State Representation in Early Psychosis - Project 4

NCT05664594 | Completed FDA Device

• 2 other identifiers: STUDY00009964 (P4)P50MH119569
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 1

Brief Summary

The purpose of this study is to examine state representation in individuals aged 15-45 who have been diagnosed with a psychotic illness, as well as young adults who do not have a psychiatric diagnosis. State Representation is our ability to process information about our surroundings. The investigators will complete a clinical trial examining two paradigms of cognitive training. They will study the impact of the cognitive training on state representation, measured by computerized tasks, and brain activity during those tasks.

Conditions

Psychosis; Schizophrenia; Schizophrenia Spectrum and Other Psychotic Disorders; Schizoaffective Disorder

Keywords

Cognitive Training; Magnetic Resonance Imaging (MRI); Electroencephalography (EEG); State Representation

Outcome Measures

Primary Outcomes (5)

• Change in Performance of DPX Task Variant

  The DPX task variant consists of a series of pattern sequences. One pattern is designated the "A" cue, and another the "X" cue, which requires one response (AX, 60-70% of trials, e.g. respond with the left button), while other sequences require a different response (AY or BX, 12-15% of trials each, or BY, 6-10% of trials, e.g. respond with the right button). Given the strong expectation that X's evokes a valid response, BX trials place demands on the fidelity (stability, memory) of the "B" cue state representation to overcome this tendency.

  Baseline, Immediately after the intervention, 5 month follow up

• Change in Performance of Bandit Task Variant

  This is a task variant that uses choice options (neutral images) that are rewarded probabilistically. The rewarded stimulus with the highest reward is changed over time. State learning associated with staying or switching stimuli too quickly (lose-switching) can be evaluated.

  Baseline, Immediately after the intervention, 5 month follow up

• Change in Test My Brain Neurocognitive Assessment performance: Global Cognition Z Score.

  The investigators will examine global cognition scores from the Test My Brain neurocognitive battery. Z scores range from -5 to 5, with higher score indicating increased cognitive functioning.

  Baseline, Immediately after the intervention, 5 month follow up

• Change in EEG Variables

  Analysis will examine variables including phase synchrony, slope of the spectral power density (indexing E-I balance), and prefrontal/parietal theta as a measure of perceptual noise.

  Baseline, Immediately after the intervention, 5 month follow up

• Change in MRI Variables

  MRI assessments will include structural MRI, Diffusion-weighted MRI, Resting State fMRI.

  Baseline, Immediately after the intervention, 5 month follow up

Secondary Outcomes (12)

• Change in symptoms and functioning as indicated by Minnesota Symptom Severity Scale

  Baseline, Immediately after the intervention, 5 month follow up

• Change in symptoms and functioning as indicated by the SANS/SAPS

  Baseline, Immediately after the intervention, 5 month follow up

• Change in symptoms and functioning as indicated by the BPRS

  Baseline, Immediately after the intervention, 5 month follow up

• Change in symptoms and functioning as indicated by the SPQ-BR

  Baseline, Immediately after the intervention, 5 month follow up

• Change in symptoms and functioning as indicated by the SGI

  Baseline, Immediately after the intervention, 5 month follow up

Study Arms (2)

Perceptual Discrimination Training

EXPERIMENTAL

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.

Device: Computerized Cognitive Training

Visual Cognitive Control Training

EXPERIMENTAL

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.

Device: Computerized Cognitive Training

Interventions

Computerized Cognitive Training DEVICE

Participants will complete computerized cognitive training developed by Posit Science Corporation. For a description of the training paradigms please review arm descriptions.

Perceptual Discrimination Training; Visual Cognitive Control Training

Eligibility Criteria

• Age: 15 Years - 45 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• English proficiency, as determined by staff observation and participant self-report
• Estimated IQ at or above 70, as estimated by the cognitive assessments
• Clinical diagnosis of schizophrenia, schizoaffective disorder, schizophreniform disorder, psychosis NOS, bipolar disorder with psychosis, or major depressive disorder with psychosis; participants aged 36-45 must have onset of psychosis within the past 5 years
• Achieved clinical stability, defined as outpatient status for at least one month prior to study participation

You may not qualify if:

• Unable or unwilling to provide informed consent
• The participant is unable to demonstrate adequate decisional capacity, in the judgment of the consenting study staff member, to make a choice about participating in the research study
• Participant is pregnant
• Participant is illiterate
• Cannot pass the CMRR Subject Safety Screen due to MRI contraindications
• Presence of a major neurological disorder (psychosis patients may have a diagnosis of autism spectrum disorder)
• Previous clinically significant head injury or prolonged unconsciousness, as determined by the PI/Co-Is
• Meets criteria for substance or alcohol dependence within 3 months of enrollment
• The presence of any major medical condition that, in the opinion of the PI/Co-Is, would impede participation in the study or would put the participant at additional risk by participating
• Presence of severe alcohol or substance abuse
• Has participated in significant formal cognitive training programs, as determined by the PI/Co-Is
• Meets criteria for clinical risk of suicidal behavior, as defined by:
• Clinician judgement
• A suicide attempt within 6 months of enrollment
• Active suicidal ideation at screening or baseline, as indicated by the C-SSRS

Sponsors & Collaborators

• National Institute of Mental Health (NIMH): collaborator
• University of Minnesota: lead

Study Sites (1)

University of Minnesota

Minneapolis, Minnesota, 55454, United States

Location

MeSH Terms

Conditions

Psychotic Disorders; Schizophrenia; Schizophrenia Spectrum and Other Psychotic Disorders

Condition Hierarchy (Ancestors)

Mental Disorders

Study Officials

• Sophia Vinogradov, MD

  University of Minnesota

  PRINCIPAL INVESTIGATOR

• Angus MacDonald III, Ph.D.

  University of Minnesota

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: BASIC SCIENCE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 15, 2022
• First Posted: December 23, 2022
• Study Start: July 31, 2022
• Primary Completion: October 31, 2025
• Study Completion: October 31, 2025
• Last Updated: December 15, 2025

Record last verified: 2025-12

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP
• Time Frame: The data will become available 12 months after the completion of this study.
• Access Criteria: Access will be provided to users who have an account with the NIMH Data Archive and who request permission through a Data Access Request.

Locations

US (1)