An interventional study of Cognitive remediation in Schizophrenia and Schizoaffective Disorder, sponsored by New York State Psychiatric Institute. Completed at 5 sites in United States. Open to participants aged 18 Years to 65 Years. Per ClinicalTrials.gov, last updated 2026-07-17.
Sponsored by New York State Psychiatric Institute · Not applicable, Interventional, and Treatment
The purpose of this study is to develop and pilot test personalized and scalable approaches to Cognitive Remediation (CR) for schizophrenia and schizoaffective disorder. The intent is to more clearly define the therapeutic targets important to the facilitation of cognitive and functional improvement so that clinicians know how to customize cognitive interventions and deliver treatment in a more effective, efficient and personally relevant manner.
There are three phases of this study.
Phase 1: Development and Adaptation. The goal of this phase is to adapt currently used computer based CR approaches to make them more personalized and scalable. We will create two CR interventions which differ in choice and pacing of the cognitive exercises. This phase is complete.
Phase 2: Open Trial and Intervention Refinement. The goal of this phase is to obtain quantitative and qualitative feedback on the acceptability and usability of the interventions from participants to inform further refinement of the assessment and treatment packages. We will recruit ten subjects from an outpatient psychiatric rehabilitation program in New York City. After determining study eligibility, individuals will complete a standardized neuropsychological battery for schizophrenia assessment, and a 5-minute Tone Matching Test to assess basic auditory processing. Participants will be randomly assigned to receive one of two intervention packages, developed in Phase 1. Each session includes 60 minutes of computer-based learning activities and a 15 minute therapist-led discussion that links the computer activities to cognition as applied to daily tasks and recovery goals. Participants will complete a total of 10 sessions attending 2-3 times weekly for 5 weeks. During each session, participants will be asked to keep a log of software used. At the conclusion of this abbreviated trial, the participants will participate in focus groups in which they will be asked to provide verbal feedback on how enjoyable, engaging, and useful they perceived the computer and discussion based exercises to be. Participants will be asked to provide verbal feedback on the assessment procedures. CR clinicians will join the research team to discuss participants' engagement and their experience with administering the Tone Matching Test and interventions. Qualitative data summarized from participant logs and focus groups will be considered by the research team to refine the assessment battery, treatment parameters, and rubric of learning exercises. This phase is complete.
Phase 3: Pilot Feasibility Trial. People with a diagnosis of schizophrenia or schizoaffective disorder may be referred by their treating clinician or may respond to posted advertisements to inquire about study participation. After being informed of study procedures, interested individuals will be asked to sign a consent form that documents willingness to participate in this study. Following informed consent, participants will be asked questions about demographic characteristics (e.g. age, education, employment), medication and psychosocial treatment status, psychiatric symptoms and symptoms severity, and will complete a brief assessment of estimated Intelligence. Those with an Intelligence Quotient (IQ) estimate below 70 or meeting substance dependence criteria at the time of evaluation will be exited from the study. In the same or second assessment session, participants will complete assessments of neuropsychological ability, current functioning, and motivation for treatment. Participants will then be randomly assigned to one of two treatment conditions named "Brain Basics" or "Brain Exercises".
Each treatment condition is structured in a group format of up to 5 participants. Both treatments use commercially available computer-based training software to exercise cognitive skills such as speed of processing, attention, working memory, and verbal memory. Both conditions will entail 50 minutes on the computer and 10 minutes group discussion. In the discussion, participants review the cognitive activities they are working on and how they will help them achieve their recovery goals. The treatment phase will consist of 30 separate sessions each 60 minutes in duration, administered 3 times a week over the course of a 10-week period. Participants will be re-tested on outcome measures approximately 1 week following end of treatment, and again 3 months later.
3,471 studies on the registry are indexed under Schizophrenia; 472 are open to participants now.
This study's enrollment of 115 is above the median of 70 across 2,872 interventional studies indexed under Schizophrenia.
Browse Schizophrenia studies →New York State Psychiatric Institute is the lead sponsor of 425 studies on the registry; 26 are open to participants now.
Of its 50 completed or terminated interventional studies of FDA-regulated products, 45 (90%) have results posted.
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Exclusion Criteria:
Cognitive remediation includes sensory processing training
Behavioral: Cognitive remediation
Cognitive remediation includes sensory processing training
Behavioral: Cognitive remediation
Cognitive remediation does not include sensory processing training
Behavioral: Cognitive remediation
Cognitive remediation does not include sensory processing training
Behavioral: Cognitive remediation
Cognitive remediation sessions include working on computer based cognitive exercises and participating in a verbal discussion.
