Cognitive therapy for people with schizophrenia spectrum disorders not taking antipsychotic drugs: a single-blind randomised controlled trial

Cognitive therapy for people with schizophrenia spectrum disorders not taking antipsychotic drugs: a single-blind randomised controlled trial
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DOI:
10.1016/s0140-6736(13)62246-1
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发表时间:
2014-04
期刊:
The Lancet
影响因子:
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通讯作者:
A. Morrison;D. Turkington;M. Pyle;H. Spencer;A. Brabban;G. Dunn;T. Christodoulides;R. Dudley;Nicola H Chapman;P. Callcott;T. Grace;Victoria Lumley;Laura Drage;S. Tully;Kerry Irving;Anna Cummings;R. Byrne;L. Davies;P. Hutton
A. Morrison;D. Turkington;M. Pyle;H. Spencer;A. Brabban;G. Dunn;T. Christodoulides;R. Dudley;Nicola H Chapman;P. Callcott;T. Grace;Victoria Lumley;Laura Drage;S. Tully;Kerry Irving;Anna Cummings;R. Byrne;L. Davies;P. Hutton
中科院分区:
其他
文献类型:
--
作者:
A. Morrison;D. Turkington;M. Pyle;H. Spencer;A. Brabban;G. Dunn;T. Christodoulides;R. Dudley;Nicola H Chapman;P. Callcott;T. Grace;Victoria Lumley;Laura Drage;S. Tully;Kerry Irving;Anna Cummings;R. Byrne;L. Davies;P. Hutton

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背景:抗精神病药物通常是治疗精神分裂症的一线药物;然而,许多患者拒绝或停止他们的药物治疗。我们的目的是确定认知疗法在减少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方面是否有效。方法我们于2010年2月15日至2013年5月30日在两个英国中心进行了一项单盲随机对照试验。年龄在16-65岁的精神分裂症谱系障碍患者,选择不服用抗精神病药物,通过计算机系统随机分配(1:1),分组大小为4或6,接受认知治疗加常规治疗,或单独治疗。随机化按研究地点分层。结果评估者被分组分配。我们的主要结局是阳性和阴性综合征量表(PANSS)的总分,我们在基线和第3、6、9、12、15和18个月进行评估。通过意向治疗进行分析,采用ANCOVA模型调整部位、年龄、性别和基线症状。本研究注册为国际标准随机对照试验,注册号为29607432。研究结果: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)。认知治疗组的平均PANSS总分始终低于常规治疗组,估计组间效应值为- 6.52 (95% CI为- 10.79至- 2.25;p= 0.003)。我们记录了8起严重的不良事件:2起发生在认知治疗组(1起试图过量用药,1起患者在治疗后对他人构成风险),6起发生在常规治疗组(2起死亡,均被认为与参与试验或精神健康无关;3起根据《精神卫生法》强制入院治疗;1起试图过量用药)。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选择。应该为这些人提供循证治疗。需要进行更大规模、更明确的试验。资助国家健康研究所。
BackgroundAntipsychotic 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.MethodsWe 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.Findings74 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).InterpretationCognitive 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.FundingNational Institute for Health Research.