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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

Timeline

Screening 3 weeks

Treatment Varies

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

Awards & highlights

STEP Trial 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.Check my eligibility

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.See study design

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.

STEP Trial 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.

STEP Trial 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

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Change in EEG Variables

Change in MRI Variables

Change in Performance of Bandit Task Variant

+2 more

Secondary outcome measures

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

STEP 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

~300

0 / 1Eligibility criteria met

Find a Location

Who is running the clinical trial?

University of MinnesotaLead Sponsor

1,380 Previous Clinical Trials

1,588,395 Total Patients Enrolled

National Institute of Mental Health (NIMH)NIH

2,786 Previous Clinical Trials

2,689,417 Total Patients Enrolled

Sophia Vinogradov, MDPrincipal InvestigatorUniversity of Minnesota

13 Previous Clinical Trials

3,100 Total Patients Enrolled

Media Library

Computerized Cognitive Training (Cognitive Training) Clinical Trial Eligibility Overview. Trial Name: NCT05273164 — N/A

Schizoaffective Disorder Research Study Groups: Perceptual Discrimination Training, Cognitive Control Training

Schizoaffective Disorder Clinical Trial 2023: Computerized Cognitive Training Highlights & Side Effects. Trial Name: NCT05273164 — N/A

Computerized Cognitive Training (Cognitive Training) 2023 Treatment Timeline for Medical Study. Trial Name: NCT05273164 — N/A

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Are there any specific qualifications for participation in this clinical research?

"This experiment is currently seeking 350 volunteers aged between 15 and 40 that have been diagnosed with schizophrenia or one of its related conditions. To be eligible for consideration, applicants must pass the following criteria: Diagnosis of a psychosis-based disorder within 5 years prior to participation, Proficiency in English language as judged by staff and self-report, Estimated IQ at least 70 based on cognitive tests conducted during screening, Maintained clinical stability through outpatient status and consistent medication dosage over 1 month before enrollment."

Answered by AI

How many participants have been included in the ongoing research?

"Affirmative. Clinicaltrials.gov data attests to the recruitment of this clinical trial, which was initially made available on December 1st 2021 and recently updated on February 28th 2022. A total of 350 individuals will be recruited from a single medical centre for the study."

Answered by AI

What primary goals are being sought by this clinical experiment?

"The aim of this clinical trial, which will be assessed across a Baseline, 6 month follow up, Immediately after the intervention and 12 month follow up time frame is to assess Change in Performance of Bandit Task Variant. Secondary outcomes include Change in Test My Brain Neurocognitive Assessment performance: Multiracial Emotion Identification Z Score (a social cognition test that evaluates one's ability to recognize emotions with higher scores indicating improved functioning), Change in symptoms and functionality as indicated by the SPQ-BR (Schizotypal Personality Questionnaire Brief Revised; ranges from 32-160, with high scores demonstrating greater schizotypy) and"

Answered by AI

Is this research opportunity available to octogenarians?

"The parameters for this trial specify that eligible patients must be between 15 and 40 years of age. On the other hand, 354 clinical trials have been created specifically for minors while 908 are designed to accommodate geriatric participants."

Answered by AI

Are there any opportunities for enrolment in this experiment?

"Yes, the information listed on clinicaltrials.gov illustrates that this medical trial is still actively recruiting individuals. The initial post date of this experiment was December 1st 2021 and it has been recently updated as late as February 28th 2022. 350 people are being sought after from a single centre for participation in the study."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

State Representation in Early Psychosis

Sophia Vinogradov 2021. "State Representation in Early Psychosis". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT05273164.

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