| dc.contributor.author | Harrison, Paul J | |
| dc.contributor.author | Harmer, Catherine J | |
| dc.contributor.author | Browning, Michael | |
| dc.date.accessioned | 2024-01-03T14:59:41Z | |
| dc.date.available | 2024-01-03T14:59:41Z | |
| dc.date.issued | 2023-11 | |
| dc.identifier.citation | Dimosthenis Tsapekos, Rebecca Strawbridge, Matteo Cella, Kimberley Goldsmith, Michail Kalfas, Rosie H. Taylor, Samuel Swidzinski, Steven Marwaha, Libby Grey, Elizabeth Newton, Julie Shackleton, Paul J. Harrison, Michael Browning, Catherine Harmer, Hannah Hartland, David Cousins, Stephen Barton, Til Wykes & Allan H. Young. Cognitive Remediation in Bipolar (CRiB2): study protocol for a randomised controlled trial assessing efficacy and mechanisms of cognitive remediation therapy compared to treatment as usual. BMC Psychiatry 23, 842 (2023). | en |
| dc.identifier.uri | https://oxfordhealth-nhs.archive.knowledgearc.net/handle/123456789/1331 | |
| dc.description | Open Access This article is licensed under a Creative Commons Attribution 4.0 International License, which permits use, sharing, adaptation, distribution and reproduction in any medium or format, as long as you give appropriate credit to the original author(s) and the source, provide a link to the Creative Commons licence, and indicate if changes were made. The images or other third party material in this article are included in the article's Creative Commons licence, unless indicated otherwise in a credit line to the material. If material is not included in the article's Creative Commons licence and your intended use is not permitted by statutory regulation or exceeds the permitted use, you will need to obtain permission directly from the copyright holder. To view a copy of this licence, visit http://creativecommons.org/licenses/by/4.0/. The Creative Commons Public Domain Dedication waiver (http://creativecommons.org/publicdomain/zero/1.0/) applies to the data made available in this article, unless otherwise stated in a credit line to the data. | en |
| dc.description.abstract | A substantial proportion of people with bipolar disorder (BD) experience persistent cognitive difficulties associated with impairments in psychosocial functioning and a poorer disorder course. Emerging evidence suggests that cognitive remediation (CR), a psychological intervention with established efficacy in people with schizophrenia, can also benefit people with BD. Following a proof-of-concept trial showing that CR is feasible and potentially beneficial for people with BD, we are conducting an adequately powered trial in euthymic people with BD to 1) determine whether an individual, therapist-supported, computerised CR can reduce cognitive difficulties and improve functional outcomes; and 2) explore how CR exerts its effects.
Methods
CRiB2 is a two-arm, assessor-blind, multi-site, randomised controlled trial (RCT) comparing CR to treatment-as-usual (TAU). Participants are people with a diagnosis of BD, aged between 18 and 65, with no neurological or current substance use disorder, and currently euthymic. 250 participants will be recruited through primary, secondary, tertiary care, and the community. Participants will be block-randomised (1:1 ratio, stratified by site) to continue with their usual care (TAU) or receive a 12-week course of therapy and usual care (CR + TAU). The intervention comprises one-on-one CR sessions with a therapist supplemented with independent cognitive training for 30–40 h in total. Outcomes will be assessed at 13- and 25-weeks post-randomisation. Efficacy will be examined by intention-to-treat analyses estimating between-group differences in primary (i.e., psychosocial functioning at week 25 measured with the Functional Assessment Short Test) and secondary outcomes (i.e., measures of cognition, mood, patient-defined goals, and quality of life). Global cognition, metacognitive skills, affect fluctuation, and salivary cortisol levels will be evaluated as putative mechanisms of CR through mediation models.
Discussion
This study will provide a robust evaluation of efficacy of CR in people with BD and examine the putative mechanisms by which this therapy works. The findings will contribute to determining the clinical utility of CR and potential mechanisms of action. | en |
| dc.description.uri | https://doi.org/10.1186/s12888-023-05327 | en |
| dc.language.iso | en | en |
| dc.subject | Bipolar Disorder | en |
| dc.title | Cognitive Remediation in Bipolar (CRiB2): study protocol for a randomised controlled trial assessing efficacy and mechanisms of cognitive remediation therapy compared to treatment as usual | en |
| dc.type | Article | en |