Remote State Representation in Early Psychosis

NCT05538832 | Completed Early Phase 1

• 2 other identifiers: STUDY000208345P50MH119569
• Study Type: interventional
• Target: 152
• Locations: 1 country
• Sites: 1

Brief Summary

The purpose of this study is to examine state representation in individuals aged 18-30 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 some observational tests as well as a cognitive training clinical trial.

Conditions

Psychosis; Schizophrenia; Schizo Affective Disorder; Schizoaffective Disorder; Schizophreniform Disorders; Psychotic Disorders; Psychotic Mood Disorders; Psychoses, Affective; Psychosis Nos/Other; Schizophrenia Spectrum and Other Psychotic Disorders

Keywords

Cognitive Training; Remote; Online; Clinical Trial

Outcome Measures

Primary Outcomes (2)

• Change in Performance of Dot Pattern Expectancy (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

Secondary Outcomes (8)

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

  Baseline, Immediately after the intervention, 5 month follow up

• Change in Test My Brain Neurocognitive Assessment performance: Verbal Pair Associates Memory Z Score

  Baseline, Immediately after the intervention, 5 month follow up

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

  Baseline, Immediately after the intervention, 5 month follow up

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

  Baseline, Immediately after the intervention, 5 month follow up

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

  Baseline, Immediately after the intervention, 5 month follow up

Study Arms (2)

Visual Perception Training

EXPERIMENTAL

Contains targeted visual perception exercises from BrainHQ's suite of cognitive exercises. This training paradigm is designed to improve state estimation processes at the perceptual input level.

Device: BrainHQ Computerized Cognitive Training - Visual Perception Training Paradigm

Visual Cognitive Control Training

EXPERIMENTAL

Contains targeted visual cognitive control exercises from BrainHQ's suite of exercises. This training paradigm is designed to enhance state representation stability of visual information.

Device: BrainHQ Computerized Cognitive Training - Visual Cognitive Control Training Paradigm

Interventions

BrainHQ Computerized Cognitive Training - Visual Perception Training Paradigm DEVICE

The Cognitive Training is a program consisting of the follow set of exercises developed by Posit Science Corporation (BrainHQ) which is to be evaluated for Visual Perception Training: Visual Sweeps; Mind's Eye; Hawk Eye; and Divided Attention. Participants use a standard web browser on a broadband connected computer and go to the study web site. Participants perform multiple trials over the course of a session, with auditory/visual feedback and rewards to indicate if the trial was performed correctly or incorrectly. After each assigned session, the difficulty of the next session is updated to ensure that each participant is appropriately challenged.

Visual Perception Training

BrainHQ Computerized Cognitive Training - Visual Cognitive Control Training Paradigm DEVICE

The Cognitive Training is a program consisting of the follow set of exercises developed by Posit Science Corporation (BrainHQ) which is to be evaluated for Visual Cognitive Control Training: Mind Bender; Divided Attention; Card Shark; and Freeze Frame. Participants use a standard web browser on a broadband connected computer and go to the study web site. Participants perform multiple trials over the course of a session, with auditory/visual feedback and rewards to indicate if the trial was performed correctly or incorrectly. After each assigned session, the difficulty of the next session is updated to ensure that each participant is appropriately challenged.

Visual Cognitive Control Training

Eligibility Criteria

• Age: 18 Years - 30 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• All Participants:
• Between the ages of 18-30 at the time of screening
• Fluent in spoken and written English, in that the participant learned to speak English before the age of 12 or is able to demonstrate fluency in conversation with study staff
• Has an outpatient status and no hospitalization for psychiatric reasons for at least 1 month prior to participant
• Has access to a computer with internet connection
• Has a United States address as permanent residence
• Estimated IQ at or above 70, as estimated by the cognitive assessments
• Early Psychosis Participants:
• Diagnosis of one of the following conditions (confirmed via interview): schizophrenia; schizoaffective disorder; schizophreniform disorder; Psychosis not otherwise specified (NOS); major depressive disorder with psychotic features; bipolar disorder with psychotic features
• Willing to share contact with a clinical provider

You may not qualify if:

• All participants:
• History of severe substance use in the past 3 months (determined by interview)
• Unable to demonstrate capacity to consent to research, in the judgment of the study team
• Diagnosed with a neurological disorder that would impede participation in the study or would put the participant at additional risk by participating, in the opinion of the PI/CO-Is
• Previous clinically significant head injury or prolonged unconsciousness
• Significant cognitive training experience in the past 6 months
• Meets criteria for clinical risk of suicidal behavior.
• Non-Psychosis participants:
• Meets DSM-5 criteria for a psychotic, bipolar, or autism spectrum disorder
• Has a family history (1st degree relative) of psychosis, bipolar, or autism spectrum disorders

Sponsors & Collaborators

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

Study Sites (1)

University of Minnesota

Minneapolis, Minnesota, 55454, United States

Location

MeSH Terms

Conditions

Psychotic Disorders; Schizophrenia; Affective Disorders, Psychotic; Schizophrenia Spectrum and Other Psychotic Disorders

Condition Hierarchy (Ancestors)

Mental Disorders

Study Officials

• Caroline Demro, PhD

  University of Minnesota Department of Psychiatry and Behavioral Sciences

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: early phase 1
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Masking Details: The investigator will not know the treatment condition until the trial is completed. Participants will not be notified of which group they are assigned. The study coordinator will be aware of assignment but will not complete any outcomes assessments--these will be self-report.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 5, 2022
• First Posted: September 14, 2022
• Study Start: July 27, 2022
• Primary Completion: September 30, 2025
• Study Completion: September 30, 2025
• Last Updated: October 3, 2025

Record last verified: 2025-10

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)