PsychosisEarly Phase 1Rem-STEPNCT05538832
Remote State Representation in Early Psychosis
A Early Phase 1 study testing BrainHQ Computerized Cognitive Training - Visual Perception Training Paradigm in people with Psychosis and Schizophrenia, run by University of Minnesota at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 30 yearsHealthy volunteers can take part
- Conditions the study is for
- Psychosis, Schizophrenia, Schizo Affective Disorder
- What is being tested?
- BrainHQ Computerized Cognitive Training - Visual Perception Training Paradigm
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 152 participants
- Where
- 1 siteUnited States
- Study dates
- 27 Jul 2022to 30 Sep 2025
- Phase
- Early Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 30 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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
Show all 10Show fewer
- 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
Who cannot join
- 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
Show all 10Show fewer
- 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
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Minnesota
Minneapolis, Minnesota, 55454
About this study
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.
Read the 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
- Being tested
- BrainHQ Computerized Cognitive Training - Visual Perception Training Paradigm, BrainHQ Computerized Cognitive Training - Visual Cognitive Control Training Paradigm
- Keywords
- Cognitive Training, Remote, Online, Clinical Trial
- Medical subject headings
- Psychotic Disorders, Schizophrenia, Affective Disorders, Psychotic, Schizophrenia Spectrum and Other Psychotic Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
BrainHQ Computerized Cognitive Training - Visual Perception Training ParadigmDevice
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.
BrainHQ Computerized Cognitive Training - Visual Cognitive Control Training ParadigmDevice
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Device: BrainHQ Computerized Cognitive Training - Visual Cognitive Control Training Paradigm |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: Baseline, Immediately after the intervention, 5 month follow up
Secondary outcomes (8)
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.
Measured: Baseline, Immediately after the intervention, 5 month follow up
Change in Test My Brain Neurocognitive Assessment performance: Verbal Pair Associates Memory Z Score
This subdomain of the TMB battery assesses verbal learning. Z scores range from -5 to 5, with higher score indicating increased functioning.
Measured: Baseline, Immediately after the intervention, 5 month follow up
Change in Test My Brain Neurocognitive Assessment performance: Matrix Reasoning Z Score
This subdomain of the TMB battery assesses reasoning skills and also provides an IQ estimate. Z scores range from -5 to 5, with higher score indicating increased functioning.
Measured: Baseline, Immediately after the intervention, 5 month follow up
Change in Test My Brain Neurocognitive Assessment performance: Multiracial Emotion Identification Z Score
This subdomain of the TMB battery is a social cognition test that assesses the ability to recognize emotions (happiness, sadness, anger, and fear). Z scores range from -5 to 5, with higher score indicating increased functioning.
Measured: Baseline, Immediately after the intervention, 5 month follow up
Change in symptoms and functioning as indicated by Minnesota Symptom Severity Scale
This 29-item measure assesses symptoms in several domains such as anxiety, depression, sleep problems, somatic symptoms, and substance use. Scores range from 0 to 116, with a higher score indicating greater symptom severity.
Measured: Baseline, Immediately after the intervention, 5 month follow up
Change in symptoms and functioning as indicated by the SANS/SAPS
The Scale for Assessment of Negative Symptoms (SANS, 25 items) and Scale for Assessment of Positive Symptoms (SAPS, 34 items) assess negative and positive symptoms of schizophrenia in a standardized interview. Scores on the SANS ranges from 0-125, and the SANS ranges from 0-170, with higher scores indicating increased symptom severity.
Measured: Baseline, Immediately after the intervention, 5 month follow up
Change in symptoms and functioning as indicated by the BPRS
The Brief Psychiatric Rating Scale is a 24-item interview which assesses psychiatric symptoms. Scores on the BPRS rang from 24-168, with a higher score indicating increased symptom severity.
Measured: Baseline, Immediately after the intervention, 5 month follow up
Change in symptoms and functioning as indicated by the GFS/GFR
The Global Functioning Social/Global Functioning Role scales provide a rating on a scale from 1-10 for social functioning and for role functioning, with higher scores indicating increased functioning.
