University of Minnesota, Dept of Psychiatry
Minneapolis, Minnesota, 55116, United States
NCT Number: NCT03079024
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.
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Notify Me16 year–35 year
All sexes
Interventional
Not applicable
Minneapolis, Minnesota, 55116, United States
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:
Hypotheses to be tested:
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.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
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.
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.
Time frame: baseline
A composite T-score of:
10.
Time frame: 6 weeks
A composite T-score of:
10.
Time frame: 6 months followup
A composite T-score of:
10.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
Time frame: Baseline
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.
Time frame: 6 weeks
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.
Time frame: 6 months followup
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.
Time frame: Baseline
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.
Time frame: 6 weeks
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.
Time frame: 6 months followup
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.
Time frame: Baseline
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.
Time frame: 6 weeks
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.
Time frame: 6 months followup
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.
University of Minnesota
Other
Acronym: Mini-COTES
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