Feasibility and pilot efficacy results from the multisite Cognitive Remediation in the Schizophrenia Trials Network (CRSTN) randomized controlled trial

Richard S.E. Keefe, Sophia Vinogradov, Alice Medalia, Peter F Buckley, Stanley N. Caroff, Deepak C. D'Souza, Phillip D. Harvey, Karen A. Graham, Robert M. Hamer, Stephen M. Marder, Del D. Miller, Stephen J. Olson, Jayendra K. Patel, Dawn Velligan, Trina M. Walker, Adam J. Haim, T. Scott Stroup

Research output: Contribution to journalArticle

48 Citations (Scopus)

Abstract

Background: The true benefit of pharmacologic intervention to improve cognition in schizophrenia may not be evident without regular cognitive enrichment. Clinical trials assessing the neurocognitive effects of new medications may require engagement in cognitive remediation exercises to stimulate the benefit potential. However, the feasibility of large-scale multisite studies using cognitive remediation at clinical trials sites has not been established. Method: 53 adult patients with DSM-IV schizophrenia from 9 university-affiliated sites were randomized to a cognitive remediation condition that included the Posit Science Brain Fitness auditory training program with weekly Neuropsychological and Educational Approach to Remediation (NEAR) "bridging groups" or a control condition of computer games and weekly healthy lifestyles groups. Patients were expected to complete 3 to 5 one-hour sessions weekly for 40 sessions or 12 weeks, whichever came first. The primary outcomes were feasibility results as measured by rate of enrollment, retention, and completion rate of primary outcome measures. The study was conducted from July 2009 through January 2010. Results: During a 3-month enrollment period, 53 (of a projected 54) patients were enrolled, and 41 (77%) met criteria for study completion. Thirty-one patients completed all 40 sessions, and all patients completed all primary outcome measures. Preliminary efficacy results indicated that, after 20 sessions, patients in the cognitive remediation condition demonstrated mean MATRICS Consensus Cognitive Battery composite score improvements that were 3.7 (95% CI, 0.05-7.34) T-score points greater than in patients in the computer-games control group (F1,46 = 4.16, P = .047). At the end of treatment, a trend favoring cognitive remediation was not statistically significant (F1,47 = 2.26, P = .14). Conclusion: Multisite clinical trials of cognitive remediation using the Posit Science Brain Fitness auditory training program with the NEAR method of weekly bridging groups at traditional clinical sites appear to be feasible. Trial Registration: ClinicalTrials.gov identifier: NCT00930150

Original languageEnglish (US)
Pages (from-to)1016-1022
Number of pages7
JournalJournal of Clinical Psychiatry
Volume73
Issue number7
DOIs
StatePublished - Jul 2012

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Schizophrenia
Randomized Controlled Trials
Video Games
Clinical Trials
Outcome Assessment (Health Care)
Education
Brain
Cognitive Remediation
Diagnostic and Statistical Manual of Mental Disorders
Cognition
Consensus
Exercise
Control Groups

ASJC Scopus subject areas

  • Psychiatry and Mental health

Cite this

Feasibility and pilot efficacy results from the multisite Cognitive Remediation in the Schizophrenia Trials Network (CRSTN) randomized controlled trial. / Keefe, Richard S.E.; Vinogradov, Sophia; Medalia, Alice; Buckley, Peter F; Caroff, Stanley N.; D'Souza, Deepak C.; Harvey, Phillip D.; Graham, Karen A.; Hamer, Robert M.; Marder, Stephen M.; Miller, Del D.; Olson, Stephen J.; Patel, Jayendra K.; Velligan, Dawn; Walker, Trina M.; Haim, Adam J.; Scott Stroup, T.

In: Journal of Clinical Psychiatry, Vol. 73, No. 7, 07.2012, p. 1016-1022.

