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Feasibility and pilot efficacy results from the multisite Cognitive Remediation in the Schizophrenia Trials Network
Richard S E Keefe1, Sophia Vinogradov, Alice Medalia
1Department of Psychiatry and Behavioral Sciences, Duke University Medical Center, Durham, NC 27710, USA. richard.keefe@duke.edu
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 (F(1,46) = 4.16, P = .047). At the end of treatment, a trend favoring cognitive remediation was not statistically significant (F(1,47) = 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.
Insights
Cognitive remediation is feasible in multisite schizophrenia trials. This approach, combining auditory training with bridging groups, showed preliminary cognitive benefits and high completion rates.
Area of Science:
- Neuroscience
- Psychiatry
- Clinical Psychology
Background:
- Pharmacologic interventions for schizophrenia may require cognitive enrichment for optimal benefit.
- Cognitive remediation exercises are crucial for stimulating neurocognitive potential in clinical trials.
- The feasibility of large-scale multisite studies incorporating cognitive remediation has not been established.
Purpose of the Study:
- To establish the feasibility of multisite clinical trials using cognitive remediation in schizophrenia patients.
- To assess enrollment, retention, and completion rates of cognitive remediation interventions in a clinical trial setting.
- To preliminarily evaluate the neurocognitive effects of cognitive remediation compared to a control condition.
Main Methods:
- 53 adult schizophrenia patients from 9 university sites were randomized to cognitive remediation (auditory training + NEAR bridging groups) or a control (computer games + healthy lifestyles groups).
- Participants engaged in 3-5 one-hour sessions weekly for up to 40 sessions or 12 weeks.
- Primary outcomes focused on feasibility: enrollment rate, retention, and completion of primary outcome measures.
Main Results:
- High feasibility was demonstrated with 53 of 54 projected patients enrolled and 77% completing the study.
- 31 patients completed all 40 sessions, and all participants completed primary outcome measures.
- Preliminary efficacy showed greater MATRICS Consensus Cognitive Battery composite score improvements in the cognitive remediation group after 20 sessions (P=.047).
Conclusions:
- Multisite clinical trials integrating cognitive remediation, specifically the Posit Science Brain Fitness program with NEAR bridging groups, are feasible at traditional clinical sites.
- The study supports the integration of cognitive remediation into clinical trial designs for schizophrenia.
- Cognitive remediation demonstrated preliminary positive effects on cognitive function in schizophrenia patients within a multisite trial framework.
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