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Cognitive Training

Computerized Cognitive Training for Psychosis (STEP (P4) 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

Be younger than 65 years old

Timeline

Screening 3 weeks

Treatment Varies

Follow Up baseline, immediately after the intervention, 5 month follow up

Awards & highlights

No Placebo-Only Group

Summary

This trial will examine how people with/without psychotic illness process information about their environment and if cognitive training can help.

Who is the study for?

This trial is for individuals aged 15-40 with a recent diagnosis of psychosis or related conditions, who speak English and have an IQ above 70. They must be clinically stable, not pregnant, non-dependent on substances, and without major medical or neurological issues.

What is being tested?

The study is testing two types of computerized cognitive training designed to improve information processing in young adults with psychotic illnesses compared to those without psychiatric diagnoses.

What are the potential side effects?

Since the intervention involves cognitive training exercises, side effects are minimal but may include eye strain, headache or fatigue from computer use.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ baseline, immediately after the intervention, 5 month follow up

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~baseline, immediately after the intervention, 5 month follow up

This trial's timeline: 3 weeks for screening, Varies for treatment, and baseline, immediately after the intervention, 5 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

Group I: Visual Cognitive Control TrainingExperimental Treatment1 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.

Group II: 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.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Computerized Cognitive Training

2019

N/A

~410

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