Remote State Representation in Early Psychosis

NCT ID: NCT05538832

Last Updated: 2025-10-03

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: EARLY_PHASE1
• Total Enrollment: 152 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2022-07-27
• Study Completion Date: 2025-09-30

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.

Detailed Description

The purpose of the current study is to investigate computationally-informed precision treatments to improve two forms of state representation dysfunction observed in psychosis: 1) Abnormal perceptual inputs that impair state estimation; or, 2) Reduced state representation stability that affects cognitive control, working memory, and behavioral outputs. We will test the effects of two forms of cognitive training: visual perception training or visual cognitive control training in individuals with early psychosis. Participants will have the option to complete all training and assessments entirely remotely. We will recruit both young adults who have been diagnosed with a psychosis spectrum illness (such as schizophrenia) as well as individuals without a history of psychosis to participate in this study.

Early psychosis can manifest low-level perceptual deficits (such as an abnormal mismatch negativity response); these perceptual abnormalities are observed in ~60% of individuals, where they are predictive of more severe disability at 12 month follow-up, consistent with multiple studies showing that perceptual input abnormalities, when present, have a widespread deleterious downstream impact. Psychotic disorders can also manifest deficits in working memory, consistent with dysfunctional state representation stability, seen in ~80% of patients. Thus, psychosis is heterogeneous in its underlying information processing pathology and clinical course, indicating a critical unmet need for precision treatment approaches.

We will address this unmet need by investigating the behavioral and neurophysiologic effects of a brief course of either visual perception training (designed to improve state estimation processes at the perceptual input level) or visual cognitive control training (designed to enhance state representation stability of visual information), in individuals with psychotic disorders such as schizophrenia, schizoaffective disorder, and bipolar disorder with psychosis. Because study visits may be conducted remotely, participants will be drawn from a national sample. Our goal is not to perform a treatment efficacy study comparing these two interventions. Rather, we seek to use predictions derived from basic and computational neuroscience to test the effects of neuroplasticity-based precision treatments targeting two distinct contributing information processing pathologies in psychosis, with the goal of improving state representation processes and cognition.

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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

Visual Perception Training

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.

Group Type: EXPERIMENTAL

BrainHQ Computerized Cognitive Training - Visual Perception Training Paradigm

Intervention Type: 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 Cognitive Control Training

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.

Group Type: EXPERIMENTAL

BrainHQ Computerized Cognitive Training - Visual Cognitive Control Training Paradigm

Intervention Type: 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.

Interventions

BrainHQ Computerized Cognitive Training - Visual Perception Training Paradigm

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.

Intervention Type: DEVICE

BrainHQ Computerized Cognitive Training - Visual Cognitive Control Training Paradigm

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.

Intervention Type: DEVICE

Eligibility Criteria

Inclusion Criteria

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

Exclusion Criteria

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 30 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

National Institute of Mental Health (NIMH)

NIH

Sponsor Role: collaborator

University of Minnesota

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Caroline Demro, PhD

Role: PRINCIPAL_INVESTIGATOR

University of Minnesota Department of Psychiatry and Behavioral Sciences

Locations

University of Minnesota

Minneapolis, Minnesota, United States

Countries

United States

Other Identifiers

5P50MH119569

Identifier Type: NIH

Identifier Source: secondary_id

View Link

STUDY00020834

Identifier Type: -

Identifier Source: org_study_id