Trial Outcomes & Findings for Personalized and Scalable Cognitive Remediation Approaches (NCT NCT01945333)

Enrollment numbers are shown separately for phase 2 and phase 3 and summarized for the overall sample combined. Completion is shown for the combined sample. Participants from both phases are represented throughout the Participant Flow, Baseline Characteristics, Feasibility and Adverse Event modules. Other outcome measures include participants from phase 3 only.

Personalized and Scalable Cognitive Remediation Approaches

Feasibility is measured by enrollment, acceptability of randomization defined as number initiated allocated treatment, retention of subjects defined as number completed allocated treatment

Change in neurocognition is calculated as the difference in the MATRICS Consensus Cognitive Battery Neurocognitive Composite Score between baseline and treatment end-point (10 weeks). The MATRICS Consensus Cognitive Battery Neurocognitive Composite T-Score is a scaled score calculated from the following component subscales: a) working memory; b) attention/vigilance; c) verbal learning; d) visual learning; e) processing speed; f) reasoning and problem solving. The mean T-score is 50 with a standard deviation of 10. Higher scores on the scale mean better outcomes. Higher change scores mean better outcomes.

Change in neurocognition is calculated as the difference in the MATRICS Consensus Cognitive Battery Neurocognitive Composite Score between baseline and 3-month follow-up (5.5 to 6 months). The MATRICS Consensus Cognitive Battery Neurocognitive Composite T-Score is a scaled score calculated from the following component subscales: a) working memory; b) attention/vigilance; c) verbal learning; d) visual learning; e) processing speed; f) reasoning and problem solving. The mean T-score is 50 with a standard deviation of 10. Higher scores on the scale mean better outcomes. Higher change scores mean better outcomes.

Change in Tone Matching (percent correct) will be calculated as the difference between scores measured at baseline and treatment end-point (10 weeks), using pairs of 100-ms tones in series, with 500-ms inter-tone interval. The values on this scale range from 0% to 100% where higher scores mean better outcomes. Higher change scores mean better outcomes.

The UPSA - Brief is a proxy measure of daily functioning skills. Change from baseline to treatment end-point (10 weeks) will be assessed as the difference between the two scores. The scale score can range from 0 to 100. Higher scores mean better outcomes. Higher change scores mean better outcomes.

The SCI-PANSS is a semi-structured interview containing 30 items that assess symptoms of psychotic disorders including positive, negative and general psychopathology. Change from baseline to treatment end-point (10 weeks) will be assessed. Higher scores mean higher symptom severity. Change is calculated as the difference between the two scores. Greater change scores mean greater symptom improvement.

Intrinsic Motivation Inventory for Schizophrenia Research (IMI-SR), a 21 item 7-point Likert type scale designed to assess a participant's subjective experience of an activity, specifically in an experimental setting (e.g. "I enjoyed doing this activity very much"). The IMI-SR will be administered at the first and last treatment sessions.

The PCS consists of 4 items on a 7-point Likert-type scale that assess feelings of competency when performing computer-based learning activities, with higher scores indicating greater perceived competency. The PCS will be administered at the first and last treatment sessions.

Change in Tone Matching (percent correct) will be calculated as the difference in scores assessed at baseline and 3-month follow-up (5.5 to 6 months), using pairs of 100-ms tones in series, with 500-ms inter-tone interval. The values on this scale range from 0% to 100% where higher scores mean better outcomes. Greater change scores mean greater improvement.

The UPSA-Brief is a proxy measure for daily functioning skills. The scale score ranges from 0-100. Change from baseline to 3-month follow-up (5.5-6 months) will be assessed as the difference between the two scores. Higher scores mean better outcomes. Higher change scores mean better outcomes.

The SCI-PANSS is a semi-structured interview containing 30 items that assess symptoms of psychotic disorders including positive, negative and general psychopathology. Change from baseline to 3-month follow-up will be assessed.