Title: The Cognitive Remediation in Bipolar (CRiB) Study: A Feasibility Trial of Cognitive Remediation Therapy in People with Bipolar Disorder versus Treatment as Usual.
Funder: Department of Health and Social Care

Abstract: People with bipolar disorder often have cognitive deficits relative to matched controls, particularly in memory, attention and executive functions. These deficits persist during periods of full remission, limit recovery and are identified by service users and families as important treatment targets. However, there are few treatment options available. Similar cognitive deficits are found in people with a diagnosis of schizophrenia, and in this group, a treatment called Cognitive Remediation Therapy (CRT) is known to improve cognition and functional outcomes. We have therefore planned a clinical trial aimed at determining the practicability and preliminary efficacy of individual CRT for people with bipolar disorder recovering from a manic episode. After an initial assessment covering clinical history, mood symptomatology, cognitive abilities, and functional outcomes, 60 participants recruited from local services will be randomised to receive either treatment as usual (TAU), or a 12-week course of CRT plus TAU. CRT will comprise face-to-face sessions with a therapist, and computer-based training on a program called CiRcuiTs . At the end of the intervention, and at 12-week follow-up, all participants will repeat the assessment and complete additional feasibility questionnaires. Analyses will be conducted to examine the preliminary efficacy of CRT on cognition, social functioning, and symptoms. Furthermore, we will undertake a preliminary health economics analysis to ascertain the cost of delivering CRT in terms of staff and other resources. The results will allow us to plan a definitive RCT, for which we would hope to obtain research council funding.

Lay abstract: Bipolar disorder is a condition involving episodes of very low mood (known as depression ), problematically elevated mood ( mania ) and mixtures of both moods. It is common, complex, and costly, and has devastating impacts on relationships, work, and quality of life. In addition, it directly costs the NHS around &pound;340 million every year. The more episodes a person has, the more likely they are to relapse, and for quality of life to progressively fall. We need to find new treatments that improve recovery and boost resilience to reduce further episodes. People with bipolar disorder often have difficulty with thinking skills, such as concentration, memory, and planning. These problems are linked with reduced response to treatment, higher relapse rates, and more difficulties in everyday life. Similar problems in people diagnosed with schizophrenia can be helped with Cognitive Remediation Therapy (CRT). However, we don t yet know if CRT helps people with Bipolar. We have planned a study to examine this uncertainty. We will recruit 60 people recovering from mania, and randomly assign half to receive 12 weeks of CRT alongside their usual treatment, and half to their usual treatment only. We will then compare the two groups to see whether CRT is effective in improving thinking skills and everyday functioning, to obtain an idea of how large an effect is produced and whether benefits last after therapy finishes. We will also interview participants about their experience. The results will inform us how to best test CRT in a larger study.

Research activity codes: 6.6 PSYCHOLOGICAL AND BEHAVIOURAL
Health categories: MENTAL HEALTH