The primary outcome was feasibility (ie, data on trial referral and recruitment, session attendance or medication adherence, retention, and treatment acceptability) and the proposed primary efficacy outcome was total score on the Positive and Negative Syndrome Scale (PANSS) at 6 months. Participants were followed up for a maximum of 12 months. Choice and dose of antipsychotic were at the discretion of the treating consultant psychiatrist. CBT incorporated up to 26 sessions over 6 months plus up to four booster sessions, and family intervention incorporated up to six sessions over 6 months. Randomisation was via a web-based randomisation system, with permuted blocks of random size, stratified by centre and family contact. Participants were assigned (1:1:1) to antipsychotics, psychological intervention (CBT with optional family intervention), or antipsychotics plus psychological intervention. Participants were aged 14-18 years help-seeking had presented with first-episode psychosis in the past year were under the care of a psychiatrist were showing current psychotic symptoms and met ICD-10 criteria for schizophrenia, schizoaffective disorder, or delusional disorder, or met the entry criteria for an early intervention for psychosis service. We recruited participants from seven UK National Health Service Trust sites. We did a multicentre pilot and feasibility trial according to a randomised, single-blind, three-arm, controlled design. The aim of this study was to establish the feasibility of a randomised controlled trial of antipsychotic monotherapy, psychological intervention monotherapy, and antipsychotics plus psychological intervention in adolescents with first-episode psychosis. The UK National Institute for Health and Care Excellence has recommended evaluation of the clinical effectiveness and cost-effectiveness of antipsychotic drugs versus psychological intervention (cognitive behavioural therapy and family intervention) versus the combination of these treatments for early-onset psychosis. Current guidance for the treatment of early-onset psychosis is mostly extrapolated from trials in adult populations. 12 National Institute for Health Research (NIHR) MindTech MedTech Co-operative and NIHR Nottingham Biomedical Research Centre, Division of Psychiatry and Applied Psychology, Institute of Mental Health, University of Nottingham, Nottingham, UK.Įvidence for the effectiveness of treatments in early-onset psychosis is sparse.11 Psychosis Research Unit, Greater Manchester Mental Health National Health Service (NHS) Foundation Trust, Prestwich, UK.10 Edinburgh Clinical Trials Unit, University of Edinburgh Medical School, Edinburgh, UK.9 The Centre for Healthcare Randomised Trials, Health Services Research Unit, University of Aberdeen, Aberdeen, UK.
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