a randomised controlled trial (MATISSE). - ResearchGate

DOI: 10.3310/hta16080
Chapter 4
Results
Recruitment and randomisation
Health Technology Assessment 2012; Vol. 16: No. 8
Study recruitment commenced in February 2007. The rate of recruitment was slower than
anticipated. Interviews with front-line staff conducted to explore this suggested that this was
the result of several interconnected factors. 53 These included pressure of clinical work, which
had intensified following reconfiguration of services. Clinical staff did not view involvement in
research as a priority. Moreover, clinicians had concerns about the rationale for the study and the
ethical issues it raised. Some considered it unfair to withhold art therapy from people who were
interested in receiving it, whereas others reported being unclear about what art therapy involved
and whether or not mental health services should be referring people for this treatment. 57 In
response to these difficulties, we convened a range of formal and informal meetings with clinical
staff to publicise the study and address these concerns. We also increased the number of sites that
we recruited from and extended the period of recruitment.
Between February 2007 and the end of August 2008, 649 people were formally assessed for
participation in the study. Of these, 417 (64%) were eligible and were randomised. The reasons
for non-participation were: not willing to provide consent (n = 167, 72%), not having a diagnosis
of schizophrenia (n = 41, 18%), already receiving an arts therapy at the point of the assessment
(n = 15, 6%), moderate or severe cognitive impairment (n = 6, 3%) and insufficient spoken English
to complete the BSL assessment (n = 3, 1%). A total of 131 participants were recruited in west
London, 115 in north London, 103 in the west of England and 68 in Belfast. Of the 417 people
who took part in the study, 140 were allocated to group art therapy, 140 were allocated to the
activity group and 137 to standard care.
Reliability of Global Assessment of Functioning Scale ratings
Inter-rater reliability of researcher GAF ratings was assessed during the first year of the study.
Researchers independently rated 24 written-case vignettes. Using a two-way mixed-effects model,
the ICC was found to be 0.57 [95% confidence interval (CI) 0.41 to 0.74].
Characteristics of the study sample at baseline
The sociodemographic and clinical characteristics of study participants at BSL are presented in
Table 1. Participants ranged in age from 18 to 72 years and two-thirds (n = 279, 67%) were male.
Around three-quarters described their ethnicity as white and the remainder reported being from
black and minority ethnic groups. The majority were single (n = 333, 80%) and had not achieved
a higher education degree (n = 359, 89%). The median age at the onset of psychiatric illness was
22 years.
The results of BSL assessments are presented in Table 2. The mean GAF score at BSL was 45
(range 9 to 77). All study participants were rated as having some degree of impairment, with the
majority having moderate impairment and poor mental health. Despite this, participants’ mean
© 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.
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