title: Effects of cognitive remediation on cognitive dysfunction in partially or fully remitted patients with bipolar disorder: study protocol for a randomized controlled trial.
abstract: BACKGROUND
  A large proportion of patients with bipolar disorder experience persistent cognitive dysfunction, such as memory, attention and planning difficulties, even during periods of full remission. The aim of this trial is to investigate whether cognitive remediation, a new psychological treatment, improves cognitive function and, in turn, psychosocial function in patients with bipolar disorder in partial or full remission.
  
  
  METHODS
  The trial has an evaluator-blind, randomized, between-groups design. Forty patients with bipolar disorder in full or partial remission, aged 18 to 50 years, who report moderate to severe cognitive difficulties, are recruited. Patients are randomized to receive weekly group-based cognitive remediation treatment over 12 weeks in addition to standard treatment or standard treatment alone. Both groups undergo neurocognitive testing and functional magnetic resonance imaging (fMRI) at baseline, post-treatment (week 12) and follow-up (week 26). The primary outcome is improved verbal memory, as measured with the Rey Auditory Verbal Learning Test (RAVLT) from baseline to post-treatment. With inclusion of 40 patients we obtain 86% power to detect a clinically relevant difference in verbal memory between groups. Secondary outcomes are improved attention, executive function and psychosocial function, as measured with the Rapid Visual Information Processing test, the Trail Making Test part B and the Functional Assessment Short Test (FAST), respectively. Tertiary outcomes are improved scores for additional neuropsychological tests of memory, attention, executive function and facial expression recognition, as well as in questionnaires measuring subjective cognitive difficulties, stress, coping strategies, personality traits, depressive symptoms and quality of life.
  
  
  CONCLUSIONS
  This is the first randomized controlled trial to evaluate the effects of cognitive remediation on cognitive function in patients with bipolar disorder who experience persistent cognitive difficulties despite being in full or partial remission.
  
  
  BACKGROUND
  ClinicalTrials.gov NCT01457235.
authors.affiliation: Copenhagen Affective Disorder Clinic, Psychiatric Centre Copenhagen, Copenhagen University Hospital, Rigshospitalet, Copenhagen, Denmark. kirsa.moerkeberg.demant@regionh.dk.
authors.forename: Kirsa M
authors.initials: KM
authors.lastname: Demant
authors.forename: Glennie Marie
authors.initials: GM
authors.lastname: Almer
authors.forename: Maj
authors.initials: M
authors.lastname: Vinberg
authors.forename: Lars Vedel
authors.initials: LV
authors.lastname: Kessing
authors.forename: Kamilla W
authors.initials: KW
authors.lastname: Miskowiak
mesh_terms: D000223:Adaptation, Psychological; D000293:Adolescent; D000328:Adult; D001288:Attention; D001714:Bipolar Disorder / Q000175:diagnosis / Q000523:psychology / Q000628:therapy*; D002985:Clinical Protocols; D003071:Cognition; D003072:Cognition Disorders / Q000175:diagnosis / Q000523:psychology / Q000628:therapy*; D015928:Cognitive Behavioral Therapy / Q000379:methods*; D003718:Denmark; D056344:Executive Function; D006801:Humans; D008279:Magnetic Resonance Imaging; D008568:Memory; D008875:Middle Aged; D011788:Quality of Life; D012074:Remission Induction; D012107:Research Design; D012720:Severity of Illness Index; D011795:Surveys and Questionnaires; D013997:Time Factors; D014145:Trail Making Test; D016896:Treatment Outcome; D055815:Young Adult