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


METHODS
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).


CONCLUSIONS
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.


BACKGROUND
ClinicalTrials.gov identifier: NCT00930150.
Department of Psychiatry and Behavioral Sciences, Duke University Medical Center, Durham, NC 27710, USA. richard.keefe@duke.edu
Richard S E
RS
Keefe
Sophia
S
Vinogradov
Alice
A
Medalia
Peter F
PF
Buckley
Stanley N
SN
Caroff
Deepak C
DC
D'Souza
Phillip D
PD
Harvey
Karen A
KA
Graham
Robert M
RM
Hamer
Stephen M
SM
Marder
Del D
DD
Miller
Stephen J
SJ
Olson
Jayendra K
JK
Patel
Dawn
D
Velligan
Trina M
TM
Walker
Adam J
AJ
Haim
T Scott
TS
Stroup
D000328:Adult; D003072:Cognition Disorders / Q000175:diagnosis / Q000523:psychology / Q000628:therapy*; D003194:Computer-Assisted Instruction; D004311:Double-Blind Method; D055317:Evidence-Based Practice; D005240:Feasibility Studies; D005260:Female; D006801:Humans; D007318:Inservice Training; D008297:Male; D008875:Middle Aged; D009483:Neuropsychological Tests; D010865:Pilot Projects; D011618:Psychotic Disorders / Q000175:diagnosis / Q000523:psychology / Q000628:therapy*; D012073:Remedial Teaching; D012559:Schizophrenia / Q000175:diagnosis / Q000628:therapy*; D012565:Schizophrenic Psychology; D016896:Treatment Outcome