SchizophreniaMini-COTESNCT03079024
Minnesota Community-Based Cognitive Training in Early Psychosis
A study testing Targeted Cognitive Training, General Cognitive Exercises and Coordinated Specialty Care for First Episode Psychosis in people with Schizophrenia and Psychosis, run by University of Minnesota at 1 site in United States.
Trial summary
The purpose of this study is to determine whether cognitive training exercises can improve cognitive functioning in young patients with recent-onset psychosis who are being treated in community mental health settings using the NAVIGATE model. Read more about this study
- Who is it for?
- Ages 16 to 35 years
- Conditions the study is for
- Schizophrenia, Psychosis, Schizoaffective Disorder
- What is being tested?
- Targeted Cognitive Training, General Cognitive Exercises and Coordinated Specialty Care for First Episode Psychosis
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 45 participants
- Where
- 1 siteUnited States
- Study dates
- 19 May 2017to 26 Mar 2022
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 16 to 35 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- Clinical diagnosis of schizophrenia, schizoaffective disorder, schizophreniform disorder, major depressive disorder with psychotic features, bipolar disorder with psychotic features, psychosis disorder not otherwise specified, or unspecified schizophrenia spectrum disorder, and started receiving treatment services at a First Episode Psychosis Program within the last two years
- Good general physical health
- Aged between 16 and 35 years (inclusive)
- Fluent in spoken and written English
- No neurological disorder (diagnosis of Autism Spectrum Disorder is allowed)
- Achieved clinical stability, defined as outpatient status for at least one month prior to study participation, stable doses of psychiatric medications for at least one month prior to study participation
- Women who are pregnant or breastfeeding may participate in this study.
Who cannot join
- Unable to provide informed consent
- Participated in significant cognitive training programs within the last three years
- Clinically significant substance abuse that is impeding the subject's ability to participate fully during recruitment, assessment, or training (is unable to remain sober for assessments and training).
- Prescribed >0.5mg daily benztropine (Congentin), >25mg daily diphenhydramine, or high doses of clozapine (>500 mg po qd) or olanzapine (to be determined on a case by case basis).
- Active suicidal ideation at screening or baseline, or previous intent to act on suicidal ideation with a specific plan, preparatory acts, or an actual suicide attempt within the last 6 months, as indicated by the C-SSRS
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Minnesota, Dept of Psychiatry
Minneapolis, Minnesota, 55116
About this study
The purpose of this study is to determine whether cognitive training exercises can improve cognitive functioning in young patients with recent-onset psychosis who are being treated in community mental health settings using the NAVIGATE model. The investigators will examine the effects of web-based cognitive training exercises delivered on iPads. Participants will be randomized to one of three conditions, and will be assessed at Baseline, Post-Intervention, and 6 Month Follow Up on measures of clinical, neurocognitive, and functional status.
Read the detailed description
The purpose of this study is to perform a double-blind randomized controlled trial (RCT) in young patients with First Episode Psychosis (FEP) to target improvement in cognitive functioning within real-world treatment settings. This study will be performed in the University of Minnesota Department of Psychiatry; patients will be recruited from local community based mental health care settings that implement a NAVIGATE model for FEP.
All participants will undergo baseline assessment in measures of clinical, neurocognitive, and functional status prior to randomization. Participants will be equally randomized to one of three groups: Targeted Cognitive Training (TCT); General Cognitive Exercises (GCE); or Treatment as Usual (TAU). Participants assigned to a cognitive training group will be loaned an iPad to complete study training at home. They will complete 60 minutes of training 5 times a week over the course of 6 weeks for a total of 30 hours of training. Participants will be allowed up to 12 weeks to complete the full 30 hours. Participants will return after 30 hours of training or 12 weeks, whichever comes first, for Post-Intervention Assessments. Then participants will enter a no-contact follow up period, until it is time for their 6 Month Follow Up assessment.
Specific Aims:
- Perform a double-blind RCT of web-based, portable computerized cognitive training in young individuals with recent onset psychosis receiving treatment within the University of Minnesota, Department of Psychiatry's First Episode Psychosis Program or other state clinics utilizing the NAVIGATE treatment model.
- Compare the clinical and cognitive effects of neural system-informed TCT that focuses explicitly and specifically on distributed neural system efficiency in auditory/verbal and social cognitive domains, vs. more non-specific GCE designed to enhance executive functioning and problem-solving, vs. TAU. Determine the durability of these effects and their relationship to functional outcome over a 6 month period.
- As a secondary aim, investigate the feasibility, tolerability, and acceptability of the intervention by service providers, clients, and caregivers in these real-world treatment centers.
Hypotheses to be tested:
- TCT subjects will show significantly greater gains in general cognition, verbal learning/memory, and social cognition compared to GCE and TAU subjects. These gains in the TCT group will be sustained at 6-month follow-up.
- GCE subjects will show improvement in problem-solving and global cognition compared to TAU subjects. At 6 month follow-up, GCE subjects will show lower gains in global cognition and verbal learning/memory than TCT subjects.
- Gains in general cognition and processing speed, and in social cognition in TCT subjects will correlate with improvements on 6-month measures of occupational and social functioning, respectively, as well as internalized stigma. These associations will be significantly greater in TCT subjects vs. GCE or TAU subjects.
- Symptom ratings will show improvement in all subject groups at 6 months, with no significant between-group differences.
- At least 70% of randomized clients will complete >20 hours of training in the TCT and GCE arms.
- Participants and clinicians will rate the TCT and GCE interventions as equally feasible, tolerable, and acceptable.
Participants from this study will also be recruited to participate in an adjunct protocol conducted by Dr. Sophia Vinogradov, titled "Is cognitive training neuroprotective in early psychosis?" NCT03049800.
Data from this project will be analysed with a sister protocol conducted by Dr. Rachel Loewy at the University of California San Francisco, titled "Community-Based Cognitive Training in Early Schizophrenia (COTES)," NCT01973270.
- Conditions
- Schizophrenia, Psychosis, Schizoaffective Disorder, Schizophreniform Disorders, Psychosis NOS, Depression Psychotic Feature
- Being tested
- Targeted Cognitive Training, General Cognitive Exercises, Coordinated Specialty Care for First Episode Psychosis
- Keywords
- Cognitive Training, First Episode Psychosis, Recent Onset Psychosis
- Medical subject headings
- Schizophrenia, Psychotic Disorders, Mental Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Targeted Cognitive TrainingDevice
- Auditory Training Module (20 hours): exercises designed to improve speed and accuracy of auditory processing while engaging working memory and cognitive control. Exercises adjust difficulty level to maintain an ~80% correct performance. Exercises contain stimuli spanning the acoustic organization of speech. In the initial stages, stimuli exaggerate the rapid temporal transitions by increasing amplitude and stretching in time. The exaggeration is gradually removed so that by the end, all stimuli have characteristics representative of real-world speech.
- Social Cognition Module (10 hours): exercises designed to improve core deficits of social cognition in psychosis. Exercises apply principles of implicit learning to restore capacity to process and utilize socially-relevant information, and includes training to improve perception of affect (visual/vocal) and social cues (faces, gazes, social situations), theory of mind, self-referential style, emotion labeling and working memory.
General Cognitive ExercisesDevice
The GCE will focus on executive dysfunction, as this domain is a significant, functionally important area of deficit in schizophrenia and has been the target of many previous studies. We will train this domain using a suite of engaging, adaptive web-based exercises that target executive function, intelligence, and spatial navigation developed by Posit Science. The exercises will be provide engaging, adaptive training as described in the Targeted Cognitive Training.
Coordinated Specialty Care for First Episode PsychosisOther
Individuals in this study are receiving care from a coordinated specialty care clinic (CSC) for first episode psychosis. These clinics are following the NAVIGATE treatment model for early psychosis.
| Study group | Role | What they receive |
|---|---|---|
| Targeted Cognitive Training (TCT) | Experimental | Neuroadaptive Cognitive Training Receives: Device: Targeted Cognitive Training; Other: Coordinated Specialty Care for First Episode Psychosis |
| General Cognitive Exercises (GCE) | Experimental | Neuroadaptive cognitive training Receives: Device: General Cognitive Exercises; Other: Coordinated Specialty Care for First Episode Psychosis |
| Treatment as Usual (TAU) | Active comparator | Treatment as Usual Receives: Other: Coordinated Specialty Care for First Episode Psychosis |
What is being measured
The primary outcome is the main question the study is designed to answer.
Speed of Processing From the Measurement and Treatment Research to Improve Cognition in Schizophrenia (MATRICS) Consensus Cognitive Battery (MCCB)
A composite T-score of:
- Symbol Coding from the Brief Assessment of Cognition in Schizophrenia (BACS): Symbol Coding. Timed paper-and-pencil test in which respondent uses a key to write digits that correspond to nonsense symbols.
- Category Fluency: Animal Naming: Oral test in which respondent names as many animals as she/he can in 1 minute.
- Trail Making Test: Part A: Timed paper-and-pencil test in which respondent draws a line to connect consecutively numbered circles placed irregularly on a sheet of paper. The composite T-score is the average T-score across the 3 measures. T-scores range from 0-100, with higher T-scores corresponding to better performance. A T- score of 50 indicates the population mean (average) with a standard deviation of
10.