Feasibility of Enrollment, Randomization and Retention
Feasibility is measured by enrollment, acceptability of randomization defined as number initiated allocated treatment, retention of subjects defined as number completed allocated treatment
Time frame: Two years
Change in Neurocognition From Baseline to Treatment End-point
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.
Time frame: 10 weeks
Change in Neurocognition From Baseline to 3-month Follow-up
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.
Time frame: 5.5 to 6 months
Change in Tone Matching Ability From Baseline to Treatment End-point
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.
Time frame: 10 weeks
Change in UCSD Performance-Based Skills Assessment (UPSA)-Brief From Baseline to Treatment End-point
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.
Time frame: 10 weeks
Structured Clinical Interview for the Positive and Negative Syndrome Scale (SCI-PANSS) - Treatment End-point
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.
Time frame: 10 weeks
Intrinsic Motivation Inventory for Schizophrenia Research (IMI-SR)
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.
Time frame: 10 weeks
Perceived Competency Scale (PCS)
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.
Time frame: 10 weeks
Change in Tone Matching Ability From Baseline to 3-month Follow up
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.
Time frame: 5.5 to 6 months
Change in UCSD Performance-Based Skills Assessment (UPSA)-Brief From Baseline to 3-month Follow-up
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.
Time frame: 5.5 to 6 months
Structured Clinical Interview for the Positive and Negative Syndrome Scale (SCI-PANSS) - 3-month Follow-up
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.
Time frame: 5.5 to 6 months
| Milestone | Brain Basics for Impaired Tone Matchers | Brain Basics for Intact Tone Matchers | Brain Training for Impaired Tone Matcher | Brain Training for Intact Tone Matchers |
|---|---|---|---|---|
| Started | 32 | 23 | 29 | 31 |
| Started phase 2 | 4 | 2 | 4 | 2 |
| Started phase 3 | 28 | 21 | 25 | 29 |
| Completed | 22 | 17 | 20 | 20 |
| Not completed | 10 | 6 | 9 | 11 |
Feasibility is measured by enrollment, acceptability of randomization defined as number initiated allocated treatment, retention of subjects defined as number completed allocated treatment
| number of participants | Brain Basics for Impaired Tone Matchers | Brain Training for Impaired Tone Matchers | Brain Basics for Intact Tone Matchers | Brain Training for Intact Tone Matchers |
|---|---|---|---|---|
| Initiated allocated treatment | 32 | 29 | 23 | 31 |
| Completed allocated treatment | 22 | 20 | 17 | 20 |
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.
| units on a scale | Brain Basics for Impaired Tone Matchers | Brain Basics for Intact Tone Matchers | Brain Training for Impaired Tone Matcher | Brain Training for Intact Tone Matchers |
|---|---|---|---|---|
| Change in Neurocognition From Baseline to Treatment End-point | 6.1 ± 3.8 | 4.1 ± 5.5 | 3.9 ± 5.9 | 3.9 ± 4.2 |
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.
| units on a scale | Brain Basics for Impaired Tone Matchers | Brain Basics for Intact Tone Matchers | Brain Training for Impaired Tone Matcher | Brain Training for Intact Tone Matchers |
|---|---|---|---|---|
| Change in Neurocognition From Baseline to 3-month Follow-up | 7.6 ± 5.3 | 5.4 ± 4.9 | 4.9 ± 6.8 | 4.4 ± 6.7 |
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.
| score on a scale | Brain Basics for Impaired Tone Matchers | Brain Basics for Intact Tone Matchers | Brain Training for Impaired Tone Matcher | Brain Training for Intact Tone Matchers |
|---|---|---|---|---|
| Change in Tone Matching Ability From Baseline to Treatment End-point | 3.82 ± 7.6 | 1.67 ± 5.3 | 2.4 ± 7.7 | .20 ± 6.5 |
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.
| score on a scale | Brain Basics for Impaired Tone Matchers | Brain Basics for Intact Tone Matchers | Brain Training for Impaired Tone Matcher | Brain Training for Intact Tone Matchers |
|---|---|---|---|---|
| Change in UCSD Performance-Based Skills Assessment (UPSA)-Brief From Baseline to Treatment End-point | 12.1 ± 12.3 | 9.7 ± 10.4 | 6.8 ± 11.4 | 6.5 ± 12.4 |
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.
