title: Cognitive therapy for people with schizophrenia spectrum disorders not taking antipsychotic drugs: a single-blind randomised controlled trial.
abstract: BACKGROUND
  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.
  
  
  METHODS
  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.
  
  
  RESULTS
  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).
  
  
  CONCLUSIONS
  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.
  
  
  BACKGROUND
  National Institute for Health Research.
authors: 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.
authors: Anthony P
authors: AP
authors: Morrison
authors: Newcastle University, Newcastle-upon-Tyne, UK; Northumberland, Tyne and Wear NHS Mental Health Foundation Trust, Newcastle-upon-Tyne, UK.
authors: Douglas
authors: D
authors: Turkington
authors: School of Psychological Sciences, University of Manchester, Manchester, UK; Greater Manchester West Mental Health NHS Foundation Trust, Manchester, UK.
authors: Melissa
authors: M
authors: Pyle
authors: Newcastle University, Newcastle-upon-Tyne, UK; Northumberland, Tyne and Wear NHS Mental Health Foundation Trust, Newcastle-upon-Tyne, UK.
authors: Helen
authors: H
authors: Spencer
authors: University of Durham, Durham, UK; Tees, Esk, and Wear Valley NHS Mental Health Foundation Trust, County Durham, UK.
authors: Alison
authors: A
authors: Brabban
authors: Centre for Biostatistics, University of Manchester, Manchester, UK.
authors: Graham
authors: G
authors: Dunn
authors: Northumberland, Tyne and Wear NHS Mental Health Foundation Trust, Newcastle-upon-Tyne, UK.
authors: Tom
authors: T
authors: Christodoulides
authors: Newcastle University, Newcastle-upon-Tyne, UK; Northumberland, Tyne and Wear NHS Mental Health Foundation Trust, Newcastle-upon-Tyne, UK.
authors: Rob
authors: R
authors: Dudley
authors: School of Psychological Sciences, University of Manchester, Manchester, UK; Greater Manchester West Mental Health NHS Foundation Trust, Manchester, UK.
authors: Nicola
authors: N
authors: Chapman
authors: Northumberland, Tyne and Wear NHS Mental Health Foundation Trust, Newcastle-upon-Tyne, UK.
authors: Pauline
authors: P
authors: Callcott
authors: Tees, Esk, and Wear Valley NHS Mental Health Foundation Trust, County Durham, UK.
authors: Tim
authors: T
authors: Grace
authors: Tees, Esk, and Wear Valley NHS Mental Health Foundation Trust, County Durham, UK.
authors: Victoria
authors: V
authors: Lumley
authors: Greater Manchester West Mental Health NHS Foundation Trust, Manchester, UK.
authors: Laura
authors: L
authors: Drage
authors: School of Psychological Sciences, University of Manchester, Manchester, UK; Greater Manchester West Mental Health NHS Foundation Trust, Manchester, UK.
authors: Sarah
authors: S
authors: Tully
authors: Greater Manchester West Mental Health NHS Foundation Trust, Manchester, UK.
authors: Kerry
authors: K
authors: Irving
authors: Newcastle University, Newcastle-upon-Tyne, UK; Northumberland, Tyne and Wear NHS Mental Health Foundation Trust, Newcastle-upon-Tyne, UK.
authors: Anna
authors: A
authors: Cummings
authors: Greater Manchester West Mental Health NHS Foundation Trust, Manchester, UK.
authors: Rory
authors: R
authors: Byrne
authors: Centre for Health Economics, Institute of Population Health, University of Manchester, Manchester, UK.
authors: Linda M
authors: LM
authors: Davies
authors: School of Psychological Sciences, University of Manchester, Manchester, UK; Greater Manchester West Mental Health NHS Foundation Trust, Manchester, UK.
authors: Paul
authors: P
authors: Hutton
mesh_terms: D014150:Antipsychotic Agents; D015928:Cognitive Behavioral Therapy; D004739:England; D005240:Feasibility Studies; D005260:Female; D006801:Humans; D008297:Male; D012559:Schizophrenia / Q000628:therapy*; D016037:Single-Blind Method; D011795:Surveys and Questionnaires; D016896:Treatment Outcome; D016312:Treatment Refusal / Q000523:psychology*
chemical_list: D014150:Antipsychotic Agents