title: Study protocol: a randomised controlled trial of cognitive remediation for a national cohort of forensic mental health patients with schizophrenia or schizoaffective disorder.
abstract: BACKGROUND
  Evidence is accumulating that cognitive remediation therapy (CRT) is an effective intervention for patients with schizophrenia or schizoaffective disorder. To date there has been no randomised controlled trial (RCT) cohort study of cognitive remediation within a forensic hospital. The goal of this study is to examine the effectiveness of a trial of cognitive remediation for forensic mental health patients with schizophrenia or schizoaffective disorder.
  
  
  METHODS
  An estimated sixty patients will be enrolled in the study. Participants will be randomised to one of two conditions: CRT with treatment as usual (TAU), or TAU. CRT will consist of 42 individual sessions and 14 group sessions. The primary outcome measure for this study is change in cognitive functioning using the MATRICS Consensus Cognitive Battery (MCCB). Secondary outcomes include change in social and occupational functioning, disorganised symptoms, negative symptoms, violence, participation in psychosocial treatment and recovery. In addition to these effectiveness measures, we will examine patient satisfaction.
  
  
  CONCLUSIONS
  Cognitive difficulties experienced by schizophrenia spectrum patients are associated with general functioning, ability to benefit from psychosocial interventions and quality of life. Research into the treatment of cognitive difficulties within a forensic setting is therefore an important priority. The results of the proposed study will help answer the question whether cognitive remediation improves functional outcomes in forensic mental health patients with schizophrenia or schizoaffective disorder. Forensic mental health patients are detained for the dual purpose of receiving treatment and for public protection. There can be conflict between these two roles perhaps causing forensic services to have an increased length of stay compared to general psychiatric admissions. Ultimately a focus on emphasising cognition and general functioning over symptoms may decrease tension between the core responsibilities of forensic mental health services.
  
  
  BACKGROUND
  ClinicalTrials.gov Identifier: NCT02360813. Trial registered Feb 4th 2015 and last updated May 1(st) 2015.
authors.affiliation: Department of Psychiatry, Trinity College Dublin, Dublin, Ireland. oreillk5@tcd.ie.|National Forensic Mental Health Service, Central Mental Hospital, Dundrum, Dublin 14, Ireland. oreillk5@tcd.ie.
authors.forename: Ken
authors.initials: K
authors.lastname: O'Reilly
authors.affiliation: Department of Psychiatry, Trinity College Dublin, Dublin, Ireland. DONOGHUG@imx1.tcd.ie.
authors.forename: Gary
authors.initials: G
authors.lastname: Donohoe
authors.affiliation: National Forensic Mental Health Service, Central Mental Hospital, Dundrum, Dublin 14, Ireland. danny.osullivan2@hse.ie.
authors.forename: Danny
authors.initials: D
authors.lastname: O'Sullivan
authors.affiliation: National Forensic Mental Health Service, Central Mental Hospital, Dundrum, Dublin 14, Ireland. ciaran.coyle@hse.ie.
authors.forename: Ciaran
authors.initials: C
authors.lastname: Coyle
authors.affiliation: Department of Psychiatry, Trinity College Dublin, Dublin, Ireland. rmullan@tcd.ie.|National Forensic Mental Health Service, Central Mental Hospital, Dundrum, Dublin 14, Ireland. rmullan@tcd.ie.
authors.forename: Ronan
authors.initials: R
authors.lastname: Mullaney
authors.affiliation: Department of Psychiatry, Trinity College Dublin, Dublin, Ireland. paul.oconnell@hse.ie.|National Forensic Mental Health Service, Central Mental Hospital, Dundrum, Dublin 14, Ireland. paul.oconnell@hse.ie.
authors.forename: Paul
authors.initials: P
authors.lastname: O'Connell
authors.affiliation: National Forensic Mental Health Service, Central Mental Hospital, Dundrum, Dublin 14, Ireland. Catherine.maddock@hse.ie.
authors.forename: Catherine
authors.initials: C
authors.lastname: Maddock
authors.affiliation: National Forensic Mental Health Service, Central Mental Hospital, Dundrum, Dublin 14, Ireland. andrea.nulty@hse.ie.
authors.forename: Andrea
authors.initials: A
authors.lastname: Nulty
authors.affiliation: National Forensic Mental Health Service, Central Mental Hospital, Dundrum, Dublin 14, Ireland. padraic.oflynn@hse.ie.
authors.forename: Padraic
authors.initials: P
authors.lastname: O'Flynn
authors.affiliation: National Forensic Mental Health Service, Central Mental Hospital, Dundrum, Dublin 14, Ireland. carina.oconnell@hse.ie.
authors.forename: Carina
authors.initials: C
authors.lastname: O'Connell
authors.affiliation: Department of Psychiatry, Trinity College Dublin, Dublin, Ireland. kennedh@tcd.ie.|National Forensic Mental Health Service, Central Mental Hospital, Dundrum, Dublin 14, Ireland. kennedh@tcd.ie.
authors.forename: Harry G
authors.initials: HG
authors.lastname: Kennedy
mesh_terms: D000328:Adult; D000368:Aged; D002985:Clinical Protocols; D015928:Cognitive Behavioral Therapy / Q000379:methods*; D015331:Cohort Studies; D005260:Female; D005555:Forensic Psychiatry / Q000379:methods*; D006801:Humans; D008297:Male; D028642:Persons with Psychiatric Disorders / Q000331:legislation & jurisprudence / Q000523:psychology; D008875:Middle Aged; D017060:Patient Satisfaction; D011618:Psychotic Disorders / Q000523:psychology* / Q000628:therapy*; D011788:Quality of Life; D012559:Schizophrenia / Q000628:therapy*; D016896:Treatment Outcome