Minnesota Community-Based Cognitive Training in Early Psychosis

Not Applicable

Completed

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

Interventions: Device: Targeted Cognitive Training
Device: General Cognitive Exercises
Other: Coordinated Specialty Care for First Episode Psychosis

Registration Number: NCT03079024

Lead Sponsor: University of Minnesota

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.

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:

1. 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.

2. 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.

3. 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:

1. 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.

2. 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.

3. 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.

4. Symptom ratings will show improvement in all subject groups at 6 months, with no significant between-group differences.

5. At least 70% of randomized clients will complete \>20 hours of training in the TCT and GCE arms.

6. 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.

Recruitment & Eligibility

Status: COMPLETED

Sex: All

Target Recruitment: 45

Inclusion Criteria

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.

Exclusion Criteria

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

Study & Design

Study Type: INTERVENTIONAL

Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
General Cognitive Exercises (GCE)	Coordinated Specialty Care for First Episode Psychosis	Neuroadaptive cognitive training
Targeted Cognitive Training (TCT)	Targeted Cognitive Training	Neuroadaptive Cognitive Training
Treatment as Usual (TAU)	Coordinated Specialty Care for First Episode Psychosis	Treatment as Usual
General Cognitive Exercises (GCE)	General Cognitive Exercises	Neuroadaptive cognitive training
Targeted Cognitive Training (TCT)	Coordinated Specialty Care for First Episode Psychosis	Neuroadaptive Cognitive Training

Primary Outcome Measures

Name	Time	Method
Speed of Processing From the Measurement and Treatment Research to Improve Cognition in Schizophrenia (MATRICS) Consensus Cognitive Battery (MCCB)	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)	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)	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)	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)	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)	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)	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)	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	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 Neurobehavioral Test Battery	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	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	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)	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	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	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	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)	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)	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.

Secondary Outcome Measures

Name	Time	Method
UCSF Performance-Based Skills Assessment (UPSA): Functional Capacity	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.
Social Functioning Scale	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.
Internalized Stigma of Mental Illness (ISMI)	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.