- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05538832
Remote State Representation in Early Psychosis (Rem-STEP)
Study Overview
Status
Conditions
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.
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-up1, 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 patients2. 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 Type
Enrollment (Estimated)
Phase
- Early Phase 1
Contacts and Locations
Study Contact
- Name: Liberty Holmberg Kohler, BA
- Phone Number: 612-772-2201
- Email: remstep@umn.edu
Study Locations
-
-
Minnesota
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Minneapolis, Minnesota, United States, 55454
- Recruiting
- University of Minnesota
-
Contact:
- Ariel Currie, MBS
- Phone Number: 612-626-7261
- Email: curri105@umn.edu
-
Sub-Investigator:
- Sophia Vinogradov, M.D.
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Sub-Investigator:
- Angus MacDonald III, Ph.D.
-
Sub-Investigator:
- Caroline Demroe, Ph.D.
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Sub-Investigator:
- Melissa Fisher, Ph.D.
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-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Description
Inclusion Criteria:
- Diagnosis of one of the following conditions: Schizophrenia; Schizoaffective disorder; Schizophreniform disorder; Psychosis NOS; Major depressive disorder with psychotic features; or Bipolar disorder with psychotic features (confirmed with MINI 7.0 diagnostic interview)
- Between the ages of 18-30 at the time of screening
- Willing to share contact information for a clinical provider
- 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
Exclusion Criteria:
- History of severe substance use in the past 3 months (determined by the MINI 7.0 diagnostic criteria)
- 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
- Significant cognitive training experience within the last 6 months, as determined by the PI
- Diagnosed with a neurological disorder (Autism spectrum disorder is allowed)
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Double
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: 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.
|
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.
|
Experimental: 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.
|
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.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Change in Performance of DPX Task Variant
Time Frame: Baseline, one month follow-up post-intervention
|
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, one month follow-up post-intervention
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Change in Performance of Bandit Task Variant
Time Frame: Baseline, one month follow-up post-intervention
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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, one month follow-up post-intervention
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Change in Test My Brain Neurocognitive Assessment performance: Global Cognition Z Score.
Time Frame: Baseline, one month follow-up post-intervention
|
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.
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Baseline, one month follow-up post-intervention
|
Change in Test My Brain Neurocognitive Assessment performance: Verbal Pair Associates Memory Z Score
Time Frame: Baseline, one month follow-up post-intervention
|
This subdomain of the TMB battery assesses verbal learning.
Z scores range from -5 to 5, with higher score indicating increased functioning.
|
Baseline, one month follow-up post-intervention
|
Change in Test My Brain Neurocognitive Assessment performance: Matrix Reasoning Z Score
Time Frame: Baseline, one month follow-up post-intervention
|
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.
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Baseline, one month follow-up post-intervention
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Change in Test My Brain Neurocognitive Assessment performance: Multiracial Emotion Identification Z Score
Time Frame: Baseline, one month follow-up post-intervention
|
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.
|
Baseline, one month follow-up post-intervention
|
Change in symptoms and functioning as indicated by Minnesota Symptom Severity Scale
Time Frame: Baseline, one month follow-up post-intervention
|
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.
|
Baseline, one month follow-up post-intervention
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Collaborators and Investigators
Sponsor
Collaborators
Investigators
- Principal Investigator: Ian Ramsay, PhD, University of Minnesota Department of Psychiatry and Behavioral Sciences
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- STUDY00015419
- 5P50MH119569-02 (U.S. NIH Grant/Contract)
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
product manufactured in and exported from the U.S.
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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