title: The FOCUS trial: cognitive remediation plus standard treatment versus standard treatment for patients at ultra-high risk for psychosis: study protocol for a randomised controlled trial.
abstract: BACKGROUND
  Cognitive deficits are a distinct feature among people at ultra-high risk (UHR) for psychosis and pose a barrier to functional recovery. Insufficient evidence exists on how to ameliorate these cognitive deficits in patients at UHR for psychosis and hence improve daily living and quality of life. The aim of the trial is to investigate whether cognitive remediation can improve cognitive and psychosocial function in patients at UHR for psychosis.
  
  
  METHODS
  The FOCUS trial (Function and Overall Cognition in Ultra-high risk States) is a randomised, parallel group, observer-blinded clinical trial enrolling 126 patients meeting the standardised criteria of being at UHR for psychosis. Patients are recruited from psychiatric in- and outpatient facilities in the Copenhagen catchment area. Patients are randomised to one of the two treatment arms: cognitive remediation plus standard treatment versus standard treatment. The cognitive remediation consists of 24 weekly group-based and manualised sessions targeting neurocognition and social cognition. In addition to the group sessions, the patients will be offered 12 individual sessions aiming at maximising the transfer of the effects of the cognitive training to their everyday lives. Follow-up assessments will be conducted at 6 and 12 months after randomisation. The primary outcome is the composite score on the Brief Assessment of Cognition in Schizophrenia at cessation of treatment after 6 months. Secondary outcomes are social and daily functioning, psychosis-like symptoms, negative symptomatology, and depressive symptomatology as measured with the Personal and Social Performance Scale, Brief Psychiatric Rating Scale-Expanded Version, Scale for the Assessment of Negative Symptoms, and the Montgomery-Åsberg Depression Rating Scale.
  
  
  CONCLUSIONS
  This is the first trial to evaluate the effects of neurocognitive and social cognitive remediation in UHR patients. The FOCUS trial results will provide evidence on the effect of targeted and comprehensive cognitive rehabilitation on cognition, daily living, and symptomatology as well as long-term outcome in preventing transition to psychosis in UHR patients.
  
  
  BACKGROUND
  ClinicalTrials.gov NCT 02098408 . Date of registration 18 March 2014.
authors.affiliation: Mental Health Centre Copenhagen, Copenhagen University Hospital, DK-2400, Copenhagen, Denmark. louise.birkedal.glenthoej@regionh.dk.|Centre for Clinical Intervention and Neuropsychiatric Schizophrenia Research, CINS, DK-2600, Glostrup, Denmark. louise.birkedal.glenthoej@regionh.dk.
authors.forename: Louise B
authors.initials: LB
authors.lastname: Glenthøj
authors.affiliation: Centre for Clinical Intervention and Neuropsychiatric Schizophrenia Research, CINS, DK-2600, Glostrup, Denmark. birgitte.fagerlund@regionh.dk.|Centre for Neuropsychiatric Schizophrenia Research (CNSR), Mental Health Centre Glostrup, Copenhagen University Hospital, DK-2600, Glostrup, Denmark. birgitte.fagerlund@regionh.dk.
authors.forename: Birgitte
authors.initials: B
authors.lastname: Fagerlund
authors.affiliation: Mental Health Centre Copenhagen, Copenhagen University Hospital, DK-2400, Copenhagen, Denmark. lasse.randers@regionh.dk.|Centre for Clinical Intervention and Neuropsychiatric Schizophrenia Research, CINS, DK-2600, Glostrup, Denmark. lasse.randers@regionh.dk.
authors.forename: Lasse
authors.initials: L
authors.lastname: Randers
authors.affiliation: Mental Health Centre Copenhagen, Copenhagen University Hospital, DK-2400, Copenhagen, Denmark. carsten.rygaard.hjorthoej@regionh.dk.
authors.forename: Carsten R
authors.initials: CR
authors.lastname: Hjorthøj
authors.affiliation: Mental Health Centre Copenhagen, Copenhagen University Hospital, DK-2400, Copenhagen, Denmark. christina.wenneberg@regionh.dk.|Centre for Clinical Intervention and Neuropsychiatric Schizophrenia Research, CINS, DK-2600, Glostrup, Denmark. christina.wenneberg@regionh.dk.
authors.forename: Christina
authors.initials: C
authors.lastname: Wenneberg
authors.affiliation: Mental Health Centre Copenhagen, Copenhagen University Hospital, DK-2400, Copenhagen, Denmark. kristine.krakauer@regionh.dk.|Centre for Clinical Intervention and Neuropsychiatric Schizophrenia Research, CINS, DK-2600, Glostrup, Denmark. kristine.krakauer@regionh.dk.
authors.forename: Kristine
authors.initials: K
authors.lastname: Krakauer
authors.affiliation: Mental Health Centre Copenhagen, Copenhagen University Hospital, DK-2400, Copenhagen, Denmark. astrid.vosgerau@regionh.dk.|Centre for Rehabilitation for Brain Injury, DK-2300, Copenhagen, Denmark. astrid.vosgerau@regionh.dk.
authors.forename: Astrid
authors.initials: A
authors.lastname: Vosgerau
authors.affiliation: Copenhagen Trial Unit, Centre for Clinical Intervention Research, Department 7812, Rigshospitalet, Copenhagen University Hospital, DK-2100, Copenhagen, Denmark. cgluud@ctu.dk.
authors.forename: Christian
authors.initials: C
authors.lastname: Gluud
authors.affiliation: Columbia University Medical Center, New York, NY, 10032, USA. am2938@columbia.edu.
authors.forename: Alice
authors.initials: A
authors.lastname: Medalia
authors.affiliation: Department of Psychiatry, Division of Schizophrenia and Related Disorders, University of Texas Health Science Center, San Antonio, TX, 78229, USA. robertsd5@uthscsa.edu.
authors.forename: David L
authors.initials: DL
authors.lastname: Roberts
authors.affiliation: Mental Health Centre Copenhagen, Copenhagen University Hospital, DK-2400, Copenhagen, Denmark. merete.nordentoft@dadlnet.dk.|Centre for Clinical Intervention and Neuropsychiatric Schizophrenia Research, CINS, DK-2600, Glostrup, Denmark. merete.nordentoft@dadlnet.dk.
authors.forename: Merete
authors.initials: M
authors.lastname: Nordentoft
mesh_terms: D000293:Adolescent; D000328:Adult; D002985:Clinical Protocols; D003071:Cognition; D003627:Data Interpretation, Statistical; D006801:Humans; D011618:Psychotic Disorders / Q000523:psychology / Q000628:therapy*; D012306:Risk; D012559:Schizophrenia / Q000628:therapy