitive therapy group (one attempted overdose and one patient presenting risk to others, both after therapy), and six in those in the treatment as usual group (two deaths, both of which were deemed unrelated to trial participation or mental health; three compulsory admissions to hospital for treatment under the mental health act; and one attempted overdose).
Cognitive therapy significantly reduced psychiatric symptoms and seems to be a safe and acceptable alternative for people with schizophrenia spectrum disorders who have chosen not to take antipsychotic drugs. Evidence-based treatments should be available to these individuals. A larger, definitive trial is needed.
National Institute for Health Research.
抗精神病药物通常是精神分裂症的一线治疗药物；然而，许多患者拒绝或停止接受药物治疗。我们旨在确定认知疗法是否能有效减轻选择不服用抗精神病药物的精神分裂症谱系障碍患者的精神症状。
我们在 2010 年 2 月 15 日至 2013 年 5 月 30 日在英国的两个中心进行了一项单盲随机对照试验。年龄在 16-65 岁之间、选择不服用抗精神病药物治疗精神病的精神分裂症谱系障碍患者被随机分配（1:1），使用计算机化系统，以 4 或 6 个为一组的随机块大小进行分组，接受认知疗法加常规治疗，或单独接受常规治疗。随机化按研究地点分层。结果评估者对分组分配不知情。我们的主要结局是阳性和阴性症状量表（PANSS）的总分，我们在基线时以及 3、6、9、12、15 和 18 个月时进行评估。分析按意向治疗进行，采用调整了地点、年龄、性别和基线症状的协方差分析模型。这项研究在国际标准随机对照试验注册库注册，编号为 29607432。
74 名患者被随机分配接受认知疗法加常规治疗（n=37）或单独接受常规治疗（n=37）。认知疗法组的 PANSS 总分始终低于常规治疗组，估计两组之间的效应大小为-6.52（95%CI -10.79 至 -2.25；p=0.003）。我们记录了 8 例严重不良事件：认知疗法组 2 例（1 例试图过量服药，1 例对他人构成风险，均发生在治疗后），常规治疗组 6 例（2 例死亡，均与试验参与或心理健康无关；3 例因精神卫生法规定而强制住院治疗；1 例试图过量服药）。
认知疗法显著减轻了精神症状，对于选择不服用抗精神病药物的精神分裂症谱系障碍患者来说，似乎是一种安全且可接受的替代方法。应向这些患者提供循证治疗。需要进行更大规模的、明确的试验。
英国国家卫生研究院。
