Minnesota Community-Based Cognitive Training in Early Psychosis

NCT03079024 | Completed Results FDA Device

• 1 other identifier: PSYCH-2017-25503
• Study Type: interventional
• Target: 45
• Locations: 1 country
• Sites: 1

Brief 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. 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.

Conditions

Schizophrenia; Psychosis; Schizoaffective Disorder; Schizophreniform Disorders; Psychosis NOS; Depression Psychotic Feature; Bipolar Disorder With Psychotic Features; Unspecified Psychosis

Keywords

Cognitive Training; First Episode Psychosis; Recent Onset Psychosis

Outcome Measures

Primary Outcomes (51)

• Speed of Processing From the Measurement and Treatment Research to Improve Cognition in Schizophrenia (MATRICS) Consensus Cognitive Battery (MCCB)

  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\.

  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: 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\.

  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: 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\.

  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.

  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.

  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.

  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.

  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.

  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.

  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.

  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.

  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.

  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.

  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.

  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.

  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.

  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.

  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.

  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.

  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.

  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.

  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.

  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.

  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.

  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.

  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.

  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.

  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.

  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.

  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.

  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.

  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.

  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.

  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.

  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.

  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.

  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.

  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.

  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.

  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.

  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.

  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.

  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.

  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.

  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.

  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.

  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.

  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.

  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.

  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.

  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.

  6 months followup

Secondary Outcomes (9)

• UCSF Performance-Based Skills Assessment (UPSA): Functional Capacity

  Baseline

• UCSF Performance-Based Skills Assessment (UPSA): Functional Capacity

  6 weeks

• UCSF Performance-Based Skills Assessment (UPSA): Functional Capacity

  6 months followup

• Social Functioning Scale

  Baseline

• Social Functioning Scale

  6 weeks

Study Arms (3)

Targeted Cognitive Training (TCT)

EXPERIMENTAL

Neuroadaptive Cognitive Training

Device: Targeted Cognitive Training; Other: Coordinated Specialty Care for First Episode Psychosis

General Cognitive Exercises (GCE)

EXPERIMENTAL

Neuroadaptive cognitive training

Device: General Cognitive Exercises; Other: Coordinated Specialty Care for First Episode Psychosis

Treatment as Usual (TAU)

ACTIVE COMPARATOR

Treatment as Usual

Other: Coordinated Specialty Care for First Episode Psychosis

Interventions

Targeted Cognitive Training DEVICE

1. 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.

Targeted Cognitive Training (TCT)

General Cognitive Exercises DEVICE

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.

General Cognitive Exercises (GCE)

Coordinated Specialty Care for First Episode Psychosis OTHER

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.

General Cognitive Exercises (GCE); Targeted Cognitive Training (TCT); Treatment as Usual (TAU)

Eligibility Criteria

• Age: 16 Years - 35 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Minnesota: lead
• University of California, San Francisco: collaborator

Study Sites (1)

University of Minnesota, Dept of Psychiatry

Minneapolis, Minnesota, 55116, United States

Location

MeSH Terms

Conditions

Schizophrenia; Psychotic Disorders; Mental Disorders

Condition Hierarchy (Ancestors)

Schizophrenia Spectrum and Other Psychotic Disorders

Limitations and Caveats

1\. Missing data: This study was conducted from 2017-2022. During the COVID-19 shutdown, we continued the study and shifted to all remote procedures, however several measures could not be administered remotely. 2. The BACS Tower of London was not administered to reduce participant burden, and since Reasoning and Problem Solving was already captured by the MATRICS battery.

Results Point of Contact

• Title: Melissa Fisher
• Organization: University of Minnesota

mafisher@umn.edu

(612) 273-9812

Study Officials

• Sophia Vinogradov, MD

  University of Minnesota Department of Psychiatry

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 9, 2017
• First Posted: March 14, 2017
• Study Start: May 19, 2017
• Primary Completion: March 26, 2022
• Study Completion: March 26, 2022
• Last Updated: January 23, 2025
• Results First Posted: January 23, 2025

Record last verified: 2025-01

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF, ANALYTIC CODE
• Time Frame: Study data will be available for sharing one year after the completion of the project.
• Access Criteria: Interested collaborators may contact the PI directly to request access to the study data. Collaborators will need to enter into Data Use Agreements with the PI and Institution, and limitations may be made on how data is shared (e.g., within a data shelter).

Locations

US (1)