Measured: Baseline, Immediately after the intervention, 5 month follow up
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Sep 2022
- Study start27 Jul 2022
- Primary completion30 Sep 2025
- Study completion30 Sep 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for PsychosisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Early Phase 1
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 152 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Minnesota
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute of Mental Health (NIMH)
- Responsible party
- Sponsor
- Investigators
- Caroline Demro, PhD, Principal investigator, University of Minnesota Department of Psychiatry and Behavioral Sciences
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05538832
- Sponsor's protocol ID
- STUDY00020834
- Other IDs
- 5P50MH119569
- Acronym
- Rem-STEP
- Status last verified
- Oct 2025
- First submitted
- 5 Aug 2022
- Last updated
- 3 Oct 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 3 Oct 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Remote State Representation in Early Psychosis
- ClinicalTrials.gov ID
- NCT05538832
- Acronym / sponsor ID
- Rem-STEP / STUDY00020834
- Conditions
- Psychosis, Schizophrenia, Schizo Affective Disorder, Schizoaffective Disorder, Schizophreniform Disorders, Psychotic Disorders
- Keywords
- Cognitive Training, Remote, Online, Clinical Trial
- Phase
- Early Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 152 participants (actual)
- Lead sponsor
- University of MinnesotaUniversity, hospital or other
- Collaborators
- National Institute of Mental Health (NIMH)
- Study start
- 27 Jul 2022 (actual)
- Primary completion
- 30 Sep 2025 (actual)
- Study completion
- 30 Sep 2025 (actual)
- First posted
- 14 Sep 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Visual Perception Training | Experimental | Device: BrainHQ Computerized Cognitive Training - Visual Perception Training ParadigmContains 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. |
| Visual Cognitive Control Training | Experimental | Device: BrainHQ Computerized Cognitive Training - Visual Cognitive Control Training ParadigmContains targeted visual cognitive control exercises from BrainHQ's suite of exercises. This training paradigm is designed to enhance state representation stability of visual information. |
Who may qualify
- Ages
- 18 to 30 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (10 listed)
- 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
Key exclusion criteria (10 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| BrainHQ Computerized Cognitive Training - Visual Perception Training ParadigmThe 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. | Device | Visual Perception Training |
| BrainHQ Computerized Cognitive Training - Visual Cognitive Control Training ParadigmThe 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. | Device | Visual Cognitive Control Training |
Primary outcome
Change in Performance of Dot Pattern Expectancy (DPX) Task Variant
Time frame: Baseline, Immediately after the intervention, 5 month follow up
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.
Change in Performance of Bandit Task Variant
Time frame: Baseline, Immediately after the intervention, 5 month follow up
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.
8 secondary outcomes
Change in Test My Brain Neurocognitive Assessment performance: Global Cognition Z Score.
Time frame: Baseline, Immediately after the intervention, 5 month follow up
Change in Test My Brain Neurocognitive Assessment performance: Verbal Pair Associates Memory Z Score
Time frame: Baseline, Immediately after the intervention, 5 month follow up
Change in Test My Brain Neurocognitive Assessment performance: Matrix Reasoning Z Score
Time frame: Baseline, Immediately after the intervention, 5 month follow up
Change in Test My Brain Neurocognitive Assessment performance: Multiracial Emotion Identification Z Score
Time frame: Baseline, Immediately after the intervention, 5 month follow up
Change in symptoms and functioning as indicated by Minnesota Symptom Severity Scale
Time frame: Baseline, Immediately after the intervention, 5 month follow up
Change in symptoms and functioning as indicated by the SANS/SAPS
Time frame: Baseline, Immediately after the intervention, 5 month follow up
Change in symptoms and functioning as indicated by the BPRS
Time frame: Baseline, Immediately after the intervention, 5 month follow up
Change in symptoms and functioning as indicated by the GFS/GFR
Time frame: Baseline, Immediately after the intervention, 5 month follow up
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Oct 2025.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Caroline Demro, PhD principal investigator
University of Minnesota Department of Psychiatry and Behavioral Sciences
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Early Phase 1 study testing BrainHQ Computerized Cognitive Training - Visual Perception Training Paradigm in people with Psychosis and Schizophrenia, run by University of Minnesota at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 10 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 3 Oct 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Early Phase 1 (sometimes called Phase 0) studies give a very small amount of a treatment to a few people, mainly to see how the body handles it.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in Performance of Dot Pattern Expectancy (DPX) Task Variant (time frame: Baseline, Immediately after the intervention, 5 month follow up). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Oct 2025.