Results for this outcome have not been posted.
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.
Results for this outcome have not been posted.
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.
Results for this outcome have not been posted.
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.
| units on a scale | Brain Basics for Impaired Tone Matchers | Brain Basics for Intact Tone Matchers | Brain Training for Impaired Tone Matcher | Brain Training for Intact Tone Matchers |
|---|---|---|---|---|
| Change in Tone Matching Ability From Baseline to 3-month Follow up | 3.72 ± 5.28 | 1.99 ± 5.85 | 3.31 ± 8.38 | -2.28 ± 10.99 |
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.
| score on a scale | Brain Basics for Impaired Tone Matchers | Brain Basics for Intact Tone Matchers | Brain Training for Impaired Tone Matcher | Brain Training for Intact Tone Matchers |
|---|---|---|---|---|
| Change in UCSD Performance-Based Skills Assessment (UPSA)-Brief From Baseline to 3-month Follow-up | 17.2 ± 10.3 | 9.8 ± 14.7 | 15.2 ± 9.0 | 2.8 ± 17.5 |
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.
Results for this outcome have not been posted.
Collected over 6 months. Non-serious events are listed at a 0% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Brain Basics | 0/55 (0%) | 0/55 (0%) | 0/55 (0%) |
| Brain Training | 0/60 (0%) | 0/60 (0%) | 0/60 (0%) |
| Age, Continuous(years) | Brain Basics for Impaired Tone Matchers | Brain Basics for Intact Tone Matchers | Brain Training for Impaired Tone Matcher | Brain Training for Intact Tone Matchers | Total |
|---|---|---|---|---|---|
| Mean | 43.39 ± 11.04 | 41.9 ± 15.06 | 49.08 ± 10.08 | 37.52 ± 11.48 | 42.82 ± 12.44 |
| Sex: Female, Male(Participants) | Brain Basics for Impaired Tone Matchers | Brain Basics for Intact Tone Matchers | Brain Training for Impaired Tone Matcher | Brain Training for Intact Tone Matchers | Total |
|---|---|---|---|---|---|
| Female | 6 | 5 | 13 | 8 | 32 |
| Male | 26 | 18 | 16 | 23 | 83 |
| Ethnicity (NIH/OMB)(Participants) | Brain Basics for Impaired Tone Matchers | Brain Basics for Intact Tone Matchers | Brain Training for Impaired Tone Matcher | Brain Training for Intact Tone Matchers | Total |
|---|---|---|---|---|---|
| Hispanic or Latino | 10 | 7 | 9 | 13 | 39 |
| Not Hispanic or Latino | 22 | 16 | 20 | 18 | 76 |
| Unknown or Not Reported | 0 | 0 | 0 | 0 | 0 |
| Race (NIH/OMB)(Participants) | Brain Basics for Impaired Tone Matchers | Brain Basics for Intact Tone Matchers | Brain Training for Impaired Tone Matcher | Brain Training for Intact Tone Matchers | Total |
|---|---|---|---|---|---|
| American Indian or Alaska Native | 0 | 0 | 0 | 0 | 0 |
| Asian | 0 | 0 | 0 | 1 | 1 |
| Native Hawaiian or Other Pacific Islander | 0 | 0 | 0 | 0 | 0 |
| Black or African American | 22 | 9 | 18 | 13 | 62 |
| White | 10 | 13 | 10 | 17 | 50 |
| More than one race | 0 | 1 | 1 | 0 | 2 |
| Unknown or Not Reported | 0 | 0 | 0 | 0 | 0 |
| Region of Enrollment(participants) | Brain Basics for Impaired Tone Matchers | Brain Basics for Intact Tone Matchers | Brain Training for Impaired Tone Matcher | Brain Training for Intact Tone Matchers | Total |
|---|---|---|---|---|---|
| United States | 32 | 23 | 29 | 31 | 115 |
| Neurocognitive Composite T-Score(T score) | Brain Basics for Impaired Tone Matchers | Brain Basics for Intact Tone Matchers | Brain Training for Impaired Tone Matcher | Brain Training for Intact Tone Matchers | Total |
|---|---|---|---|---|---|
| Mean | 14.64 ± 8.90 | 26.29 ± 9.88 | 17.08 ± 11.57 | 23.93 ± 12.61 | 20.22 ± 11.74 |
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New York State Psychiatric Institute