Measured: baseline
Speed of Processing From the Measurement and Treatment Research to Improve Cognition in Schizophrenia (MATRICS) Consensus Cognitive Battery (MCCB)
A composite T-score of:
- Symbol Coding from the Brief Assessment of Cognition in Schizophrenia (BACS): Symbol Coding. Timed paper-and-pencil test in which respondent uses a key to write digits that correspond to nonsense symbols.
- Category Fluency: Animal Naming: Oral test in which respondent names as many animals as she/he can in 1 minute.
- Trail Making Test: Part A: Timed paper-and-pencil test in which respondent draws a line to connect consecutively numbered circles placed irregularly on a sheet of paper. The composite T-score is the average T-score across the 3 measures. T-scores range from 0-100, with higher T-scores corresponding to better performance. A T- score of 50 indicates the population mean (average) with a standard deviation of
10.
Measured: 6 weeks
Speed of Processing From the Measurement and Treatment Research to Improve Cognition in Schizophrenia (MATRICS) Consensus Cognitive Battery (MCCB)
A composite T-score of:
- Symbol Coding from the Brief Assessment of Cognition in Schizophrenia (BACS): Symbol Coding. Timed paper-and-pencil test in which respondent uses a key to write digits that correspond to nonsense symbols.
- Category Fluency: Animal Naming: Oral test in which respondent names as many animals as she/he can in 1 minute.
- Trail Making Test: Part A: Timed paper-and-pencil test in which respondent draws a line to connect consecutively numbered circles placed irregularly on a sheet of paper. The composite T-score is the average T-score across the 3 measures. T-scores range from 0-100, with higher T-scores corresponding to better performance. A T- score of 50 indicates the population mean (average) with a standard deviation of
10.
Measured: 6 months followup
Attention From the Measurement and Treatment Research to Improve Cognition in Schizophrenia (MATRICS) Consensus Cognitive Battery (MCCB)
Continuous Performance Test-Identical Pairs (CPT-IP): A computer- administered measure of sustained attention in which respondent presses a response button to consecutive matching numbers. T-scores range from 0-100, with higher T-scores corresponding to better performance. A T-score of 50 indicates the population mean (average) with a standard deviation of 10.
Measured: baseline
Attention From the Measurement and Treatment Research to Improve Cognition in Schizophrenia (MATRICS) Consensus Cognitive Battery (MCCB)
Continuous Performance Test-Identical Pairs (CPT-IP): A computer- administered measure of sustained attention in which respondent presses a response button to consecutive matching numbers. T-scores range from 0-100, with higher T-scores corresponding to better performance. A T-score of 50 indicates the population mean (average) with a standard deviation of 10.
Measured: 6 weeks
Attention From the Measurement and Treatment Research to Improve Cognition in Schizophrenia (MATRICS) Consensus Cognitive Battery (MCCB)
Continuous Performance Test-Identical Pairs (CPT-IP): A computer- administered measure of sustained attention in which respondent presses a response button to consecutive matching numbers. T-scores range from 0-100, with higher T-scores corresponding to better performance. A T-score of 50 indicates the population mean (average) with a standard deviation of 10.
Measured: 6 months followup
Working Memory From the Measurement and Treatment Research to Improve Cognition in Schizophrenia (MATRICS) Consensus Cognitive Battery (MCCB)
Verbal and Visual Working Memory: A composite score of the Letter- Number Span test and the Spatial Span test from the Wechsler Memory Scale®-3rd Ed. (WMS®-III). Letter-Number Span: An orally administered test in which respondent mentally reorders strings of number and letters and repeats them to administrator. Spatial Span: Using a board on which 10 cubes are irregularly spaced, respondent taps cubes in same (or reverse) sequence as test administrator. The composite T-score is the average T-score across the 2 measures. T-scores range from 0-100, with higher T-scores corresponding to better performance. A T-score of 50 indicates the population mean (average) with a standard deviation of 10.
Measured: Basline
Working Memory From the Measurement and Treatment Research to Improve Cognition in Schizophrenia (MATRICS) Consensus Cognitive Battery (MCCB)
Verbal and Visual Working Memory: A composite score of the Letter- Number Span test and the Spatial Span test from the Wechsler Memory Scale®-3rd Ed. (WMS®-III). Letter-Number Span: An orally administered test in which respondent mentally reorders strings of number and letters and repeats them to administrator. Spatial Span: Using a board on which 10 cubes are irregularly spaced, respondent taps cubes in same (or reverse) sequence as test administrator. The composite T-score is the average T-score across the 2 measures. T-scores range from 0-100, with higher T-scores corresponding to better performance. A T-score of 50 indicates the population mean (average) with a standard deviation of 10.
Measured: 6 weeks
Working Memory From the Measurement and Treatment Research to Improve Cognition in Schizophrenia (MATRICS) Consensus Cognitive Battery (MCCB)
Verbal and Visual Working Memory: A composite score of the Letter- Number Span test and the Spatial Span test from the Wechsler Memory Scale®-3rd Ed. (WMS®-III). Letter-Number Span: An orally administered test in which respondent mentally reorders strings of number and letters and repeats them to administrator. Spatial Span: Using a board on which 10 cubes are irregularly spaced, respondent taps cubes in same (or reverse) sequence as test administrator. The composite T-score is the average T-score across the 2 measures. T-scores range from 0-100, with higher T-scores corresponding to better performance. A T-score of 50 indicates the population mean (average) with a standard deviation of 10.
Measured: 6 months followup
Verbal Learning From the Measurement and Treatment Research to Improve Cognition in Schizophrenia (MATRICS) Consensus Cognitive Battery (MCCB)
Hopkins Verbal Learning Test-Revised (HVLT-R): An orally
administered test in which a list of 12 words from three taxonomic categories is presented and the respondent is asked to recall as many as possible after each of three learning trials. T-scores range from 0-100, with higher T-scores corresponding to better performance. A T-score of 50 indicates the population mean (average) with a standard deviation of 10.
Measured: Baseline
Verbal Learning From the Measurement and Treatment Research to Improve Cognition in Schizophrenia (MATRICS) Consensus Cognitive Battery (MCCB)
Hopkins Verbal Learning Test-Revised (HVLT-R): An orally
administered test in which a list of 12 words from three taxonomic categories is presented and the respondent is asked to recall as many as possible after each of three learning trials. T-scores range from 0-100, with higher T-scores corresponding to better performance. A T-score of 50 indicates the population mean (average) with a standard deviation of 10.
Measured: 6 weeks
Verbal Learning From the Measurement and Treatment Research to Improve Cognition in Schizophrenia (MATRICS) Consensus Cognitive Battery (MCCB)
Hopkins Verbal Learning Test-Revised (HVLT-R): An orally
administered test in which a list of 12 words from three taxonomic categories is presented and the respondent is asked to recall as many as possible after each of three learning trials. T-scores range from 0-100, with higher T-scores corresponding to better performance. A T-score of 50 indicates the population mean (average) with a standard deviation of 10.
Measured: 6 months followup
Visual Learning From the Measurement and Treatment Research to Improve Cognition in Schizophrenia (MATRICS) Consensus Cognitive Battery (MCCB)
Brief Visuospatial Memory Test-Revised (BVMT-RTM): A test that involves reproducing six geometric figures from memory. T-scores range from 0-100, with higher T-scores corresponding to better performance. A T-score of 50 indicates the population mean (average) with a standard deviation of 10.
Measured: baseline
Visual Learning From the Measurement and Treatment Research to Improve Cognition in Schizophrenia (MATRICS) Consensus Cognitive Battery (MCCB)
Brief Visuospatial Memory Test-Revised (BVMT-RTM): A test that involves reproducing six geometric figures from memory. T-scores range from 0-100, with higher T-scores corresponding to better performance. A T-score of 50 indicates the population mean (average) with a standard deviation of 10.
Measured: 6 weeks
Visual Learning From the Measurement and Treatment Research to Improve Cognition in Schizophrenia (MATRICS) Consensus Cognitive Battery (MCCB)
Brief Visuospatial Memory Test-Revised (BVMT-RTM): A test that involves reproducing six geometric figures from memory. T-scores range from 0-100, with higher T-scores corresponding to better performance. A T-score of 50 indicates the population mean (average) with a standard deviation of 10.
Measured: 6 months followup
Problem Solving From the Measurement and Treatment Research to Improve Cognition in Schizophrenia (MATRICS) Consensus Cognitive Battery (MCCB)
Neuropsychological Assessment Battery® (NAB®): Mazes: Seven timed paper-and-pencil mazes of increasing difficulty that measure foresight and planning. T-scores range from 0-100, with higher T-scores corresponding to better performance. A T-score of 50 indicates the population mean (average) with a standard deviation of 10.
Measured: baseline
Problem Solving From the Measurement and Treatment Research to Improve Cognition in Schizophrenia (MATRICS) Consensus Cognitive Battery (MCCB)
Neuropsychological Assessment Battery® (NAB®): Mazes: Seven timed paper-and-pencil mazes of increasing difficulty that measure foresight and planning. T-scores range from 0-100, with higher T-scores corresponding to better performance. A T-score of 50 indicates the population mean (average) with a standard deviation of 10.
