Abstract
BackgroundCognitive impairment is present in bipolar disorder (BD) during the acute and remitted phases and hampers functional recovery. However, there is currently no clinically available treatment with direct and lasting effects on cognitive impairment in BD. We will examine the effect of a novel form of cognitive remediation, action-based cognitive remediation (ABCR), on cognitive impairment in patients with BD, and explore the neural substrates of potential treatment efficacy on cognition.Methods/designThe trial has a randomized, controlled, parallel-group design. In total, 58 patients with BD in full or partial remission aged 18–55 years with objective cognitive impairment will be recruited. Participants are randomized to 10 weeks of ABCR or a control group. Assessments encompassing neuropsychological testing and mood ratings, and questionnaires on subjective cognitive complaints, psychosocial functioning, and quality of life are carried out at baseline, after 2 weeks of treatment, after the end of treatment, and at a six-month-follow-up after treatment completion. Functional magnetic resonance imaging scans are performed at baseline and 2 weeks into treatment. The primary outcome is a cognitive composite score spanning verbal memory, attention, and executive function. Two complete data sets for 52 patients will provide a power of 80% to detect a clinically relevant between-group difference on the primary outcome. Behavioral data will be analyzed using mixed models in SPSS while MRI data will be analyzed with the FMRIB Expert Analysis Tool (FEAT). Early treatment-related changes in neural activity from baseline to week 2 will be investigated for the dorsal prefrontal cortex and hippocampus as the regions of interest and with an exploratory whole-brain analysis.DiscussionThe results will provide insight into whether ABCR has beneficial effects on cognition and functioning in remitted patients with BD. The results will also provide insight into early changes in neural activity associated with improvement of cognition, which can aid future treatment development.Trial registrationClinicaltrials.gov, NCT03295305. Registered on 26 September 2017.
Highlights
Cognitive impairment is present in bipolar disorder (BD) during the acute and remitted phases and hampers functional recovery
The results will provide insight into early changes in neural activity associated with improvement of cognition, which can aid future treatment development
The present study investigates the effect of action-based cognitive remediation (ABCR) on cognitive improvement in clinically stable BD patients
Summary
The present study investigates the effect of ABCR on cognitive improvement in clinically stable BD patients. It explores early treatment effects on dorsal prefrontal activity to examine neurocircuitry target engagement. The criteria will serve to ensure that the sample is enriched for cognitive impairment, which will enhance the chances of detecting treatment-associated cognitive improvement [9] It could cause a recruitment challenge since it is estimated that 30–70% of euthymic patients with BD show clinically relevant objective cognitive impairment [1,2,3]. The pilot trial was conducted as a feasibility study and objective cognition was assessed using the SCIP-D rather than a full neuropsychological battery. Number Sequencing; WHODAS: World Health Organization Disability Assessment Schedule; WHOQOL: World Health Organization's Quality of Life Assessment; WSAS: Work and Social Adjustment Scale
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