Cognitive Remediation Works But How Should We Provide It? An Adaptive Randomized Controlled Trial of Delivery Methods Using a Patient Nominated Recovery Outcome in First-Episode Participants

Abstract

Background and hypothesis: Cognitive remediation (CR) benefits cognition and functioning in psychosis but we do not know the optimal level of therapist contact, so we evaluated the potential benefits of different CR modes.

Study design: A multi-arm, multi-center, single-blinded, adaptive trial of therapist-supported CR. Participants from 11 NHS early intervention psychosis services were independently randomized to Independent, Group, One-to-One, or Treatment-as-usual (TAU). The primary outcome was functional recovery (Goal Attainment Scale [GAS]) at 15-weeks post randomization. Independent and TAU arms were closed after an interim analysis, and three informative contrasts tested (Group vs One-to-One, Independent vs TAU, Group + One-to-One vs TAU). Health economic analyses considered the cost per Quality Adjusted Life Year (QALY). All analyses used intention-to-treat principles.

Study results: We analyzed 377 participants (65 Independent, 134 Group, 112 One-to-One, 66 TAU). GAS did not differ for Group vs One-to-One: Cohen's d: 0.07, -0.25 to 0.40 95% CI, P = .655; Independent vs TAU: Cohen's d: 0.07, -0.41 to 0.55 95% CI, P = .777. GAS and the cognitive score improved for Group + One-to-One vs TAU favoring CR (GAS: Cohen's d: 0.57, 0.19-0.96 95% CI, P = .003; Cognitive score: Cohens d: 0.28, 0.07-0.48 95% CI, P = .008). The QALY costs were £4306 for Group vs TAU and £3170 for One-to-One vs TAU. Adverse events did not differ between treatment methods and no serious adverse events were related to treatment.

Conclusions: Both active therapist methods provided cost-effective treatment benefiting functional recovery in early psychosis and should be adopted within services. Some individuals benefited more than others so needs further investigation.

Trial registration: ISRCTN14678860 https://doi.org/10.1186/ISRCTN14678860Now closed.

Keywords: cognitive training; early intervention; functioning; goal achievement; therapist support.

Conflict of interest statement

Prof Wykes and Dr Reeder developed the cognitive remediation software, CIRCuiTS, used in this study. No other authors have any conflict of interest to report.

Funding/Support: This study is funded by the National Institute for Health Research (NIHR) Programme grant for Applied Research (NIHR-PGfAR RP-PG-0612-20002).

Author contributions: Wykes, Joyce, Pickles, and McCrone had full access to all the data in the study and take responsibility for the integrity of the data and the accuracy of the data analysis.

Concept and design: Wykes, Joyce, Pickles, and McCrone.

Drafting the manuscript: Wykes, Joyce, Pickles, McCrone, Boadu, Stringer, Tinch-Taylor, Cella, and Csipke.

Critical revision of the manuscript for important intellectual content: All authors.

Statistical and health economic analysis: Pickles, Stringer, Tinch-Taylor, McCrone, and Boadu.

Obtained funding: Wykes, Joyce, Pickles, McCrone, Reeder, Birchwood, Fowler, Johnson, and Perez.

Administrative, technical, or material support: KCL CTU.

Supervision: Wykes and Joyce.

Role of the Funder/Sponsor: The funder had no role in the design and conduct of the study, collection, management, analysis, and interpretation of the data; preparation, review, or approval of the manuscript; and decision to submit the manuscript for publication.

Data Sharing Statement: See supplement.

Additional Contributions: We would like to thank all the research assistants and therapists who helped us to recruit and treat participants in this trial. We would also like to acknowledge Tiyi Morris who carried out the interim health economic analysis and Andrew Watson, Tjasa Velikonja and Leena Subramanian who provided coordination at various times. The UK Clinical Research Collaboration-registered King’s Clinical Trials Unit at King’s Health Partners, which is part funded by the NIHR Biomedical Research Centre for Mental Health at South London and Maudsley NHS Foundation Trust and King’s College London and the NIHR Evaluation, Trials and Studies Coordinating Centre supported our randomization. Most importantly, vital support was provided by our Patient Advisory Board and the independent Data Monitoring Committee who both had input into each stage of the study.

© The Author(s) 2023. Published by Oxford University Press on behalf of the Maryland Psychiatric Research Center.

Figures

Fig. 1.

Consort flow chart.

Fig. 2.

Forest plots for primary and secondary results at each of the contrasts for the 3-month post therapy and 6-month follow-up time points.