Measured: 6 weeks
Problem Solving From the Measurement and Treatment Research to Improve Cognition in Schizophrenia (MATRICS) Consensus Cognitive Battery (MCCB)
Neuropsychological Assessment Battery® (NAB®): Mazes: Seven timed paper-and-pencil mazes of increasing difficulty that measure foresight and planning. T-scores range from 0-100, with higher T-scores corresponding to better performance. A T-score of 50 indicates the population mean (average) with a standard deviation of 10.
Measured: 6 months followup
Social Cognition From the Measurement and Treatment Research to Improve Cognition in Schizophrenia (MATRICS) Consensus Cognitive Battery (MCCB)
Mayer-Salovey-Caruso Emotional Intelligence Test(MSCEIT™ ): Managing Emotions: Paper-and-pencil multiple-choice test that assesses how people manage their emotions. T-scores range from 0-100, with higher T-scores corresponding to better performance. A T-score of 50 indicates the population mean (average) with a standard deviation of 10.
Measured: baseline
Social Cognition From the Measurement and Treatment Research to Improve Cognition in Schizophrenia (MATRICS) Consensus Cognitive Battery (MCCB)
Mayer-Salovey-Caruso Emotional Intelligence Test(MSCEIT™ ): Managing Emotions: Paper-and-pencil multiple-choice test that assesses how people manage their emotions. T-scores range from 0-100, with higher T-scores corresponding to better performance. A T-score of 50 indicates the population mean (average) with a standard deviation of 10.
Measured: 6 weeks
Social Cognition From the Measurement and Treatment Research to Improve Cognition in Schizophrenia (MATRICS) Consensus Cognitive Battery (MCCB)
Mayer-Salovey-Caruso Emotional Intelligence Test(MSCEIT™ ): Managing Emotions: Paper-and-pencil multiple-choice test that assesses how people manage their emotions. T-scores range from 0-100, with higher T-scores corresponding to better performance. A T-score of 50 indicates the population mean (average) with a standard deviation of 10.
Measured: 6 months followup
Global Cognition From the Measurement and Treatment Research to Improve Cognition in Schizophrenia (MATRICS) Consensus Cognitive Battery (MCCB)
A composite score of the 7 scores listed above: Speed of Processing, Attention, Working Memory, Verbal Learning, Visual Learning, Problem Solving, and Social Cognition. The composite T-score is the average T-score across the 7 measures. T-scores range from 0-100, with higher T-scores corresponding to better performance. A T-score of 50 indicates the population mean (average) with a standard deviation of 10.
Measured: baseline
Global Cognition From the Measurement and Treatment Research to Improve Cognition in Schizophrenia (MATRICS) Consensus Cognitive Battery (MCCB)
A composite score of the 7 scores listed above: Speed of Processing, Attention, Working Memory, Verbal Learning, Visual Learning, Problem Solving, and Social Cognition. The composite T-score is the average T-score across the 7 measures. T-scores range from 0-100, with higher T-scores corresponding to better performance. A T-score of 50 indicates the population mean (average) with a standard deviation of 10.
Measured: 6 weeks
Global Cognition From the Measurement and Treatment Research to Improve Cognition in Schizophrenia (MATRICS) Consensus Cognitive Battery (MCCB)
A composite score of the 7 scores listed above: Speed of Processing, Attention, Working Memory, Verbal Learning, Visual Learning, Problem Solving, and Social Cognition. The composite T-score is the average T-score across the 7 measures. T-scores range from 0-100, with higher T-scores corresponding to better performance. A T-score of 50 indicates the population mean (average) with a standard deviation of 10.
Measured: 6 months followup
Emotion Recognition From the University of Pennsylvania Computerized Neurobehavioral Test Battery
Emotion Recognition: Participants are shown a series of 40 faces, one at a time, and asked to determine what emotion the face is showing for each trial. There are 5 answer choices: happy, sad, anger, fear and no emotion. Scores (i.e. correct responses) range from 0-40 with higher scores corresponding to better performance.
Measured: baseline
Emotional Prosody Identification From the University of Pennsylvania Computerized Neurobehavioral Test Battery Neurobehavioral Test Battery
Emotional Prosody Identification: Participants are presented a series of 80 audio clips played one at a time, and asked to determine what emotion the audio clip portrayed. There are 5 answer choices: Happy, Sad, Anger, Fearful and No Emotion. Scores (i.e. correct responses) range from 0-80 with higher scores corresponding to better performance.
Measured: Baseline
Emotional Prosody Identification From the University of Pennsylvania Computerized Neurobehavioral Test Battery
Emotional Prosody Identification: Participants are presented a series of 80 audio clips played one at a time, and asked to determine what emotion the audio clip portrayed. There are 5 answer choices: Happy, Sad, Anger, Fearful and No Emotion. Scores (i.e. correct responses) range from 0-80 with higher scores corresponding to better performance.
Measured: 6 weeks
Emotion Recognition From the University of Pennsylvania Computerized Neurobehavioral Test Battery
Emotion Recognition: Participants are shown a series of 40 faces, one at a time, and asked to determine what emotion the face is showing for each trial. There are 5 answer choices: happy, sad, anger, fear and no emotion. Scores (i.e. correct responses) range from 0-40 with higher scores corresponding to better performance.
Measured: 6 weeks
Emotion Recognition From the University of Pennsylvania Computerized Neurobehavioral Test Battery
Emotion Recognition: Participants are shown a series of 40 faces, one at a time, and asked to determine what emotion the face is showing for each trial. There are 5 answer choices: happy, sad, anger, fear and no emotion. Scores (i.e. correct responses) range from 0-40 with higher scores corresponding to better performance.
Measured: 6 months
Emotional Prosody Identification From the University of Pennsylvania Computerized Neurobehavioral Test Battery
Emotional Prosody Identification: Participants are presented a series of 80 audio clips played one at a time, and asked to determine what emotion the audio clip portrayed. There are 5 answer choices: Happy, Sad, Anger, Fearful and No Emotion. Scores (i.e. correct responses) range from 0-80 with higher scores corresponding to better performance.
Measured: 6 months
Faux Pas Test Theory of Mind
Faux Pas Test: Brief stories are read to the participant, and the participant is asked if someone in the story made a faux pas. This test assesses the ability to infer other peoples' mental states, thoughts and feelings. Scores (i.e. percent correct) range from 0-100% with higher scores corresponding to better performance.
Measured: Baseline
Faux Pas Test Theory of Mind
Faux Pas Test: Brief stories are read to the participant, and the participant is asked if someone in the story made a faux pas. This test assesses the ability to infer other peoples' mental states, thoughts and feelings. Scores (i.e. percent correct) range from 0-100% with higher scores corresponding to better performance.
Measured: 6 weeks
Faux Pas Test Theory of Mind
Faux Pas Test: Brief stories are read to the participant, and the participant is asked if someone in the story made a faux pas. This test assesses the ability to infer other peoples' mental states, thoughts and feelings. Scores (i.e. percent correct) range from 0-100% with higher scores corresponding to better performance.
Measured: 6 months followup
Quality of Life Scale-Abbreviated (Functioning)
Functioning: This measure assesses quality of life using subjective questions regarding life satisfaction and objective indicators of social and occupational functioning. Participants are asked questions about social and occupational functioning and intrapsychic foundations (e.g. motivation, sense of purpose, curiosity). The assessor provides ratings on a scale of 0-6 (e.g. absent to adequate). A mean item score is computed as the average rating across all items, with higher mean item scores corresponding to better functioning.
Measured: baseline
Quality of Life Scale-Abbreviated (Functioning)
Functioning: This measure assesses quality of life using subjective questions regarding life satisfaction and objective indicators of social and occupational functioning. Participants are asked questions about social and occupational functioning and intrapsychic foundations (e.g. motivation, sense of purpose, curiosity). The assessor provides ratings on a scale of 0-6 (e.g. absent to adequate). A mean item score is computed as the average rating across all items, with higher mean item scores corresponding to better functioning.
Measured: 6 weeks
Quality of Life Scale-Abbreviated (Functioning)
Functioning: This measure assesses quality of life using subjective questions regarding life satisfaction and objective indicators of social and occupational functioning. Participants are asked questions about social and occupational functioning and intrapsychic foundations (e.g. motivation, sense of purpose, curiosity). The assessor provides ratings on a scale of 0-6 (e.g. absent to adequate). A mean item score is computed as the average rating across all items, with higher mean item scores corresponding to better functioning.
Measured: 6 months followup
Auditory Processing Speed From the Posit Science Sound Sweeps Assessment
Auditory Processing Speed: In Sound Sweeps, participants listen to frequency sweeps-sounds that begin low and rise upward or begin high and fall downward-and identify whether they go up ("weep") or down ("woop"). The sweeps become progressively faster and are separated by shorter interstimulus intervals. The outcome is the threshold reached by the participant which is the fastest interstimulus interval (in milliseconds) at which the participant correctly performed. Scores ranged from 24-1000 milliseconds with lower scores indicating better performance.