Research output: Contribution to journalArticle

Keefe, RSE, Vinogradov, S, Medalia, A, Buckley, PF, Caroff, SN, D'Souza, DC, Harvey, PD, Graham, KA, Hamer, RM, Marder, SM, Miller, DD, Olson, SJ, Patel, JK, Velligan, D, Walker, TM, Haim, AJ & Scott Stroup, T 2012, 'Feasibility and pilot efficacy results from the multisite Cognitive Remediation in the Schizophrenia Trials Network (CRSTN) randomized controlled trial', Journal of Clinical Psychiatry, vol. 73, no. 7, pp. 1016-1022. https://doi.org/10.4088/JCP.11m07100
Keefe, Richard S.E. ; Vinogradov, Sophia ; Medalia, Alice ; Buckley, Peter F ; Caroff, Stanley N. ; D'Souza, Deepak C. ; Harvey, Phillip D. ; Graham, Karen A. ; Hamer, Robert M. ; Marder, Stephen M. ; Miller, Del D. ; Olson, Stephen J. ; Patel, Jayendra K. ; Velligan, Dawn ; Walker, Trina M. ; Haim, Adam J. ; Scott Stroup, T. / Feasibility and pilot efficacy results from the multisite Cognitive Remediation in the Schizophrenia Trials Network (CRSTN) randomized controlled trial. In: Journal of Clinical Psychiatry. 2012 ; Vol. 73, No. 7. pp. 1016-1022.
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abstract = "Background: The true benefit of pharmacologic intervention to improve cognition in schizophrenia may not be evident without regular cognitive enrichment. Clinical trials assessing the neurocognitive effects of new medications may require engagement in cognitive remediation exercises to stimulate the benefit potential. However, the feasibility of large-scale multisite studies using cognitive remediation at clinical trials sites has not been established. Method: 53 adult patients with DSM-IV schizophrenia from 9 university-affiliated sites were randomized to a cognitive remediation condition that included the Posit Science Brain Fitness auditory training program with weekly Neuropsychological and Educational Approach to Remediation (NEAR) {"}bridging groups{"} or a control condition of computer games and weekly healthy lifestyles groups. Patients were expected to complete 3 to 5 one-hour sessions weekly for 40 sessions or 12 weeks, whichever came first. The primary outcomes were feasibility results as measured by rate of enrollment, retention, and completion rate of primary outcome measures. The study was conducted from July 2009 through January 2010. Results: During a 3-month enrollment period, 53 (of a projected 54) patients were enrolled, and 41 (77{\%}) met criteria for study completion. Thirty-one patients completed all 40 sessions, and all patients completed all primary outcome measures. Preliminary efficacy results indicated that, after 20 sessions, patients in the cognitive remediation condition demonstrated mean MATRICS Consensus Cognitive Battery composite score improvements that were 3.7 (95{\%} CI, 0.05-7.34) T-score points greater than in patients in the computer-games control group (F1,46 = 4.16, P = .047). At the end of treatment, a trend favoring cognitive remediation was not statistically significant (F1,47 = 2.26, P = .14). Conclusion: Multisite clinical trials of cognitive remediation using the Posit Science Brain Fitness auditory training program with the NEAR method of weekly bridging groups at traditional clinical sites appear to be feasible. Trial Registration: ClinicalTrials.gov identifier: NCT00930150",
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T1 - Feasibility and pilot efficacy results from the multisite Cognitive Remediation in the Schizophrenia Trials Network (CRSTN) randomized controlled trial

AU - Keefe, Richard S.E.

AU - Vinogradov, Sophia

AU - Medalia, Alice

AU - Buckley, Peter F

AU - Caroff, Stanley N.

AU - D'Souza, Deepak C.

AU - Harvey, Phillip D.

AU - Graham, Karen A.

AU - Hamer, Robert M.

AU - Marder, Stephen M.

AU - Miller, Del D.

AU - Olson, Stephen J.

AU - Patel, Jayendra K.

AU - Velligan, Dawn

AU - Walker, Trina M.

AU - Haim, Adam J.

AU - Scott Stroup, T.

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N2 - Background: The true benefit of pharmacologic intervention to improve cognition in schizophrenia may not be evident without regular cognitive enrichment. Clinical trials assessing the neurocognitive effects of new medications may require engagement in cognitive remediation exercises to stimulate the benefit potential. However, the feasibility of large-scale multisite studies using cognitive remediation at clinical trials sites has not been established. Method: 53 adult patients with DSM-IV schizophrenia from 9 university-affiliated sites were randomized to a cognitive remediation condition that included the Posit Science Brain Fitness auditory training program with weekly Neuropsychological and Educational Approach to Remediation (NEAR) "bridging groups" or a control condition of computer games and weekly healthy lifestyles groups. Patients were expected to complete 3 to 5 one-hour sessions weekly for 40 sessions or 12 weeks, whichever came first. The primary outcomes were feasibility results as measured by rate of enrollment, retention, and completion rate of primary outcome measures. The study was conducted from July 2009 through January 2010. Results: During a 3-month enrollment period, 53 (of a projected 54) patients were enrolled, and 41 (77%) met criteria for study completion. Thirty-one patients completed all 40 sessions, and all patients completed all primary outcome measures. Preliminary efficacy results indicated that, after 20 sessions, patients in the cognitive remediation condition demonstrated mean MATRICS Consensus Cognitive Battery composite score improvements that were 3.7 (95% CI, 0.05-7.34) T-score points greater than in patients in the computer-games control group (F1,46 = 4.16, P = .047). At the end of treatment, a trend favoring cognitive remediation was not statistically significant (F1,47 = 2.26, P = .14). Conclusion: Multisite clinical trials of cognitive remediation using the Posit Science Brain Fitness auditory training program with the NEAR method of weekly bridging groups at traditional clinical sites appear to be feasible. Trial Registration: ClinicalTrials.gov identifier: NCT00930150

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