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

Til Wykes; Dominic Stringer; Janette Boadu; Rose Tinch-Taylor; Emese Csipke; Matteo Cella; Andrew Pickles; Paul McCrone; Clare Reeder; Max Birchwood; David Fowler; Kathryn Greenwood; Sonia Johnson; Jesus Perez; Rosa Ritunnano; Andrew Thompson; Rachel Upthegrove; Jon Wilson; Alex Kenny; Iris Isok; Eileen M Joyce

doi:10.1093/schbul/sbac214

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

Til Wykes, Dominic Stringer, Janette Boadu, Rose Tinch-Taylor, Emese Csipke, Matteo Cella, Andrew Pickles, Paul McCrone, Clare Reeder, Max Birchwood, David Fowler, Kathryn Greenwood, Sonia Johnson, Jesus Perez, Rosa Ritunnano, Andrew Thompson, Rachel Upthegrove, Jon Wilson, Alex Kenny, Iris IsokEileen M Joyce

Research output: Contribution to journal › Article › peer-review

19 Citations (Scopus)

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/ISRCTN14678860 Now closed.

Original language	English
Pages (from-to)	614-625
Number of pages	12
Journal	Schizophrenia Bulletin
Volume	49
Issue number	3
Early online date	3 Mar 2023
DOIs	https://doi.org/10.1093/schbul/sbac214
Publication status	Published - May 2023

Keywords

Humans
Cognitive Remediation
Psychotic Disorders/therapy
Treatment Outcome
Cognition
Health Care Costs
Cost-Benefit Analysis

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10.1093/schbul/sbac214Licence: CC BY

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Wykes, T., Stringer, D., Boadu, J., Tinch-Taylor, R., Csipke, E., Cella, M., Pickles, A., McCrone, P., Reeder, C., Birchwood, M., Fowler, D., Greenwood, K., Johnson, S., Perez, J., Ritunnano, R., Thompson, A., Upthegrove, R., Wilson, J., Kenny, A., ... Joyce, E. M. (2023). 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. Schizophrenia Bulletin, 49(3), 614-625. https://doi.org/10.1093/schbul/sbac214

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title = "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/ISRCTN14678860 Now closed.",

keywords = "Humans, Cognitive Remediation, Psychotic Disorders/therapy, Treatment Outcome, Cognition, Health Care Costs, Cost-Benefit Analysis",

author = "Til Wykes and Dominic Stringer and Janette Boadu and Rose Tinch-Taylor and Emese Csipke and Matteo Cella and Andrew Pickles and Paul McCrone and Clare Reeder and Max Birchwood and David Fowler and Kathryn Greenwood and Sonia Johnson and Jesus Perez and Rosa Ritunnano and Andrew Thompson and Rachel Upthegrove and Jon Wilson and Alex Kenny and Iris Isok and Joyce, {Eileen M}",

note = "{\textcopyright} The Author(s) 2023. Published by Oxford University Press on behalf of the Maryland Psychiatric Research Center.",

year = "2023",

month = may,

doi = "10.1093/schbul/sbac214",

language = "English",

volume = "49",

pages = "614--625",

journal = "Schizophrenia Bulletin",

issn = "0586-7614",

publisher = "Oxford University Press",

number = "3",

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Wykes, T , Stringer, D, Boadu, J, Tinch-Taylor, R , Csipke, E , Cella, M , Pickles, A, McCrone, P, Reeder, C, Birchwood, M, Fowler, D, Greenwood, K, Johnson, S, Perez, J, Ritunnano, R, Thompson, A, Upthegrove, R, Wilson, J, Kenny, A, Isok, I & Joyce, EM 2023, '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', Schizophrenia Bulletin, vol. 49, no. 3, pp. 614-625. https://doi.org/10.1093/schbul/sbac214

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. / Wykes, Til ; Stringer, Dominic; Boadu, Janette et al.
In: Schizophrenia Bulletin, Vol. 49, No. 3, 05.2023, p. 614-625.

Research output: Contribution to journal › Article › peer-review

TY - JOUR

T1 - Cognitive Remediation Works But How Should We Provide It?

T2 - An Adaptive Randomized Controlled Trial of Delivery Methods Using a Patient Nominated Recovery Outcome in First-Episode Participants

AU - Wykes, Til

AU - Stringer, Dominic

AU - Boadu, Janette

AU - Tinch-Taylor, Rose

AU - Csipke, Emese

AU - Cella, Matteo

AU - Pickles, Andrew

AU - McCrone, Paul

AU - Reeder, Clare

AU - Birchwood, Max

AU - Fowler, David

AU - Greenwood, Kathryn

AU - Johnson, Sonia

AU - Perez, Jesus

AU - Ritunnano, Rosa

AU - Thompson, Andrew

AU - Upthegrove, Rachel

AU - Wilson, Jon

AU - Kenny, Alex

AU - Isok, Iris

AU - Joyce, Eileen M

PY - 2023/5

Y1 - 2023/5

N2 - 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/ISRCTN14678860 Now closed.

AB - 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/ISRCTN14678860 Now closed.

KW - Humans

KW - Cognitive Remediation

KW - Psychotic Disorders/therapy

KW - Treatment Outcome

KW - Cognition

KW - Health Care Costs

KW - Cost-Benefit Analysis

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AN - SCOPUS:85153483850

SN - 0586-7614

VL - 49

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JO - Schizophrenia Bulletin

JF - Schizophrenia Bulletin

IS - 3

ER -

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

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