title: Cognitive remediation versus active computer control in bipolar disorder with psychosis: study protocol for a randomized controlled trial.
abstract: BACKGROUND
  Cognitive dysfunction is a major feature of bipolar disorder with psychosis and is strongly associated with functional outcomes. Computer-based cognitive remediation has shown promise in improving cognition in patients with schizophrenia. However, despite similar neurocognitive deficits between patients with schizophrenia and bipolar disorder, few studies have extended neuroscience-based cognitive remediation programs to this population.
  
  
  METHODS
  The Treatment to Enhance Cognition in Bipolar Disorder study is an investigator-initiated, parallel group, randomized, blinded clinical trial of an Internet-based cognitive remediation protocol for patients with bipolar disorder I with psychosis (n = 100). We also describe the development of our dose-matched active control paradigm. Both conditions involve 70 sessions of computer-based activities over 24 weeks. The control intervention was developed to mirror the treatment condition in dose and format but without the neuroplasticity-based task design and structure. All participants undergo neuropsychological and clinical assessment at baseline, after approximately 25 hours of study activities, post treatment, and after 6 months of no study contact to assess durability. Neuroimaging at baseline and post treatment are offered in an "opt-in" format. The primary outcomes are scores on the MATRICS battery; secondary and exploratory outcomes include measures of clinical symptoms, community functioning, and neuroimaging changes. Associations between change in cognitive measures and change in community functioning will be assessed. Baseline predictors of treatment response will be examined.
  
  
  CONCLUSIONS
  The present study is the first we are aware of to implement an Internet-based cognitive remediation program in patients with bipolar disorder with psychosis and to develop a comparable web-based control paradigm. The mixed online and study-site format allows accessible treatment while providing weekly staff contact and bridging. Based on user-provided feedback, participant blinding is feasible.
  
  
  BACKGROUND
  ClinicalTrials.gov NCT01470781 ; 11 July 2011.
authors.affiliation: McLean Hospital/Harvard Medical School, 115 Mill St., Belmont, MA, 02478, USA. klewandowski@mclean.harvard.edu.
authors.forename: Kathryn Eve
authors.initials: KE
authors.lastname: Lewandowski
authors.affiliation: McLean Hospital/Harvard Medical School, 115 Mill St., Belmont, MA, 02478, USA.
authors.forename: Sarah H
authors.initials: SH
authors.lastname: Sperry
authors.affiliation: McLean Hospital/Harvard Medical School, 115 Mill St., Belmont, MA, 02478, USA.
authors.forename: Dost
authors.initials: D
authors.lastname: Ongur
authors.affiliation: McLean Hospital/Harvard Medical School, 115 Mill St., Belmont, MA, 02478, USA.
authors.forename: Bruce M
authors.initials: BM
authors.lastname: Cohen
authors.affiliation: McLean Hospital/Harvard Medical School, 115 Mill St., Belmont, MA, 02478, USA.
authors.forename: Lesley A
authors.initials: LA
authors.lastname: Norris
authors.affiliation: Beth Israel Deaconess Medical Center/Harvard Medical School, 75 Fenwood Rd., Boston, MA, 02115, USA.
authors.forename: Matcheri S
authors.initials: MS
authors.lastname: Keshavan
mesh_terms: D000293:Adolescent; D000328:Adult; D001714:Bipolar Disorder / Q000175:diagnosis / Q000503:physiopathology / Q000523:psychology / Q000628:therapy*; D001921:Brain / Q000503:physiopathology*; D002985:Clinical Protocols; D003071:Cognition; D000072466:Cognitive Remediation / Q000379:methods*; D005260:Female; D006801:Humans; D020407:Internet; D008297:Male; D008404:Massachusetts; D008875:Middle Aged; D059906:Neuroimaging; D009473:Neuronal Plasticity; D009483:Neuropsychological Tests; D011569:Psychiatric Status Rating Scales; D011618:Psychotic Disorders / Q000175:diagnosis / Q000503:physiopathology / Q000523:psychology / Q000628:therapy*; D012107:Research Design; D013813:Therapy, Computer-Assisted / Q000379:methods*; D013997:Time Factors; D016896:Treatment Outcome; D055815:Young Adult
keywords: Bipolar disorder; Cognitive; Cognitive training; Control; Remediation; Trial