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.


Journal

Schizophrenia bulletin
ISSN: 1745-1701
Titre abrégé: Schizophr Bull
Pays: United States
ID NLM: 0236760

Informations de publication

Date de publication:
03 05 2023
Historique:
medline: 4 5 2023
pubmed: 5 3 2023
entrez: 4 3 2023
Statut: ppublish

Résumé

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

Sections du résumé

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.

Identifiants

pubmed: 36869733
pii: 7069143
doi: 10.1093/schbul/sbac214
pmc: PMC10154711
doi:

Banques de données

ISRCTN
['ISRCTN14678860']

Types de publication

Randomized Controlled Trial Journal Article

Langues

eng

Sous-ensembles de citation

IM

Pagination

614-625

Subventions

Organisme : Department of Health
ID : IS-BRC-1215-20018
Pays : United Kingdom
Organisme : Department of Health
ID : NIHR-PGfAR RP-PG-0612-20002
Pays : United Kingdom
Organisme : Department of Health
ID : NF-SI-0514-10023
Pays : United Kingdom
Organisme : Department of Health
ID : NF-SI-0617-10120
Pays : United Kingdom

Informations de copyright

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

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Auteurs

Til Wykes (T)

Institute of Psychiatry, Psychology and Neuroscience, King's College London, London, UK.
South London and Maudsley NHS Foundation Trust, London, UK.

Dominic Stringer (D)

Institute of Psychiatry, Psychology and Neuroscience, King's College London, London, UK.

Janette Boadu (J)

Institute of Psychiatry, Psychology and Neuroscience, King's College London, London, UK.

Rose Tinch-Taylor (R)

Institute of Psychiatry, Psychology and Neuroscience, King's College London, London, UK.

Emese Csipke (E)

Institute of Psychiatry, Psychology and Neuroscience, King's College London, London, UK.

Matteo Cella (M)

Institute of Psychiatry, Psychology and Neuroscience, King's College London, London, UK.
South London and Maudsley NHS Foundation Trust, London, UK.

Andrew Pickles (A)

Institute of Psychiatry, Psychology and Neuroscience, King's College London, London, UK.

Paul McCrone (P)

School of Health Sciences, University of Greenwich, London, UK.

Clare Reeder (C)

Institute of Psychiatry, Psychology and Neuroscience, King's College London, London, UK.

Max Birchwood (M)

Warwick Medical School, University of Warwick, Coventry, UK.

David Fowler (D)

School of Psychology, University of Sussex, Brighton, UK.

Kathryn Greenwood (K)

School of Psychology, University of Sussex, Brighton, UK.

Sonia Johnson (S)

Faculty of Brain Sciences, University College London, London, UK.

Jesus Perez (J)

Cambridgeshire and Peterborough NHS Foundation Trust, Cambridge, UK.

Rosa Ritunnano (R)

Warwick Medical School, University of Warwick, Coventry, UK.

Andrew Thompson (A)

Warwick Medical School, University of Warwick, Coventry, UK.

Rachel Upthegrove (R)

School of Psychology, University of Birmingham, Birmingham, UK.

Jon Wilson (J)

Norfolk and Suffolk NHS Foundation Trust, Norwich, UK.

Alex Kenny (A)

Patient Advisory Board, King's College London, London, UK.

Iris Isok (I)

Patient Advisory Board, King's College London, London, UK.

Eileen M Joyce (EM)

UCL Queen Square Institute of Neurology, University College London, London, UK.

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