title: Study protocol: cluster randomised controlled trial to assess the clinical and cost effectiveness of a staff training intervention in inpatient mental health rehabilitation units in increasing service users' engagement in activities.
abstract: BACKGROUND
  This study focuses on people with complex and severe mental health problems who require inpatient rehabilitation. The majority have a diagnosis of schizophrenia whose recovery has been delayed due to non-response to first-line treatments, cognitive impairment, negative symptoms and co-existing problems such as substance misuse. These problems contribute to major impairments in social and everyday functioning necessitating lengthy admissions and high support needs on discharge to the community. Engagement in structured activities reduces negative symptoms of psychosis and may lead to improvement in function, but no trials have been conducted to test the efficacy of interventions that aim to achieve this.
  
  
  METHODS
  This study aims to investigate the clinical and cost-effectiveness of a staff training intervention to increase service users' engagement in activities. This is a single-blind, two-arm cluster randomised controlled trial involving 40 inpatient mental health rehabilitation units across England. Units are randomised on an equal basis to receive either standard care or a "hands-on", manualised staff training programme comprising three distinct phases (predisposing, enabling and reinforcing) delivered by a small team of psychiatrists, occupational therapists, service users and activity workers. The primary outcome is service user engagement in activities 12 months after randomisation, assessed using a standardised measure. Secondary outcomes include social functioning and costs and cost-effectiveness of care.
  
  
  CONCLUSIONS
  The study will provide much needed evidence for a practical staff training intervention that has potential to improve service user functioning, reducing the need for hospital treatment and supporting successful community discharge. The trial is registered with Current Controlled Trials (Ref ISRCTN25898179).
authors: Helen
authors: H
authors: Killaspy
authors: Sarah
authors: S
authors: Cook
authors: Tim
authors: T
authors: Mundy
authors: Thomas
authors: T
authors: Craig
authors: Frank
authors: F
authors: Holloway
authors: Gerard
authors: G
authors: Leavey
authors: Louise
authors: L
authors: Marston
authors: Paul
authors: P
authors: McCrone
authors: Leonardo
authors: L
authors: Koeser
authors: Maurice
authors: M
authors: Arbuthnott
authors: Rumana Z
authors: RZ
authors: Omar
authors: Michael
authors: M
authors: King
mesh_terms: D003362:Cost-Benefit Analysis; D004517:Education, Professional / Q000191:economics*; D004739:England; D006760:Hospitalization; D006801:Humans; D007297:Inpatients; D001523:Mental Disorders / Q000534:rehabilitation*; D008603:Mental Health; D008605:Mental Health Services / Q000191:economics*; D012114:Residential Treatment / Q000191:economics*; D016037:Single-Blind Method
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