a randomised controlled trial (MATISSE). - ResearchGate

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4 Background for people with schizophrenia were still unclear. Moreover, because previous studies have not incorporated active control groups there is no evidence regarding the relative contribution of non-specific components and ‘active ingredients’ of the intervention to observed outcomes, nor has previous research examined the costs or cost-effectiveness of this intervention.
DOI: 10.3310/hta16080 Chapter 3 Methods Health Technology Assessment 2012; Vol. 16: No. 8 The MATISSE (Multicentre evaluation of Art Therapy In Schizophrenia: Systematic Evaluation) study was a three-arm, parallel-group, pragmatic, randomised controlled trial (RCT) of group art therapy plus standard care, control ‘activity’ group plus standard care or standard care alone. We used a pragmatic design that would allow us to test the impact of referring people to group art therapy in normal clinical practice. Three changes were made to the design of the study after commencement. First, because recruitment was slower than anticipated, the period for recruiting, the study sample was increased from 9 to 20 months. Second, following publication of national guidance on the treatment of schizophrenia highlighting the importance of arts therapies for people with residual symptoms of schizophrenia, 17 we promoted total symptom score as a co-primary outcome measure alongside Global Assessment of Functioning (GAF) Scale. Finally, early data demonstrating lower levels of attendance at groups than we anticipated led us to increase the total number of participants to 10% above our original target. Ethical approval for the study, including these protocol amendments, was given by Huntingdon Research Ethics Committee (06/Q0104/82) and the study protocol was registered with Controlled Clinical Trials (ISRCTN46150447) prior to the start of data collection. Study setting and sample Study participants were recruited from four UK centres: three in England (west London, north London, and Avon and Wiltshire) and one in Northern Ireland (Belfast). Centres were selected because they had systems for delivering group art therapy to people with schizophrenia, and for supervising and supporting arts therapists. The centres included a mix of inner city, urban, semirural and rural areas, and served a population that included people from a variety of different ethnic backgrounds. We recruited participants from secondary-care settings, including day hospitals, community mental health teams, rehabilitation services, supported accommodation and day centres. Although we identified and assessed potential participants from among those admitted to inpatient mental health units, randomisation did not take place until the person had been discharged from hospital. To take part in the study, at the point of randomisation potential participants had to be aged 18 years or over, living in the community and have a clinical diagnosis of schizophrenia, confirmed by an examination of case notes using operationalised criteria (OPCRIT). 19 Exclusion criteria were minimised to increase the external validity of study findings. We excluded those who were unwilling to provide written informed consent, those with severe cognitive impairment and those unable to speak sufficient English to complete the baseline (BSL) assessment. People who were currently receiving art therapy or another of the arts therapies (music, dance and movement or drama therapy) were excluded from the study, but those using other forms of structured psychosocial intervention were included. © 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. 5
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Feedback The HTA programme and the
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a randomised controlled trial (MATISSE). - ResearchGate

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