Measured: Baseline
Auditory Processing Speed From the Posit Science Sound Sweeps Assessment
Auditory Processing Speed: In Sound Sweeps, participants listen to frequency sweeps-sounds that begin low and rise upward or begin high and fall downward-and identify whether they go up ("weep") or down ("woop"). The sweeps become progressively faster and are separated by shorter interstimulus intervals. The outcome is the threshold reached by the participant which is the fastest interstimulus interval (in milliseconds) at which the participant correctly performed. Scores ranged from 24-1000 milliseconds with lower scores indicating better performance.
Measured: 6 weeks
Auditory Processing Speed From the Posit Science Sound Sweeps Assessment
Auditory Processing Speed: In Sound Sweeps, participants listen to frequency sweeps-sounds that begin low and rise upward or begin high and fall downward-and identify whether they go up ("weep") or down ("woop"). The sweeps become progressively faster and are separated by shorter interstimulus intervals. The outcome is the threshold reached by the participant which is the fastest interstimulus interval (in milliseconds) at which the participant correctly performed. Scores ranged from 24-1000 milliseconds with lower scores indicating better performance.
Measured: 6 months followup
Temporal Experience of Pleasures (TEPS):Reward Sensitivity--Anticipatory Pleasure
Reward Sensitivity--Anticipatory Pleasure: This measure assesses pleasure experienced in anticipation of something and consists of 10 items. An example item is: "When something exciting is coming up in my life, I really look forward to it." Participants rate how true the statement is for them on a scale of 1 (very false for me) to 6 (very true for me). A mean item score is computed as the average rating across all items, with higher mean item scores corresponding to greater anticipatory pleasure.
Measured: Baseline
Temporal Experience of Pleasures (TEPS):Reward Sensitivity--Anticipatory Pleasure
Reward Sensitivity--Anticipatory Pleasure: This measure assesses pleasure experienced in anticipation of something and consists of 10 items. An example item is: "When something exciting is coming up in my life, I really look forward to it." Participants rate how true the statement is for them on a scale of 1 (very false for me) to 6 (very true for me). A mean item score is computed as the average rating across all items, with higher mean item scores corresponding to greater anticipatory pleasure.
Measured: 6 weeks
Temporal Experience of Pleasures (TEPS):Reward Sensitivity--Anticipatory Pleasure
Reward Sensitivity--Anticipatory Pleasure: This measure assesses pleasure experienced in anticipation of something and consists of 10 items. An example item is: "When something exciting is coming up in my life, I really look forward to it." Participants rate how true the statement is for them on a scale of 1 (very false for me) to 6 (very true for me). A mean item score is computed as the average rating across all items, with higher mean item scores corresponding to greater anticipatory pleasure.
Measured: 6 months followup
Temporal Experience of Pleasures (TEPS): Reward Sensitivity--Consummatory Pleasure
Reward Sensitivity--Consummatory Pleasure: This measure assesses pleasure experienced in the moment and consists of 8 items. An example item is: "The smell of freshly cut grass is enjoyable to me." Participants rate how true the statement is for them on a scale of 1 (very false for me) to 6 (very true for me). A mean item score is computed as the average rating across all items, with higher mean item scores corresponding to greater consummatory pleasure.
Measured: Baseline
Temporal Experience of Pleasures (TEPS): Reward Sensitivity--Consummatory Pleasure
Reward Sensitivity--Consummatory Pleasure: This measure assesses pleasure experienced in the moment and consists of 8 items. An example item is: "The smell of freshly cut grass is enjoyable to me." Participants rate how true the statement is for them on a scale of 1 (very false for me) to 6 (very true for me). A mean item score is computed as the average rating across all items, with higher mean item scores corresponding to greater consummatory pleasure.
Measured: 6 weeks
Temporal Experience of Pleasures (TEPS): Reward Sensitivity--Consummatory Pleasure
Reward Sensitivity--Consummatory Pleasure: This measure assesses pleasure experienced in the moment and consists of 8 items. An example item is: "The smell of freshly cut grass is enjoyable to me." Participants rate how true the statement is for them on a scale of 1 (very false for me) to 6 (very true for me). A mean item score is computed as the average rating across all items, with higher mean item scores corresponding to greater consummatory pleasure.
Measured: 6 months followup
Verbal Memory: Delayed Recall From the Hopkins Verbal Learning Test-Revised Version (HVLT-R)
Verbal Memory: Delayed Recall: An orally administered test in which a list of 12 words from three taxonomic categories is presented and the respondent is asked to recall as many as possible after a 25 minute delay. T-scores range from 0-100, with higher T-scores corresponding to better performance. A T-score of 50 indicates the population mean (average) with a standard deviation of 10.
Measured: Baseline
Verbal Memory: Delayed Recall From the Hopkins Verbal Learning Test-Revised Version (HVLT-R)
Verbal Memory: Delayed Recall: An orally administered test in which a list of 12 words from three taxonomic categories is presented and the respondent is asked to recall as many as possible after a 25 minute delay. T-scores range from 0-100, with higher T-scores corresponding to better performance. A T-score of 50 indicates the population mean (average) with a standard deviation of 10.
Measured: 6 weeks
Verbal Memory: Delayed Recall From the Hopkins Verbal Learning Test-Revised Version (HVLT-R)
Verbal Memory: Delayed Recall: An orally administered test in which a list of 12 words from three taxonomic categories is presented and the respondent is asked to recall as many as possible after a 25 minute delay. T-scores range from 0-100, with higher T-scores corresponding to better performance. A T-score of 50 indicates the population mean (average) with a standard deviation of 10.
Measured: 6months followup
Visual Memory: Delayed Recall From the Brief Visuospatial Memory Test-Revised Version (BVMT-R)
Visual Memory: Delayed Recall: A test that involves reproducing six geometric
figures from memory after a 25 minute delay. T-scores range from 0-100, with higher T-scores corresponding to better performance. A T-score of 50 indicates the population mean (average) with a standard deviation of 10.
Measured: baseline
Visual Memory: Delayed Recall From the Brief Visuospatial Memory Test-Revised Version (BVMT-R)
Visual Memory: Delayed Recall: A test that involves reproducing six geometric
figures from memory after a 25 minute delay. T-scores range from 0-100, with higher T-scores corresponding to better performance. A T-score of 50 indicates the population mean (average) with a standard deviation of 10.
Measured: 6 weeks
Visual Memory: Delayed Recall From the Brief Visuospatial Memory Test-Revised Version (BVMT-R)
Visual Memory: Delayed Recall: A test that involves reproducing six geometric
figures from memory after a 25 minute delay. T-scores range from 0-100, with higher T-scores corresponding to better performance. A T-score of 50 indicates the population mean (average) with a standard deviation of 10.
Measured: 6 months followup
Secondary outcomes (9)
UCSF Performance-Based Skills Assessment (UPSA): Functional Capacity
Functional Capacity: This measure assesses how well everyday tasks are performed in two areas of functioning: communication (e.g. making an emergency call, calling a doctor to reschedule an appointment) and finances (e.g. counting change, reading a utility bill). Scaled scores range from 0-100 with higher scores indicating better performance.
Measured: Baseline
UCSF Performance-Based Skills Assessment (UPSA): Functional Capacity
Functional Capacity: This measure assesses how well everyday tasks are performed in two areas of functioning: communication (e.g. making an emergency call, calling a doctor to reschedule an appointment) and finances (e.g. counting change, reading a utility bill). Scaled scores range from 0-100 with higher scores indicating better performance.
Measured: 6 weeks
UCSF Performance-Based Skills Assessment (UPSA): Functional Capacity
Functional Capacity: This measure assesses how well everyday tasks are performed in two areas of functioning: communication (e.g. making an emergency call, calling a doctor to reschedule an appointment) and finances (e.g. counting change, reading a utility bill). Scaled scores range from 0-100 with higher scores indicating better performance.
Measured: 6 months followup
Social Functioning Scale
Social Functioning: This measure assesses social skills and functioning in 7 domains: Withdrawal, Interaction, Pro-Social, Recreation, Independence- Performance, Independence-Competence, and Occupational. A mean domain score was calculated as the average across all domains. Scaled scores range from 55-145 with higher scores indicating better functioning.
Measured: Baseline
Social Functioning Scale
Social Functioning: This measure assesses social skills and functioning in 7 domains: Withdrawal, Interaction, Pro-Social, Recreation, Independence- Performance, Independence-Competence, and Occupational. A mean domain score was calculated as the average across all domains. Scaled scores range from 55-145 with higher scores indicating better functioning.
Measured: 6 weeks
Social Functioning Scale
Social Functioning: This measure assesses social skills and functioning in 7 domains: Withdrawal, Interaction, Pro-Social, Recreation, Independence- Performance, Independence-Competence, and Occupational. A mean domain score was calculated as the average across all domains. Scaled scores range from 55-145 with higher scores indicating better functioning.
Measured: 6 months followup
Internalized Stigma of Mental Illness (ISMI)
This measure assesses internalized stigma which occurs when a person adopts stigmatizing assumptions and stereotypes about mental illness. Participants rate 10 statements on a scale of 1 (strongly disagree) to 4 (strongly agree). A mean item score is computed as the average rating across all items, with higher mean item scores corresponding to greater internalized stigma.
