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ISRCTN
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ISRCTN46150447
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ClinicalTrials.gov identifier
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Public title
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Interactive group art therapy as an adjunctive treatment for people with schizophrenia
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Scientific title
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Acronym
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MATISSE
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Serial number at source
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HTA 04/39/04
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Study hypothesis
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1. Among people with schizophrenia, adjunctive interactive group art therapy is associated with improved global functioning at 24 months compared to attention control treatment or standard care alone
2. In the treatment of people with schizophrenia in secondary care settings, adjunctive interactive group art therapy is more cost-effective than attention control treatment or standard care alone
Please note that as of 01/05/2008 this trial received a 10-month extension, therefore the anticipated end date has been updated. The previous anticipated end date was 31/10/2009.
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Ethics approval
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Ethics approval received from the Cambridgeshire 1 Research Ethics Committee (formerly Huntingdon Research Ethics Committee) on the 8th September 2006 (ref: 06/Q0104/82).
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Study design
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Three arm, parallel, non-blinded randomised controlled trial
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Countries of recruitment
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United Kingdom
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Disease/condition/study domain
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Schizophrenia
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Participants - inclusion criteria
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All those treated by secondary mental health services in the four study centres who are aged over 18 years and have a clinical diagnosis of schizophrenia, confirmed by an examination of case notes using operationalised criteria (OPCRIT), will be eligible to take part in the study
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Participants - exclusion criteria
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1. Patients who are unwilling to provide written informed consent
2. Patients who speak insufficient English and are not able to complete baseline assessment
3. Have severe cognitive impairment
4. Are already receiving art therapy or any other art therapies (music therapy, drama therapy, or dance/ movement therapy)
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Anticipated start date
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01/11/2006
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Anticipated end date
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31/10/2010
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Status of trial
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Ongoing |
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Patient information material
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Target number of participants
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376
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Interventions
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The trial has three arms. As well as the intervention group (group art therapy) there are two other arms: attention control and treatment as usual. The attention control includes activity groups which will function in terms of structure, number of facilitators and number of participants in a similar manner to the group art therapy i.e. they will run weekly for 90 minutes with eight members and two facilitators. They will involve any activity with the exception of anything that uses art or art materials e.g. outings, current affairs discussion, newspaper groups, games etc. The treatment-as-usual arm will have no specific intervention.
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Primary outcome measure(s)
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Global functioning assessed using the Global Assessment of Functioning Scale
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Secondary outcome measure(s)
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1. Symptoms assessed using the Positive and Negative Syndrome Scale
2. Medication concordance will be assessed using the Morisky Scale
3. Quality of life will be assessed using Euroqol EQ-5D
4. Service costs will be assessed using the Client Service Receipt Inventory
5) Social function using the Social Function Schedule
6. Wellbeing will be assessed using the Psychological General Well Being Index
7. Satisfaction with services will be assessed using the Client Satisfaction Questionnaire
8. Engagement with services will be assessed using the Service Engagement Scale
9. Occupational and housing status
10. Adverse events
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Sources of funding
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NIHR Health Technology Assessment Programme - HTA (UK)
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Trial website
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Publications
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Contact name
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Dr
Helen
Killaspy
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Address
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Department of Mental Health Sciences
University College London
Second Floor
Royal Free Hospital
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City/town
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London
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Zip/Postcode
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NW3 2PF
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Country
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United Kingdom
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Tel
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+44 (0)207 794 0500 ext 33719
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Fax
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+44 (0)207 830 2808
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Email
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h.killaspy@medsch.ucl.ac.uk
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Sponsor
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Imperial College London (UK)
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Address
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South Kensington Campus
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City/town
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London
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Zip/Postcode
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SW7 2AZ
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Country
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United Kingdom
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Sponsor website:
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http://www3.imperial.ac.uk/
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Date applied
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05/06/2006
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Last edited
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25/08/2009
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Date ISRCTN assigned
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10/07/2006
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