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Cognitive Training

Computerized Cognitive Training for Psychosis (STEP Trial)

N/A

Recruiting

Led By Sophia Vinogradov, MD

Research Sponsored by University of Minnesota

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Achieved clinical stability, defined as outpatient status for at least one month prior to study participation

Be younger than 65 years old

Must not have

Presence of a major neurological disorder

Has a family history (1st degree relative) of psychotic, bipolar, or autism spectrum disorder

Timeline

Screening 3 weeks

Treatment Varies

Follow Up baseline,6 month follow up, immediately after the intervention, 12 month follow up

Awards & highlights

No Placebo-Only Group

Summary

This trial will examine how well people with psychotic illnesses and young adults without psychiatric diagnoses process information about their surroundings. Observation and cognitive tests will be conducted.

Who is the study for?

This trial is for individuals aged 15-40 who have been diagnosed with psychotic illnesses like schizophrenia, and also for young adults without psychiatric diagnoses. Participants must speak English, have an IQ of 70 or above, and be able to give informed consent. Pregnant individuals, those with major neurological disorders or medical conditions that could interfere with the study, recent substance dependence cases, or significant head injuries are excluded.

What is being tested?

The study is testing how well people can process information about their surroundings (state representation) using observational tests and computerized cognitive training. It includes both individuals with psychotic illnesses and healthy young adults to compare results.

What are the potential side effects?

Since this trial involves observational tests and non-invasive computerized cognitive training, there are minimal expected side effects. However, discomfort from sitting during long sessions or potential stress from test-taking may occur.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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I have been stable and out of the hospital for at least one month.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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I have a significant neurological condition.

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A close family member has had psychosis, bipolar disorder, or autism.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ baseline,6 month follow up, immediately after the intervention, 12 month follow up

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~baseline,6 month follow up, immediately after the intervention, 12 month follow up

This trial's timeline: 3 weeks for screening, Varies for treatment, and baseline,6 month follow up, immediately after the intervention, 12 month follow up for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Change in EEG Variables

Change in MRI Variables

Change in Performance of Bandit Task Variant

+2 more

Secondary study objectives

Change in Test My Brain Neurocognitive Assessment performance: Digit Symbol Matching Z Score

Change in Test My Brain Neurocognitive Assessment performance: Matrix Reasoning Z Score

Change in Test My Brain Neurocognitive Assessment performance: Multiracial Emotion Identification Z Score

+9 more

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

2Treatment groups

Experimental Treatment

Active Control

Group I: Perceptual Discrimination TrainingExperimental Treatment1 Intervention

Training will involve Gabor patch and other visual stimuli discrimination exercises that focus on improving signal-to-noise resolution and attentional control with minimal working memory/cognitive control effects. On each training trial, participants are required to distinguish a target stimulus among a set of distractor stimuli. The similarity between target and distractors increases in level of difficulty based on an adaptive perceptual processing staircase function. Consecutive correct responses lead to increased modulation of the distractors to be more similar to the target, while 1 incorrect response drops the user to an easier level. Difficulty is adapted to maintain an 80% correct response rate. Each session will consist of 4 exercises requiring \~45 minutes. with 40 trials for each exercise.

Group II: Cognitive Control TrainingActive Control1 Intervention

Training will involve maintaining accurate representations of cognitive context (the "rule") in working memory during response selection. On each training trial, participants must observe stimuli, and hold the correct response context "on-line" in order to select the correct response from among the stimuli. Training is adaptive using a staircase function, such that two consecutive correct responses increases either the speed of stimuli presentation or the working memory load via an increased number of stimuli that are presented; one incorrect response reduces the cognitive load. Each session will consist of 45 exercises requiring \~45 minutes.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Computerized Cognitive Training

2019

N/A

~410

0 / 3Eligibility criteria met