Measured: Baseline
Internalized Stigma of Mental Illness (ISMI)
This measure assesses internalized stigma which occurs when a person adopts stigmatizing assumptions and stereotypes about mental illness. Participants rate 10 statements on a scale of 1 (strongly disagree) to 4 (strongly agree). A mean item score is computed as the average rating across all items, with higher mean item scores corresponding to greater internalized stigma.
Measured: 6 weeks
Internalized Stigma of Mental Illness (ISMI)
This measure assesses internalized stigma which occurs when a person adopts stigmatizing assumptions and stereotypes about mental illness. Participants rate 10 statements on a scale of 1 (strongly disagree) to 4 (strongly agree). A mean item score is computed as the average rating across all items, with higher mean item scores corresponding to greater internalized stigma.
Measured: 6 months followup
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Mar 2017
- Study start19 May 2017
- Primary completion26 Mar 2022
- Study completion26 Mar 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for SchizophreniaStudies of the same condition, open and under way.
- More trials run by University of MinnesotaThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 45 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Minnesota
- Sponsor type
- University, hospital or other
- Collaborators
- University of California, San Francisco
- Responsible party
- Sponsor
- Investigators
- Sophia Vinogradov, MD, Principal investigator, University of Minnesota Department of Psychiatry
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03079024
- Sponsor's protocol ID
- PSYCH-2017-25503
- Acronym
- Mini-COTES
- Status last verified
- Jan 2025
- First submitted
- 9 Feb 2017
- Last updated
- 23 Jan 2025
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- Yes: All assessment and training data and supporting information may be made available to collaborators upon request. Collaborators will need to enter into proper agreements with the PI and Institution before access is granted.
Study at a glance
From the registry record, last updated by the sponsor on 23 Jan 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Minnesota Community-Based Cognitive Training in Early Psychosis
- ClinicalTrials.gov ID
- NCT03079024
- Acronym / sponsor ID
- Mini-COTES / PSYCH-2017-25503
- Conditions
- Schizophrenia, Psychosis, Schizoaffective Disorder, Schizophreniform Disorders, Psychosis NOS, Depression Psychotic Feature
- Keywords
- Cognitive Training, First Episode Psychosis, Recent Onset Psychosis
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 45 participants (actual)
- Lead sponsor
- University of MinnesotaUniversity, hospital or other
- Collaborators
- University of California, San Francisco
- Study start
- 19 May 2017 (actual)
- Primary completion
- 26 Mar 2022 (actual)
- Study completion
- 26 Mar 2022 (actual)
- First posted
- 14 Mar 2017 (actual)
- Results
- Posted 23 Jan 2025
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of this study is to determine whether cognitive training exercises can improve cognitive functioning in young patients with recent-onset psychosis who are being treated in community mental health settings using the NAVIGATE model. The investigators will examine the effects of web-based cognitive training exercises delivered on iPads. Participants will be randomized to one of three conditions, and will be assessed at Baseline, Post-Intervention, and 6 Month Follow Up on measures of clinical, neurocognitive, and functional status.
Detailed description
The purpose of this study is to perform a double-blind randomized controlled trial (RCT) in young patients with First Episode Psychosis (FEP) to target improvement in cognitive functioning within real-world treatment settings. This study will be performed in the University of Minnesota Department of Psychiatry; patients will be recruited from local community based mental health care settings that implement a NAVIGATE model for FEP.
All participants will undergo baseline assessment in measures of clinical, neurocognitive, and functional status prior to randomization. Participants will be equally randomized to one of three groups: Targeted Cognitive Training (TCT); General Cognitive Exercises (GCE); or Treatment as Usual (TAU). Participants assigned to a cognitive training group will be loaned an iPad to complete study training at home. They will complete 60 minutes of training 5 times a week over the course of 6 weeks for a total of 30 hours of training. Participants will be allowed up to 12 weeks to complete the full 30 hours. Participants will return after 30 hours of training or 12 weeks, whichever comes first, for Post-Intervention Assessments. Then participants will enter a no-contact follow up period, until it is time for their 6 Month Follow Up assessment.
Specific Aims:
- Perform a double-blind RCT of web-based, portable computerized cognitive training in young individuals with recent onset psychosis receiving treatment within the University of Minnesota, Department of Psychiatry's First Episode Psychosis Program or other state clinics utilizing the NAVIGATE treatment model.
- Compare the clinical and cognitive effects of neural system-informed TCT that focuses explicitly and specifically on distributed neural system efficiency in auditory/verbal and social cognitive domains, vs. more non-specific GCE designed to enhance executive functioning and problem-solving, vs. TAU. Determine the durability of these effects and their relationship to functional outcome over a 6 month period.
- As a secondary aim, investigate the feasibility, tolerability, and acceptability of the intervention by service providers, clients, and caregivers in these real-world treatment centers.
Hypotheses to be tested:
- TCT subjects will show significantly greater gains in general cognition, verbal learning/memory, and social cognition compared to GCE and TAU subjects. These gains in the TCT group will be sustained at 6-month follow-up.
- GCE subjects will show improvement in problem-solving and global cognition compared to TAU subjects. At 6 month follow-up, GCE subjects will show lower gains in global cognition and verbal learning/memory than TCT subjects.
- Gains in general cognition and processing speed, and in social cognition in TCT subjects will correlate with improvements on 6-month measures of occupational and social functioning, respectively, as well as internalized stigma. These associations will be significantly greater in TCT subjects vs. GCE or TAU subjects.
- Symptom ratings will show improvement in all subject groups at 6 months, with no significant between-group differences.
- At least 70% of randomized clients will complete >20 hours of training in the TCT and GCE arms.
- Participants and clinicians will rate the TCT and GCE interventions as equally feasible, tolerable, and acceptable.
Participants from this study will also be recruited to participate in an adjunct protocol conducted by Dr. Sophia Vinogradov, titled "Is cognitive training neuroprotective in early psychosis?" NCT03049800.
Data from this project will be analysed with a sister protocol conducted by Dr. Rachel Loewy at the University of California San Francisco, titled "Community-Based Cognitive Training in Early Schizophrenia (COTES)," NCT01973270.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Targeted Cognitive Training (TCT) | Experimental | Device: Targeted Cognitive Training, Other: Coordinated Specialty Care for First Episode PsychosisNeuroadaptive Cognitive Training |
| General Cognitive Exercises (GCE) | Experimental | Device: General Cognitive Exercises, Other: Coordinated Specialty Care for First Episode PsychosisNeuroadaptive cognitive training |
| Treatment as Usual (TAU) | Active comparator | Other: Coordinated Specialty Care for First Episode PsychosisTreatment as Usual |
Who may qualify
- Ages
- 16 to 35 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (7 listed)
- Clinical diagnosis of schizophrenia, schizoaffective disorder, schizophreniform disorder, major depressive disorder with psychotic features, bipolar disorder with psychotic features, psychosis disorder not otherwise specified, or unspecified schizophrenia spectrum disorder, and started receiving treatment services at a First Episode Psychosis Program within the last two years
- Good general physical health
- Aged between 16 and 35 years (inclusive)
- Fluent in spoken and written English
- No neurological disorder (diagnosis of Autism Spectrum Disorder is allowed)
Key exclusion criteria (5 listed)
- Unable to provide informed consent
- Participated in significant cognitive training programs within the last three years
- Clinically significant substance abuse that is impeding the subject's ability to participate fully during recruitment, assessment, or training (is unable to remain sober for assessments and training).
- Prescribed >0.5mg daily benztropine (Congentin), >25mg daily diphenhydramine, or high doses of clozapine (>500 mg po qd) or olanzapine (to be determined on a case by case basis).
- Active suicidal ideation at screening or baseline, or previous intent to act on suicidal ideation with a specific plan, preparatory acts, or an actual suicide attempt within the last 6 months, as indicated by the C-SSRS
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Targeted Cognitive Training1. Auditory Training Module (20 hours): exercises designed to improve speed and accuracy of auditory processing while engaging working memory and cognitive control. Exercises adjust difficulty level to maintain an ~80% correct performance. Exercises contain stimuli spanning the acoustic organization of speech. In the initial stages, stimuli exaggerate the rapid temporal transitions by increasing amplitude and stretching in time. The exaggeration is gradually removed so that by the end, all stimuli have characteristics representative of real-world speech. 2. Social Cognition Module (10 hours): exercises designed to improve core deficits of social cognition in psychosis. Exercises apply principles of implicit learning to restore capacity to process and utilize socially-relevant information, and includes training to improve perception of affect (visual/vocal) and social cues (faces, gazes, social situations), theory of mind, self-referential style, emotion labeling and working memory. | Device | Targeted Cognitive Training (TCT) |
| General Cognitive ExercisesThe GCE will focus on executive dysfunction, as this domain is a significant, functionally important area of deficit in schizophrenia and has been the target of many previous studies. We will train this domain using a suite of engaging, adaptive web-based exercises that target executive function, intelligence, and spatial navigation developed by Posit Science. The exercises will be provide engaging, adaptive training as described in the Targeted Cognitive Training. | Device | General Cognitive Exercises (GCE) |
| Coordinated Specialty Care for First Episode PsychosisIndividuals in this study are receiving care from a coordinated specialty care clinic (CSC) for first episode psychosis. These clinics are following the NAVIGATE treatment model for early psychosis. | Other | General Cognitive Exercises (GCE), Targeted Cognitive Training (TCT), Treatment as Usual (TAU) |
Primary outcome
Speed of Processing From the Measurement and Treatment Research to Improve Cognition in Schizophrenia (MATRICS) Consensus Cognitive Battery (MCCB)
Time frame: baseline
A composite T-score of: 1. Symbol Coding from the Brief Assessment of Cognition in Schizophrenia (BACS): Symbol Coding. Timed paper-and-pencil test in which respondent uses a key to write digits that correspond to nonsense symbols. 2. Category Fluency: Animal Naming: Oral test in which respondent names as many animals as she/he can in 1 minute. 3. Trail Making Test: Part A: Timed paper-and-pencil test in which respondent draws a line to connect consecutively numbered circles placed irregularly on a sheet of paper. The composite T-score is the average T-score across the 3 measures. T-scores range from 0-100, with higher T-scores corresponding to better performance. A T- score of 50 indicates the population mean (average) with a standard deviation of 10.
