• Anthony P Morrison, Douglas Turkington, Melissa Pyle, Helen Spencer, Alison Brabban, Graham Dunn, Tom Christodoulides, Rob Dudley, Nicola Chapman, Pauline Callcott, Tim Grace, Victoria Lumley, Laura Drage, Sarah Tully, Kerry Irving, Anna Cummings, Rory Byrne, Linda M Davies, and Paul Hutton.
• School of Psychological Sciences, University of Manchester, Manchester, UK; Greater Manchester West Mental Health NHS Foundation Trust, Manchester, UK. Electronic address: tony.morrison@manchester.ac.uk.
• Lancet. 2014 Apr 19; 383 (9926): 1395-403.

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.Copyright © 2014 Elsevier Ltd. All rights reserved.

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