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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
STEP (P4) Trial 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.Check my eligibility
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.See study design
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.
STEP (P4) Trial 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
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 moreSecondary 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 moreSTEP (P4) 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
~300
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Who is running the clinical trial?
University of MinnesotaLead Sponsor
1,379 Previous Clinical Trials
1,588,296 Total Patients Enrolled
11 Trials studying Psychosis
1,425 Patients Enrolled for Psychosis
National Institute of Mental Health (NIMH)NIH
2,784 Previous Clinical Trials
2,689,077 Total Patients Enrolled
46 Trials studying Psychosis
10,519 Patients Enrolled for Psychosis
Sophia Vinogradov, MDPrincipal InvestigatorUniversity of Minnesota
13 Previous Clinical Trials
3,250 Total Patients Enrolled
8 Trials studying Psychosis
1,500 Patients Enrolled for Psychosis
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Eligibility Criteria:
This trial includes the following eligibility criteria:- I was diagnosed with a psychosis-related disorder and am between 36-45 years old with symptoms starting in the last 5 years.I do not have, nor does my immediate family have, a history of psychotic, bipolar, or autism spectrum disorders.I have a significant neurological condition.I have been stable and out of the hospital for at least one month.I am considered capable of making decisions about joining this study.I have been stable and not hospitalized for at least a month and on a steady dose of psychiatric meds for the same time.I was diagnosed with a psychotic disorder within the last 5 years.
Research Study Groups:
This trial has the following groups:- Group 1: Perceptual Discrimination Training
- Group 2: Visual Cognitive Control Training
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Are participants under 50 years of age eligible for this research study?
"As outlined in the inclusion criteria for this research project, prospective participants must be between 15 and 40 years of age."
Answered by AI
Who can participate in this research endeavor?
"The criteria for this clinical trial necessitate that applicants possess psychosis and are aged between 15 to 40 years. Around 200 participants will be admitted into the study."
Answered by AI
Are there any remaining vacancies for participants in this trial?
"Clinicaltrials.gov states that this trial is currently recruiting patients; it was initially listed on the 31st of July 2022 and recently updated on December 15th, 2020."
Answered by AI
What is the current participation rate of this clinical investigation?
"Precisely, clinicaltrials.gov indicates that this medical experiment is actively enlisting patients. This trial was originally posted on July 31st 2022 and has been recently revised on December 15th 2022. 200 participants are being recruited from 1 centre."
Answered by AI
What are the expected results of this experiment?
"The primary purpose of this scientific inquiry, which will be evaluated at various intervals such as Baseline, Immediately after the intervention and 5 Month follow up is to assess any changes in Global Cognition Z Score performance using Test My Brain Neurocognitive Assessment. To glean a holistic understanding of symptom change and functioning alterations during the study period secondary outcomes including Scale for Assessment of Negative Symptoms (SANS), Scale for Assessment of Positive Symptoms (SAPS), Brief Psychiatric Rating Scale (BPRS) and Sensory Gating Inventory Brief's SGI scores are also being tracked."
Answered by AI
Who else is applying?
What state do they live in?
Minnesota
What site did they apply to?
University of Minnesota
What portion of applicants met pre-screening criteria?
Met criteria
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