Speed of Processing From the Measurement and Treatment Research to Improve Cognition in Schizophrenia (MATRICS) Consensus Cognitive Battery (MCCB)
Time frame: 6 weeks
A composite T-score of: 1. Symbol Coding from the Brief Assessment of Cognition in Schizophrenia (BACS): Symbol Coding. Timed paper-and-pencil test in which respondent uses a key to write digits that correspond to nonsense symbols. 2. Category Fluency: Animal Naming: Oral test in which respondent names as many animals as she/he can in 1 minute. 3. Trail Making Test: Part A: Timed paper-and-pencil test in which respondent draws a line to connect consecutively numbered circles placed irregularly on a sheet of paper. The composite T-score is the average T-score across the 3 measures. T-scores range from 0-100, with higher T-scores corresponding to better performance. A T- score of 50 indicates the population mean (average) with a standard deviation of 10.
Speed of Processing From the Measurement and Treatment Research to Improve Cognition in Schizophrenia (MATRICS) Consensus Cognitive Battery (MCCB)
Time frame: 6 months followup
A composite T-score of: 1. Symbol Coding from the Brief Assessment of Cognition in Schizophrenia (BACS): Symbol Coding. Timed paper-and-pencil test in which respondent uses a key to write digits that correspond to nonsense symbols. 2. Category Fluency: Animal Naming: Oral test in which respondent names as many animals as she/he can in 1 minute. 3. Trail Making Test: Part A: Timed paper-and-pencil test in which respondent draws a line to connect consecutively numbered circles placed irregularly on a sheet of paper. The composite T-score is the average T-score across the 3 measures. T-scores range from 0-100, with higher T-scores corresponding to better performance. A T- score of 50 indicates the population mean (average) with a standard deviation of 10.
Attention From the Measurement and Treatment Research to Improve Cognition in Schizophrenia (MATRICS) Consensus Cognitive Battery (MCCB)
Time frame: baseline
Continuous Performance Test-Identical Pairs (CPT-IP): A computer- administered measure of sustained attention in which respondent presses a response button to consecutive matching numbers. T-scores range from 0-100, with higher T-scores corresponding to better performance. A T-score of 50 indicates the population mean (average) with a standard deviation of 10.
Attention From the Measurement and Treatment Research to Improve Cognition in Schizophrenia (MATRICS) Consensus Cognitive Battery (MCCB)
Time frame: 6 weeks
Continuous Performance Test-Identical Pairs (CPT-IP): A computer- administered measure of sustained attention in which respondent presses a response button to consecutive matching numbers. T-scores range from 0-100, with higher T-scores corresponding to better performance. A T-score of 50 indicates the population mean (average) with a standard deviation of 10.
Attention From the Measurement and Treatment Research to Improve Cognition in Schizophrenia (MATRICS) Consensus Cognitive Battery (MCCB)
Time frame: 6 months followup
Continuous Performance Test-Identical Pairs (CPT-IP): A computer- administered measure of sustained attention in which respondent presses a response button to consecutive matching numbers. T-scores range from 0-100, with higher T-scores corresponding to better performance. A T-score of 50 indicates the population mean (average) with a standard deviation of 10.
Working Memory From the Measurement and Treatment Research to Improve Cognition in Schizophrenia (MATRICS) Consensus Cognitive Battery (MCCB)
Time frame: Basline
Verbal and Visual Working Memory: A composite score of the Letter- Number Span test and the Spatial Span test from the Wechsler Memory Scale®-3rd Ed. (WMS®-III). Letter-Number Span: An orally administered test in which respondent mentally reorders strings of number and letters and repeats them to administrator. Spatial Span: Using a board on which 10 cubes are irregularly spaced, respondent taps cubes in same (or reverse) sequence as test administrator. The composite T-score is the average T-score across the 2 measures. T-scores range from 0-100, with higher T-scores corresponding to better performance. A T-score of 50 indicates the population mean (average) with a standard deviation of 10.
Working Memory From the Measurement and Treatment Research to Improve Cognition in Schizophrenia (MATRICS) Consensus Cognitive Battery (MCCB)
Time frame: 6 weeks
Verbal and Visual Working Memory: A composite score of the Letter- Number Span test and the Spatial Span test from the Wechsler Memory Scale®-3rd Ed. (WMS®-III). Letter-Number Span: An orally administered test in which respondent mentally reorders strings of number and letters and repeats them to administrator. Spatial Span: Using a board on which 10 cubes are irregularly spaced, respondent taps cubes in same (or reverse) sequence as test administrator. The composite T-score is the average T-score across the 2 measures. T-scores range from 0-100, with higher T-scores corresponding to better performance. A T-score of 50 indicates the population mean (average) with a standard deviation of 10.
Working Memory From the Measurement and Treatment Research to Improve Cognition in Schizophrenia (MATRICS) Consensus Cognitive Battery (MCCB)
Time frame: 6 months followup
Verbal and Visual Working Memory: A composite score of the Letter- Number Span test and the Spatial Span test from the Wechsler Memory Scale®-3rd Ed. (WMS®-III). Letter-Number Span: An orally administered test in which respondent mentally reorders strings of number and letters and repeats them to administrator. Spatial Span: Using a board on which 10 cubes are irregularly spaced, respondent taps cubes in same (or reverse) sequence as test administrator. The composite T-score is the average T-score across the 2 measures. T-scores range from 0-100, with higher T-scores corresponding to better performance. A T-score of 50 indicates the population mean (average) with a standard deviation of 10.
Verbal Learning From the Measurement and Treatment Research to Improve Cognition in Schizophrenia (MATRICS) Consensus Cognitive Battery (MCCB)
Time frame: Baseline
Hopkins Verbal Learning Test-Revised (HVLT-R): An orally administered test in which a list of 12 words from three taxonomic categories is presented and the respondent is asked to recall as many as possible after each of three learning trials. T-scores range from 0-100, with higher T-scores corresponding to better performance. A T-score of 50 indicates the population mean (average) with a standard deviation of 10.
Verbal Learning From the Measurement and Treatment Research to Improve Cognition in Schizophrenia (MATRICS) Consensus Cognitive Battery (MCCB)
Time frame: 6 weeks
Hopkins Verbal Learning Test-Revised (HVLT-R): An orally administered test in which a list of 12 words from three taxonomic categories is presented and the respondent is asked to recall as many as possible after each of three learning trials. T-scores range from 0-100, with higher T-scores corresponding to better performance. A T-score of 50 indicates the population mean (average) with a standard deviation of 10.
Verbal Learning From the Measurement and Treatment Research to Improve Cognition in Schizophrenia (MATRICS) Consensus Cognitive Battery (MCCB)
Time frame: 6 months followup
Hopkins Verbal Learning Test-Revised (HVLT-R): An orally administered test in which a list of 12 words from three taxonomic categories is presented and the respondent is asked to recall as many as possible after each of three learning trials. T-scores range from 0-100, with higher T-scores corresponding to better performance. A T-score of 50 indicates the population mean (average) with a standard deviation of 10.
Visual Learning From the Measurement and Treatment Research to Improve Cognition in Schizophrenia (MATRICS) Consensus Cognitive Battery (MCCB)
Time frame: baseline
Brief Visuospatial Memory Test-Revised (BVMT-RTM): A test that involves reproducing six geometric figures from memory. T-scores range from 0-100, with higher T-scores corresponding to better performance. A T-score of 50 indicates the population mean (average) with a standard deviation of 10.
Visual Learning From the Measurement and Treatment Research to Improve Cognition in Schizophrenia (MATRICS) Consensus Cognitive Battery (MCCB)
Time frame: 6 weeks
Brief Visuospatial Memory Test-Revised (BVMT-RTM): A test that involves reproducing six geometric figures from memory. T-scores range from 0-100, with higher T-scores corresponding to better performance. A T-score of 50 indicates the population mean (average) with a standard deviation of 10.
Visual Learning From the Measurement and Treatment Research to Improve Cognition in Schizophrenia (MATRICS) Consensus Cognitive Battery (MCCB)
Time frame: 6 months followup
Brief Visuospatial Memory Test-Revised (BVMT-RTM): A test that involves reproducing six geometric figures from memory. T-scores range from 0-100, with higher T-scores corresponding to better performance. A T-score of 50 indicates the population mean (average) with a standard deviation of 10.
