Henry W Mahncke1, Sarah-Jane Kim2, Annika Rose2, Catherine Stasio2, Peter Buckley3, Stanley Caroff4, Erica Duncan5, Sarah Yasmin6, L Fredrik Jarskog7, J Steven Lamberti8, Keith Nuechterlein9, Martin Strassnig10, Dawn Velligan11, Joseph Ventura9, Trina Walker12, T Scott Stroup13, Richard S E Keefe12. 1. Posit Science, United States of America. Electronic address: henry.mahncke@positscience.com. 2. Posit Science, United States of America. 3. Virginia Commonwealth University, United States of America. 4. Corporal Michael J. Crescenz VA Medical Center, The Perelman School of Medicine, University of Pennsylvania, United States of America. 5. Atlanta Veterans Affairs Medical Center, Emory University, United States of America. 6. Palo Alto Veterans Affairs Medical Center, United States of America. 7. University of North Carolina at Chapel Hill, United States of America. 8. University of Rochester, United States of America. 9. University of California, Los Angeles, United States of America. 10. University of Miami, United States of America. 11. University of Texas Health Science Center in Austin, United States of America. 12. Duke University, United States of America. 13. Columbia University, United States of America.
Abstract
OBJECTIVE: Cognitive impairment in schizophrenia is a core feature of the disorder. Computerized cognitive training has shown promise in pilot studies. A 26-week randomized blinded placebo-controlled trial was conducted to investigate the effect of a novel computerized cognitive training program on cognitive and functional capacity outcomes. METHOD: The study followed MATRICS guidelines for the evaluation of interventions designed to improve cognitive function in schizophrenia. Participants (N = 150) were randomized to experimental (computerized cognitive training in a game-like format) or active control (computer games) groups. Training was conducted in-clinic, with an intended training schedule of 5 days per week, 1 h per day, for 26 weeks. Co-primary outcome measures were the MATRICS Consensus Cognitive Battery (MCCB) composite score and the UCSD Performance-Based Skills Assessment (UPSA-2) total score, secondary outcome measures included the Cognitive Assessment Interview (CAI) and the Short-Form-12 Mental Composite Score (SF-12 MCS). Target engagement was assessed with task-learning based assessment. RESULTS: At baseline, the groups were well matched. No significant effect of the experimental treatment was seen on the primary or secondary outcome measures compared to the active control. Review of the task learning/target engagement data suggested inadequate target engagement. CONCLUSIONS: Results do not support a cognitive or functional capacity benefit from this implementation of a computerized cognitive training program in people with schizophrenia. In future trials, careful consideration is merited of the assessment of task learning/target engagement, the effects of making the cognitive training game-like on motivation, and the implicit effects of trial requirements on participant selection.
RCT Entities:
OBJECTIVE:Cognitive impairment in schizophrenia is a core feature of the disorder. Computerized cognitive training has shown promise in pilot studies. A 26-week randomized blinded placebo-controlled trial was conducted to investigate the effect of a novel computerized cognitive training program on cognitive and functional capacity outcomes. METHOD: The study followed MATRICS guidelines for the evaluation of interventions designed to improve cognitive function in schizophrenia. Participants (N = 150) were randomized to experimental (computerized cognitive training in a game-like format) or active control (computer games) groups. Training was conducted in-clinic, with an intended training schedule of 5 days per week, 1 h per day, for 26 weeks. Co-primary outcome measures were the MATRICS Consensus Cognitive Battery (MCCB) composite score and the UCSD Performance-Based Skills Assessment (UPSA-2) total score, secondary outcome measures included the Cognitive Assessment Interview (CAI) and the Short-Form-12 Mental Composite Score (SF-12 MCS). Target engagement was assessed with task-learning based assessment. RESULTS: At baseline, the groups were well matched. No significant effect of the experimental treatment was seen on the primary or secondary outcome measures compared to the active control. Review of the task learning/target engagement data suggested inadequate target engagement. CONCLUSIONS: Results do not support a cognitive or functional capacity benefit from this implementation of a computerized cognitive training program in people with schizophrenia. In future trials, careful consideration is merited of the assessment of task learning/target engagement, the effects of making the cognitive training game-like on motivation, and the implicit effects of trial requirements on participant selection.
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