TY - JOUR
T1 - Cognitive Remediation in Bipolar (CRiB2)
T2 - study protocol for a randomised controlled trial assessing efficacy and mechanisms of cognitive remediation therapy compared to treatment as usual
AU - Tsapekos, Dimosthenis
AU - Strawbridge, Rebecca
AU - Cella, Matteo
AU - Goldsmith, Kimberley
AU - Kalfas, Michail
AU - Taylor, Rosie
AU - Swidzinski, Sam
AU - Marwaha, Steven
AU - Grey, Libby
AU - Newton, Elizabeth
AU - Shackleton, Julie
AU - Harrison, Paul J.
AU - Browning, Michael D
AU - Harmer, Catherine J.
AU - Hartland, Hannah
AU - Cousins, David A.
AU - Barton, Stephen
AU - Wykes, Til
AU - Young, Allan H.
N1 - Funding Information:
This study is supported by the NIHR/Wellcome Trust King's and NIHR Oxford Clinical Research Facilities, NIHR Maudsley Biomedical Research Centre at South London and Maudsley NHS Foundation Trust and King's College London, and NIHR Oxford Health Biomedical Research Centre at Oxford Health NHS Foundation Trust. The views expressed are those of the author(s) and not necessarily those of the NHS, the NIHR or the Department of Health and Social Care. We would like to thank the clinical, academic, and administrative staff who support the study, including the King's Clinical Trials Unit, the CIRCuiTS team, and the Clinical Research Facilities at all sites. We would also like to thank our service user representatives, the NIHR FAST-R service, members of the NIHR Maudsley BRC SUAG, and members of the DMEC and the TSC for their contribution. Finally, we would like to express our gratitude to all participants, without whom this study would not have been possible.
Funding Information:
This study is supported by the NIHR/Wellcome Trust King's and NIHR Oxford Clinical Research Facilities, NIHR Maudsley Biomedical Research Centre at South London and Maudsley NHS Foundation Trust and King's College London, and NIHR Oxford Health Biomedical Research Centre at Oxford Health NHS Foundation Trust. The views expressed are those of the author(s) and not necessarily those of the NHS, the NIHR or the Department of Health and Social Care. We would like to thank the clinical, academic, and administrative staff who support the study, including the King's Clinical Trials Unit, the CIRCuiTS team, and the Clinical Research Facilities at all sites. We would also like to thank our service user representatives, the NIHR FAST-R service, members of the NIHR Maudsley BRC SUAG, and members of the DMEC and the TSC for their contribution. Finally, we would like to express our gratitude to all participants, without whom this study would not have been possible.
Funding Information:
During this study, AY (trial CI) has been the editor of Journal of Psychopharmacology and Deputy Editor for BJPsych Open. He has conducted paid lectures and advisory boards for AstraZeneca, Boehringer Ingelheim, Eli Lilly, Lundbeck, Sunovion, Servier, Livanova, Janssen, Allegan, Bionomics, Sumitomo Dainippon Pharma, COMPASS, Sage and Novartis and Neurocentrx. He is the Principal Investigator in the Restore-Life VNS registry study funded by LivaNova, ESKETINTRD3004: "An Open-label, Long-term, Safety and Efficacy Study of Intranasal Esketamine in Treatment-resistant Depression", "The Effects of Psilocybin on Cognitive Function in Healthy Participants" and "The Safety and Efficacy of Psilocybin in Participants with Treatment-Resistant Depression (P-TRD)". He is UK chief Investigator for Compass COMP006 & COMP007 studies, Novartis MDD study MIJ821A12201. He has received grant funding (past and present) from: NIMH (USA); CIHR (Canada); NARSAD (USA); Stanley Medical Research Institute (USA); MRC (UK); Wellcome Trust (UK); Royal College of Physicians (Edin); BMA (UK); UBC-VGH Foundation (Canada); WEDC (Canada); CCS Depression Research Fund (Canada); MSFHR (Canada); NIHR (UK). Janssen (UK), EU Horizon 2020. He has no shareholdings in pharmaceutical companies.
Publisher Copyright:
© 2023, The Author(s).
PY - 2023/12
Y1 - 2023/12
N2 - Background: 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 hours 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.Trial registration: Cognitive Remediation in Bipolar 2 (CRiB2): ISRCTN registry: https://www.isrctn.com/ ISRCTN10362331. Registered 04 May 2022. Overall trial status: Ongoing; Recruitment status: Recruiting.
AB - Background: 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 hours 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.Trial registration: Cognitive Remediation in Bipolar 2 (CRiB2): ISRCTN registry: https://www.isrctn.com/ ISRCTN10362331. Registered 04 May 2022. Overall trial status: Ongoing; Recruitment status: Recruiting.
KW - Bipolar disorder (BD)
KW - Cognitive remediation (CR)
KW - Efficacy
KW - Mechanisms
KW - Randomised controlled trial (RCT)
KW - Trial protocol
UR - http://www.scopus.com/inward/record.url?scp=85176561915&partnerID=8YFLogxK
U2 - 10.1186/s12888-023-05327-1
DO - 10.1186/s12888-023-05327-1
M3 - Article
C2 - 37968619
AN - SCOPUS:85176561915
SN - 1471-244X
VL - 23
JO - BMC Psychiatry
JF - BMC Psychiatry
IS - 1
M1 - 842
ER -