Problem Solving From the Measurement and Treatment Research to Improve Cognition in Schizophrenia (MATRICS) Consensus Cognitive Battery (MCCB)
Time frame: baseline
Neuropsychological Assessment Battery® (NAB®): Mazes: Seven timed paper-and-pencil mazes of increasing difficulty that measure foresight and planning. T-scores range from 0-100, with higher T-scores corresponding to better performance. A T-score of 50 indicates the population mean (average) with a standard deviation of 10.
Problem Solving From the Measurement and Treatment Research to Improve Cognition in Schizophrenia (MATRICS) Consensus Cognitive Battery (MCCB)
Time frame: 6 weeks
Neuropsychological Assessment Battery® (NAB®): Mazes: Seven timed paper-and-pencil mazes of increasing difficulty that measure foresight and planning. T-scores range from 0-100, with higher T-scores corresponding to better performance. A T-score of 50 indicates the population mean (average) with a standard deviation of 10.
Problem Solving From the Measurement and Treatment Research to Improve Cognition in Schizophrenia (MATRICS) Consensus Cognitive Battery (MCCB)
Time frame: 6 months followup
Neuropsychological Assessment Battery® (NAB®): Mazes: Seven timed paper-and-pencil mazes of increasing difficulty that measure foresight and planning. T-scores range from 0-100, with higher T-scores corresponding to better performance. A T-score of 50 indicates the population mean (average) with a standard deviation of 10.
Social Cognition From the Measurement and Treatment Research to Improve Cognition in Schizophrenia (MATRICS) Consensus Cognitive Battery (MCCB)
Time frame: baseline
Mayer-Salovey-Caruso Emotional Intelligence Test(MSCEIT™ ): Managing Emotions: Paper-and-pencil multiple-choice test that assesses how people manage their emotions. T-scores range from 0-100, with higher T-scores corresponding to better performance. A T-score of 50 indicates the population mean (average) with a standard deviation of 10.
Social Cognition From the Measurement and Treatment Research to Improve Cognition in Schizophrenia (MATRICS) Consensus Cognitive Battery (MCCB)
Time frame: 6 weeks
Mayer-Salovey-Caruso Emotional Intelligence Test(MSCEIT™ ): Managing Emotions: Paper-and-pencil multiple-choice test that assesses how people manage their emotions. T-scores range from 0-100, with higher T-scores corresponding to better performance. A T-score of 50 indicates the population mean (average) with a standard deviation of 10.
Social Cognition From the Measurement and Treatment Research to Improve Cognition in Schizophrenia (MATRICS) Consensus Cognitive Battery (MCCB)
Time frame: 6 months followup
Mayer-Salovey-Caruso Emotional Intelligence Test(MSCEIT™ ): Managing Emotions: Paper-and-pencil multiple-choice test that assesses how people manage their emotions. T-scores range from 0-100, with higher T-scores corresponding to better performance. A T-score of 50 indicates the population mean (average) with a standard deviation of 10.
Global Cognition From the Measurement and Treatment Research to Improve Cognition in Schizophrenia (MATRICS) Consensus Cognitive Battery (MCCB)
Time frame: baseline
A composite score of the 7 scores listed above: Speed of Processing, Attention, Working Memory, Verbal Learning, Visual Learning, Problem Solving, and Social Cognition. The composite T-score is the average T-score across the 7 measures. T-scores range from 0-100, with higher T-scores corresponding to better performance. A T-score of 50 indicates the population mean (average) with a standard deviation of 10.
Global Cognition From the Measurement and Treatment Research to Improve Cognition in Schizophrenia (MATRICS) Consensus Cognitive Battery (MCCB)
Time frame: 6 weeks
A composite score of the 7 scores listed above: Speed of Processing, Attention, Working Memory, Verbal Learning, Visual Learning, Problem Solving, and Social Cognition. The composite T-score is the average T-score across the 7 measures. T-scores range from 0-100, with higher T-scores corresponding to better performance. A T-score of 50 indicates the population mean (average) with a standard deviation of 10.
Global Cognition From the Measurement and Treatment Research to Improve Cognition in Schizophrenia (MATRICS) Consensus Cognitive Battery (MCCB)
Time frame: 6 months followup
A composite score of the 7 scores listed above: Speed of Processing, Attention, Working Memory, Verbal Learning, Visual Learning, Problem Solving, and Social Cognition. The composite T-score is the average T-score across the 7 measures. T-scores range from 0-100, with higher T-scores corresponding to better performance. A T-score of 50 indicates the population mean (average) with a standard deviation of 10.
Emotion Recognition From the University of Pennsylvania Computerized Neurobehavioral Test Battery
Time frame: baseline
Emotion Recognition: Participants are shown a series of 40 faces, one at a time, and asked to determine what emotion the face is showing for each trial. There are 5 answer choices: happy, sad, anger, fear and no emotion. Scores (i.e. correct responses) range from 0-40 with higher scores corresponding to better performance.
Emotional Prosody Identification From the University of Pennsylvania Computerized Neurobehavioral Test Battery Neurobehavioral Test Battery
Time frame: Baseline
Emotional Prosody Identification: Participants are presented a series of 80 audio clips played one at a time, and asked to determine what emotion the audio clip portrayed. There are 5 answer choices: Happy, Sad, Anger, Fearful and No Emotion. Scores (i.e. correct responses) range from 0-80 with higher scores corresponding to better performance.
Emotional Prosody Identification From the University of Pennsylvania Computerized Neurobehavioral Test Battery
Time frame: 6 weeks
Emotional Prosody Identification: Participants are presented a series of 80 audio clips played one at a time, and asked to determine what emotion the audio clip portrayed. There are 5 answer choices: Happy, Sad, Anger, Fearful and No Emotion. Scores (i.e. correct responses) range from 0-80 with higher scores corresponding to better performance.
Emotion Recognition From the University of Pennsylvania Computerized Neurobehavioral Test Battery
Time frame: 6 weeks
Emotion Recognition: Participants are shown a series of 40 faces, one at a time, and asked to determine what emotion the face is showing for each trial. There are 5 answer choices: happy, sad, anger, fear and no emotion. Scores (i.e. correct responses) range from 0-40 with higher scores corresponding to better performance.
Emotion Recognition From the University of Pennsylvania Computerized Neurobehavioral Test Battery
Time frame: 6 months
Emotion Recognition: Participants are shown a series of 40 faces, one at a time, and asked to determine what emotion the face is showing for each trial. There are 5 answer choices: happy, sad, anger, fear and no emotion. Scores (i.e. correct responses) range from 0-40 with higher scores corresponding to better performance.
Emotional Prosody Identification From the University of Pennsylvania Computerized Neurobehavioral Test Battery
Time frame: 6 months
Emotional Prosody Identification: Participants are presented a series of 80 audio clips played one at a time, and asked to determine what emotion the audio clip portrayed. There are 5 answer choices: Happy, Sad, Anger, Fearful and No Emotion. Scores (i.e. correct responses) range from 0-80 with higher scores corresponding to better performance.
Faux Pas Test Theory of Mind
Time frame: Baseline
Faux Pas Test: Brief stories are read to the participant, and the participant is asked if someone in the story made a faux pas. This test assesses the ability to infer other peoples' mental states, thoughts and feelings. Scores (i.e. percent correct) range from 0-100% with higher scores corresponding to better performance.
Faux Pas Test Theory of Mind
Time frame: 6 weeks
Faux Pas Test: Brief stories are read to the participant, and the participant is asked if someone in the story made a faux pas. This test assesses the ability to infer other peoples' mental states, thoughts and feelings. Scores (i.e. percent correct) range from 0-100% with higher scores corresponding to better performance.
Faux Pas Test Theory of Mind
Time frame: 6 months followup
Faux Pas Test: Brief stories are read to the participant, and the participant is asked if someone in the story made a faux pas. This test assesses the ability to infer other peoples' mental states, thoughts and feelings. Scores (i.e. percent correct) range from 0-100% with higher scores corresponding to better performance.
Quality of Life Scale-Abbreviated (Functioning)
Time frame: baseline
Functioning: This measure assesses quality of life using subjective questions regarding life satisfaction and objective indicators of social and occupational functioning. Participants are asked questions about social and occupational functioning and intrapsychic foundations (e.g. motivation, sense of purpose, curiosity). The assessor provides ratings on a scale of 0-6 (e.g. absent to adequate). A mean item score is computed as the average rating across all items, with higher mean item scores corresponding to better functioning.
Quality of Life Scale-Abbreviated (Functioning)
Time frame: 6 weeks
Functioning: This measure assesses quality of life using subjective questions regarding life satisfaction and objective indicators of social and occupational functioning. Participants are asked questions about social and occupational functioning and intrapsychic foundations (e.g. motivation, sense of purpose, curiosity). The assessor provides ratings on a scale of 0-6 (e.g. absent to adequate). A mean item score is computed as the average rating across all items, with higher mean item scores corresponding to better functioning.
