Objective: To examine the clinical effectiveness and cost-effectiveness of referral to group art therapy plus standard care, compared with referral to an activity group plus standard care and standard care alone, among people with schizophrenia. Design: A three-arm, parallel group, single-blind, pragmatic, randomised controlled trial. Participants were randomised via an independent and remote telephone randomisation service using permuted blocks, stratified by study centre. Setting: Study participants were recruited from secondary care mental health and social services in four UK centres. Participants: Potential participants were aged 18 years or over, had a clinical diagnosis of schizophrenia, confirmed by an examination of case notes, and provided written informed consent. We excluded those who were unable to speak sufficient English to complete the baseline assessment, those with severe cognitive impairment and those already receiving arts therapy. Interventions: Group art therapy was delivered by registered art therapists according to nationally agreed standards. Groups had up to eight members, lasted for 90 minutes and ran for 12 months. Members were given access to a range of art materials and encouraged to use these to express themselves freely. Activity groups were designed to control for the non-specific effects of group art therapy. Group facilitators offered various activities and encouraged participants to collectively select those they wanted to pursue. Standard care involved follow-up from secondary care mental health services and the option of referral to other services, except arts therapies, as required. Main outcome measures: Our co-primary outcomes were global functioning (measured using the Global Assessment of Functioning Scale – GAF) and mental health symptoms (measured using the Positive and Negative Syndrome Scale – PANSS) at 24 months. The main secondary outcomes were level of group attendance, social functioning, well-being,
© Queen's Printer and Controller of HMSO 2012. This work was produced by Crawford et al under the terms of a commissioning contract issued by the Secretary of State for Health. Dianne Waller on behalf of the MATISSE project team.