IntroductionCognitive dysfunction is common in bipolar disorder (BD) but is not sufficiently addressed by current treatments. Cognitive remediation (CR) may improve cognitive function in schizophrenia but no randomised controlled trial has investigated this intervention in BD. The present study aimed to investigate the effects of CR on persistent cognitive dysfunction in BD.MethodPatients with BD in partial remission with cognitive complaints were randomised to 12 weeks group-based CR (n=23) or standard treatment (ST) (n=23). Outcomes were improved verbal memory (primary), sustained attention, executive and psychosocial function (secondary) and additional measures of cognitive and psychosocial function (tertiary). Participants were assessed at baseline and weeks 12 and 26.ResultsOf the 46 randomised participants five dropped out and one was excluded after baseline. CR (n=18) had no effect on primary or secondary measures of cognitive or psychosocial function compared with ST (n=22). However, CR improved subjective sharpness at week 12, and quality of life and verbal fluency at week 26 follow-up (tertiary outcomes). Although the trial turned out to have suboptimal statistical power for the primary outcome analysis, calculation of the 95% confidence interval showed that it was highly unlikely that an increase in sample size would have rendered any beneficial effects of CR vs. ST on the verbal memory.ConclusionsShort-term group-based CR did not seem to improve overall cognitive or psychosocial function in individuals with BD in full or partial remission. The present findings suggest that that longer-term, more intensive and individualised CR may be necessary to improve cognition in BD.Trial RegistrationClinicalTrials.gov NCT01457235

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BackgroundA 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/DesignThe 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.DiscussionThis 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.Trial registrationClinicalTrials.gov NCT01457235.