title: Clinical effectiveness of a staff training intervention in mental health inpatient rehabilitation units designed to increase patients' engagement in activities (the Rehabilitation Effectiveness for Activities for Life [REAL] study): single-blind, cluster-randomised controlled trial.
abstract: BACKGROUND
  Mental health inpatient rehabilitation services focus on people with complex psychosis who have, for example, treatment-refractory symptoms, cognitive impairment, and severe negative symptoms, which impair functioning and require lengthy admission. Engagement in activities could lead to improvement in negative symptoms and function, but few trials have been done. We aimed to investigate the effectiveness of a staff training intervention to increase patients' engagement in activities.
  
  
  METHODS
  We did a single-blind, two-arm, cluster-randomised controlled trial in 40 mental health inpatient rehabilitation units across England. Units were randomly allocated to either a manual-based staff training programme delivered by a small intervention team (intervention group, n=20) or standard care (control group, n=20). The primary outcome was patients' engagement in activities 12 months after randomisation, measured with the time use diary. With this measure, both the degree of engagement in an activity and its complexity are recorded four times a day for a week, rated on a scale of 0-4 for every period (maximum score of 112). Analysis was by intention-to-treat. Random-effects models were used to compare outcomes between study groups. Cost-effectiveness was assessed by combining service costs with the primary outcome. This study is registered with Current Controlled Trials (ISRCTN25898179).
  
  
  RESULTS
  Patients' engagement in activities did not differ between study groups (coefficient 1·44, 95% CI -1·35 to 4·24). An extra £101 was needed to achieve a 1% increase in patients' engagement in activities with the study intervention.
  
  
  CONCLUSIONS
  Our training intervention did not increase patients' engagement in activities after 12 months of follow-up. This failure could be attributable to inadequate implementation of the intervention, a high turnover of patients in the intervention units, competing priorities on staff time, high levels of patients' morbidity, and ceiling effects because of the high quality of standard care delivered. Further studies are needed to identify interventions that can improve outcomes for people with severe and complex psychosis.
  
  
  BACKGROUND
  National Institute for Health Research.
authors.affiliation: Division of Psychiatry, University College London, London, UK. Electronic address: h.killaspy@ucl.ac.uk.
authors.forename: Helen
authors.initials: H
authors.lastname: Killaspy
authors.affiliation: Department of Primary Care and Population Health, University College London, London, UK; UCL PRIMENT Clinical Trials Unit, London, UK.
authors.forename: Louise
authors.initials: L
authors.lastname: Marston
authors.affiliation: Division of Psychiatry, University College London, London, UK.
authors.forename: Nicholas
authors.initials: N
authors.lastname: Green
authors.affiliation: Division of Psychiatry, University College London, London, UK.
authors.forename: Isobel
authors.initials: I
authors.lastname: Harrison
authors.affiliation: Division of Psychiatry, University College London, London, UK.
authors.forename: Melanie
authors.initials: M
authors.lastname: Lean
authors.affiliation: Centre for Health and Social Care Research, Faculty of Health and Wellbeing, Sheffield Hallam University, Sheffield, UK.
authors.forename: Sarah
authors.initials: S
authors.lastname: Cook
authors.affiliation: Centre for Professional and Organisational Development, Faculty of Health and Wellbeing, Sheffield Hallam University, Sheffield, UK.
authors.forename: Tim
authors.initials: T
authors.lastname: Mundy
authors.affiliation: Health Service and Population Research Department, Institute of Psychiatry, King's College London, London, UK.
authors.forename: Thomas
authors.initials: T
authors.lastname: Craig
authors.affiliation: Maudsley Hospital, London, UK.
authors.forename: Frank
authors.initials: F
authors.lastname: Holloway
authors.affiliation: Bamford Centre for Mental Health and Wellbeing, University of Ulster, Derry, UK.
authors.forename: Gerard
authors.initials: G
authors.lastname: Leavey
authors.affiliation: Centre for the Economics of Mental and Physical Health, Institute of Psychiatry, King's College London, London, UK.
authors.forename: Leonardo
authors.initials: L
authors.lastname: Koeser
authors.affiliation: Centre for the Economics of Mental and Physical Health, Institute of Psychiatry, King's College London, London, UK.
authors.forename: Paul
authors.initials: P
authors.lastname: McCrone
authors.affiliation: Division of Psychiatry, University College London, London, UK.
authors.forename: Maurice
authors.initials: M
authors.lastname: Arbuthnott
authors.affiliation: Department of Statistical Science, University College London, London, UK; UCL PRIMENT Clinical Trials Unit, London, UK.
authors.forename: Rumana Z
authors.initials: RZ
authors.lastname: Omar
authors.affiliation: Division of Psychiatry, University College London, London, UK; UCL PRIMENT Clinical Trials Unit, London, UK.
authors.forename: Michael
authors.initials: M
authors.lastname: King
mesh_terms: D004739:England; D006801:Humans; D007297:Inpatients; D008503:Medical Staff / Q000193:education*; D008605:Mental Health Services; D000067250:Psychiatric Rehabilitation / Q000379:methods*; D016037:Single-Blind Method; D016896:Treatment Outcome