Cognitive Remediation in Bipolar (CRiB2): a randomised trial assessing efficacy and mechanisms of cognitive remediation therapy compared to treatment as usual
People with bipolar disorder often struggle with memory, attention, and planning even when their mood is stable, and no evidence-based treatment currently exists for these cognitive problems. This trial will test whether a 12-week computerised cognitive remediation therapy (CRT) programme, delivered with a therapist, can improve day-to-day functioning in 250 adults with bipolar disorder compared to standard care alone. The problem is real: cognitive difficulties are a major driver of poor quality of life and reduced ability to work or manage daily tasks for people with bipolar disorder. A smaller pilot trial suggested CRT is feasible and promising, but was too small to prove efficacy. This larger, multi-site randomised controlled trial aims to provide a definitive answer. If CRT proves effective, it would be a breakthrough—the first psychological intervention shown to improve both cognitive and psychosocial functioning in bipolar disorder. That could directly reduce the burden for the many people whose daily lives are quietly constrained by these invisible cognitive deficits, potentially improving their ability to hold a job, manage finances, or maintain relationships. The trial also investigates *how* CRT works, by testing whether changes in cognition, stress hormones, mood fluctuations, or metacognitive skills drive the improvements.
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Research question: We will establish whether cognitive remediation therapy (CRT) provides meaningful benefits compared to treatment as usual (TAU) for people with bipolar disorders (BD). Background: People with BD experience difficulties with cognitive functioning, even outwith mood episodes, and these difficulties contribute markedly to problems in everyday functioning and quality of life. Although these impairments are important targets for intervention, evidence-based treatment is not available for clinical practice. CRT targets fundamental cognitive functions such as memory, attention, and executive functioning, and has been proven to improve these in people diagnosed with other psychoses. Preliminary evidence indicates significant potential for CRT to help people with BD. Our pilot randomised controlled trial (RCT; “CRiB1”) examined 60 people with BD randomised to receive an established 12-week CRT programme in addition to TAU, or TAU alone. The trial and intervention were both found to be feasible and acceptable; CRT was rated as desirable and led to improved cognitive and psychosocial functioning compared to TAU alone. However, CRiB1 was not powered to infer intervention efficacy. Aims: Our proposed Cognitive Remediation in Bipolar efficacy RCT (CRiB2) will determine whether CRT is efficacious in an adequately powered sample (N=250) of people with BD. The primary efficacy outcome is psychosocial functioning three months after the intervention endpoint (CRT+TAU versus TAU groups), i.e., six months after randomisation. CRiB2 also investigates CRT’s mechanism of action by examining factors that may mediate the relationship between CRT and the primary outcome. Methods: CRiB2 is a multisite, single-blind RCT comparing CRT+TAU (n=125) with TAU (n=125) for participants with BD, aged 18-65, not currently in an illness episode. The therapist-led computerised CRT programme (CIRCuiTS) is evidence-based on trials in psychotic illnesses. Data will be collected and analysed by investigators blinded to group allocation. After a baseline visit and randomisation (week 0), the participant will receive either CRT+TAU or TAU alone (weeks 1-12) and outcomes assessed at week 13 and 25 (primary outcome endpoint). We will also collect secondary outcomes including cognitive function (processing speed, attention, memory, verbal fluency, executive functioning, and a global cognitive composite measure), achievement of self-defined goals, self-rated cognitive difficulties, and quality of life. Primary and secondary outcomes will be compared between CRT+TAU with TAU groups via intention-to-treat analyses. We will assess whether CRT drives changes in global cognition, levels of cortisol, fluctuations in mood and metacognitive skills, and if these changes are associated with primary outcome changes in functioning (mediation effects). Timelines: The project duration is 3years + 5months; 250 participants will be randomised (by year2, month6), followed up (by year3) before data analysis and dissemination (project end). Potential impacts: Results will be reported in scientific and public domains. If efficacious, CRiB2 will represent a breakthrough by providing evidence of efficacy for a psychological intervention benefiting cognitive and psychosocial functioning in BD. This cognitive-enhancing therapy for BD would have the potential to markedly reduce burden for the many sufferers who experience deficits in functioning.
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