The FOCUS trial is a randomised controlled trial, funded by the NIHR HTA programme, assessing whether cognitive behaviour therapy (CBT) is an effective treatment for individuals who have experience of psychosis and whose symptoms have been unresponsive to the anti-psychotic medication ‘clozapine’. We have recruited 487 participants to the trial across five sites in the UK: Hampshire, Manchester, Newcastle, Glasgow and Edinburgh.
Eligible participants who consented to take part were randomly allocated to either treatment as usual, which means they continued on with their usual care OR treatment as usual plus CBT. Those participants who were allocated to CBT were offered up to 30 sessions of CBT over the course of 9 months. In addition, all participants were asked to meet with a research assistant for a follow up appointment at 9 months and 21 months.
The primary outcome is the Positive and Negative Syndrome Scale (PANSS), a 30-item rating scale designed to provide a comprehensive assessment of psychopathology in adult patients with schizophrenia.
FOCUS is led by Professor Tony Morrison based at the University of Manchester and Greater Manchester West Mental Health NHS Foundation Trust. The project started on the 1st December 2012, and we have submitted findings for publication.
Protocol available published at https://bmcpsychiatry.biomedcentral.com/articles/10.1186/s12888-016-0983-6