title: Cognitive training plus a comprehensive psychosocial programme (OPUS) versus the comprehensive psychosocial programme alone for patients with first-episode schizophrenia (the NEUROCOM trial): a study protocol for a centrally randomised, observer-blinded multi-centre clinical trial.
abstract: BACKGROUND
  Up to 85% of patients with schizophrenia demonstrate cognitive dysfunction in at least one domain. Cognitive dysfunction plays a major role in functional outcome. It is hypothesized that addition of cognitive training to a comprehensive psychosocial programme (OPUS) enhances both cognitive and everyday functional capacity of patients more than the comprehensive psychosocial programme alone.
  
  
  METHODS
  The NEUROCOM trial examines the effect on cognitive functioning and everyday functional capacity of patients with schizophrenia of a 16-week manualised programme of individual cognitive training integrated in a comprehensive psychosocial programme versus the comprehensive psychosocial programme alone. The cognitive training consists of four modules focusing on attention, executive functioning, learning, and memory. Cognitive training involves computer-assisted training tasks as well as practical everyday tasks and calendar training. It takes place twice a week, and every other week the patient and trainer engage in a dialogue on the patient's cognitive difficulties, motivational goals, and progress in competence level. Cognitive training relies on errorless learning principles, scaffolding, and verbalisation in its effort to improve cognitive abilities and teach patients how to apply compensation strategies as well as structured problem solving techniques. At 16-week post-training and at ten-months follow-up, assessments are conducted to investigate immediate outcome and possible long-term effects of cognitive training. We conduct blinded assessments of cognition, everyday functional capacity and associations with the labour market, symptom severity, and self-esteem.
  
  
  CONCLUSIONS
  Results from four-month and ten-month follow-ups have the potential of reliably providing documentation of the long-term effect of CT for patients with schizophrenia.
  
  
  BACKGROUND
  Clinicaltrials.gov NCT00472862.
authors.affiliation: Psychiatric Centre Copenhagen, Copenhagen University Hospital, DK-2400, Copenhagen, Denmark. lone.vesterager@regionh.dk
authors.forename: Lone
authors.initials: L
authors.lastname: Vesterager
authors.forename: Torben Ø
authors.initials: TØ
authors.lastname: Christensen
authors.forename: Birthe B
authors.initials: BB
authors.lastname: Olsen
authors.forename: Gertrud
authors.initials: G
authors.lastname: Krarup
authors.forename: Hysse B
authors.initials: HB
authors.lastname: Forchhammer
authors.forename: Marianne
authors.initials: M
authors.lastname: Melau
authors.forename: Christian
authors.initials: C
authors.lastname: Gluud
authors.forename: Merete
authors.initials: M
authors.lastname: Nordentoft
mesh_terms: D000203:Activities of Daily Living; D000293:Adolescent; D000328:Adult; D001288:Attention; D003071:Cognition; D015928:Cognitive Behavioral Therapy; D003718:Denmark; D004651:Employment; D056344:Executive Function; D005260:Female; D006801:Humans; D007858:Learning; D008297:Male; D008568:Memory; D009483:Neuropsychological Tests; D011569:Psychiatric Status Rating Scales; D012107:Research Design; D012559:Schizophrenia / Q000175:diagnosis / Q000628:therapy*; D012565:Schizophrenic Psychology; D012649:Self Concept; D012720:Severity of Illness Index; D012944:Social Support; D013997:Time Factors; D016896:Treatment Outcome; D055815:Young Adult