Quality of Life Scale-Abbreviated (Functioning)
Time frame: 6 months followup
Functioning: This measure assesses quality of life using subjective questions regarding life satisfaction and objective indicators of social and occupational functioning. Participants are asked questions about social and occupational functioning and intrapsychic foundations (e.g. motivation, sense of purpose, curiosity). The assessor provides ratings on a scale of 0-6 (e.g. absent to adequate). A mean item score is computed as the average rating across all items, with higher mean item scores corresponding to better functioning.
Auditory Processing Speed From the Posit Science Sound Sweeps Assessment
Time frame: Baseline
Auditory Processing Speed: In Sound Sweeps, participants listen to frequency sweeps-sounds that begin low and rise upward or begin high and fall downward-and identify whether they go up ("weep") or down ("woop"). The sweeps become progressively faster and are separated by shorter interstimulus intervals. The outcome is the threshold reached by the participant which is the fastest interstimulus interval (in milliseconds) at which the participant correctly performed. Scores ranged from 24-1000 milliseconds with lower scores indicating better performance.
Auditory Processing Speed From the Posit Science Sound Sweeps Assessment
Time frame: 6 weeks
Auditory Processing Speed: In Sound Sweeps, participants listen to frequency sweeps-sounds that begin low and rise upward or begin high and fall downward-and identify whether they go up ("weep") or down ("woop"). The sweeps become progressively faster and are separated by shorter interstimulus intervals. The outcome is the threshold reached by the participant which is the fastest interstimulus interval (in milliseconds) at which the participant correctly performed. Scores ranged from 24-1000 milliseconds with lower scores indicating better performance.
Auditory Processing Speed From the Posit Science Sound Sweeps Assessment
Time frame: 6 months followup
Auditory Processing Speed: In Sound Sweeps, participants listen to frequency sweeps-sounds that begin low and rise upward or begin high and fall downward-and identify whether they go up ("weep") or down ("woop"). The sweeps become progressively faster and are separated by shorter interstimulus intervals. The outcome is the threshold reached by the participant which is the fastest interstimulus interval (in milliseconds) at which the participant correctly performed. Scores ranged from 24-1000 milliseconds with lower scores indicating better performance.
Temporal Experience of Pleasures (TEPS):Reward Sensitivity--Anticipatory Pleasure
Time frame: Baseline
Reward Sensitivity--Anticipatory Pleasure: This measure assesses pleasure experienced in anticipation of something and consists of 10 items. An example item is: "When something exciting is coming up in my life, I really look forward to it." Participants rate how true the statement is for them on a scale of 1 (very false for me) to 6 (very true for me). A mean item score is computed as the average rating across all items, with higher mean item scores corresponding to greater anticipatory pleasure.
Temporal Experience of Pleasures (TEPS):Reward Sensitivity--Anticipatory Pleasure
Time frame: 6 weeks
Reward Sensitivity--Anticipatory Pleasure: This measure assesses pleasure experienced in anticipation of something and consists of 10 items. An example item is: "When something exciting is coming up in my life, I really look forward to it." Participants rate how true the statement is for them on a scale of 1 (very false for me) to 6 (very true for me). A mean item score is computed as the average rating across all items, with higher mean item scores corresponding to greater anticipatory pleasure.
Temporal Experience of Pleasures (TEPS):Reward Sensitivity--Anticipatory Pleasure
Time frame: 6 months followup
Reward Sensitivity--Anticipatory Pleasure: This measure assesses pleasure experienced in anticipation of something and consists of 10 items. An example item is: "When something exciting is coming up in my life, I really look forward to it." Participants rate how true the statement is for them on a scale of 1 (very false for me) to 6 (very true for me). A mean item score is computed as the average rating across all items, with higher mean item scores corresponding to greater anticipatory pleasure.
Temporal Experience of Pleasures (TEPS): Reward Sensitivity--Consummatory Pleasure
Time frame: Baseline
Reward Sensitivity--Consummatory Pleasure: This measure assesses pleasure experienced in the moment and consists of 8 items. An example item is: "The smell of freshly cut grass is enjoyable to me." Participants rate how true the statement is for them on a scale of 1 (very false for me) to 6 (very true for me). A mean item score is computed as the average rating across all items, with higher mean item scores corresponding to greater consummatory pleasure.
Temporal Experience of Pleasures (TEPS): Reward Sensitivity--Consummatory Pleasure
Time frame: 6 weeks
Reward Sensitivity--Consummatory Pleasure: This measure assesses pleasure experienced in the moment and consists of 8 items. An example item is: "The smell of freshly cut grass is enjoyable to me." Participants rate how true the statement is for them on a scale of 1 (very false for me) to 6 (very true for me). A mean item score is computed as the average rating across all items, with higher mean item scores corresponding to greater consummatory pleasure.
Temporal Experience of Pleasures (TEPS): Reward Sensitivity--Consummatory Pleasure
Time frame: 6 months followup
Reward Sensitivity--Consummatory Pleasure: This measure assesses pleasure experienced in the moment and consists of 8 items. An example item is: "The smell of freshly cut grass is enjoyable to me." Participants rate how true the statement is for them on a scale of 1 (very false for me) to 6 (very true for me). A mean item score is computed as the average rating across all items, with higher mean item scores corresponding to greater consummatory pleasure.
Verbal Memory: Delayed Recall From the Hopkins Verbal Learning Test-Revised Version (HVLT-R)
Time frame: Baseline
Verbal Memory: Delayed Recall: An orally administered test in which a list of 12 words from three taxonomic categories is presented and the respondent is asked to recall as many as possible after a 25 minute delay. T-scores range from 0-100, with higher T-scores corresponding to better performance. A T-score of 50 indicates the population mean (average) with a standard deviation of 10.
Verbal Memory: Delayed Recall From the Hopkins Verbal Learning Test-Revised Version (HVLT-R)
Time frame: 6 weeks
Verbal Memory: Delayed Recall: An orally administered test in which a list of 12 words from three taxonomic categories is presented and the respondent is asked to recall as many as possible after a 25 minute delay. T-scores range from 0-100, with higher T-scores corresponding to better performance. A T-score of 50 indicates the population mean (average) with a standard deviation of 10.
Verbal Memory: Delayed Recall From the Hopkins Verbal Learning Test-Revised Version (HVLT-R)
Time frame: 6months followup
Verbal Memory: Delayed Recall: An orally administered test in which a list of 12 words from three taxonomic categories is presented and the respondent is asked to recall as many as possible after a 25 minute delay. T-scores range from 0-100, with higher T-scores corresponding to better performance. A T-score of 50 indicates the population mean (average) with a standard deviation of 10.
Visual Memory: Delayed Recall From the Brief Visuospatial Memory Test-Revised Version (BVMT-R)
Time frame: baseline
Visual Memory: Delayed Recall: A test that involves reproducing six geometric figures from memory after a 25 minute delay. T-scores range from 0-100, with higher T-scores corresponding to better performance. A T-score of 50 indicates the population mean (average) with a standard deviation of 10.
Visual Memory: Delayed Recall From the Brief Visuospatial Memory Test-Revised Version (BVMT-R)
Time frame: 6 weeks
Visual Memory: Delayed Recall: A test that involves reproducing six geometric figures from memory after a 25 minute delay. T-scores range from 0-100, with higher T-scores corresponding to better performance. A T-score of 50 indicates the population mean (average) with a standard deviation of 10.
Visual Memory: Delayed Recall From the Brief Visuospatial Memory Test-Revised Version (BVMT-R)
Time frame: 6 months followup
Visual Memory: Delayed Recall: A test that involves reproducing six geometric figures from memory after a 25 minute delay. T-scores range from 0-100, with higher T-scores corresponding to better performance. A T-score of 50 indicates the population mean (average) with a standard deviation of 10.
9 secondary outcomes
UCSF Performance-Based Skills Assessment (UPSA): Functional Capacity
Time frame: Baseline
UCSF Performance-Based Skills Assessment (UPSA): Functional Capacity
Time frame: 6 weeks
UCSF Performance-Based Skills Assessment (UPSA): Functional Capacity
Time frame: 6 months followup
Social Functioning Scale
Time frame: Baseline
Social Functioning Scale
Time frame: 6 weeks
Social Functioning Scale
Time frame: 6 months followup
Internalized Stigma of Mental Illness (ISMI)
Time frame: Baseline
Internalized Stigma of Mental Illness (ISMI)
Time frame: 6 weeks
Internalized Stigma of Mental Illness (ISMI)
Time frame: 6 months followup
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Jan 2025.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: Yes. All assessment and training data and supporting information may be made available to collaborators upon request. Collaborators will need to enter into proper agreements with the PI and Institution before access is granted.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Sophia Vinogradov, MD principal investigator
University of Minnesota Department of Psychiatry
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Targeted Cognitive Training, General Cognitive Exercises and Coordinated Specialty Care for First Episode Psychosis in people with Schizophrenia and Psychosis, run by University of Minnesota at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 23 Jan 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 23 Jan 2025). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Speed of Processing From the Measurement and Treatment Research to Improve Cognition in Schizophrenia (MATRICS) Consensus Cognitive Battery (MCCB) (time frame: baseline). The study lists 51 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 Jan 2025.