Remote State Representation in Early Psychosis

Schizophrenia Clinical Trial

— Rem-STEP  

Official title:

Remote State Representation in Early Psychosis

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05538832
• Other study ID #: STUDY00015419
• Secondary ID: 5P50MH119569-02
• Status: Recruiting
• Phase: Early Phase 1
• Start date: July 27, 2022
• Est. completion date: March 31, 2025

Study information

• Verified date: July 2023
• Source: University of Minnesota
• Contact: Liberty Holmberg Kohler, BA
• Phone: 612-772-2201
• Email: remstep[@]umn.edu
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

The purpose of this study is to examine state representation in individuals aged 15-40 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 100
• Est. completion date: March 31, 2025
• Est. primary completion date: March 31, 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 30 Years

Eligibility

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)

Related Conditions & MeSH terms

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

Intervention

Device:
• 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.
• 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.

Locations

Country	Name	City	State
United States	University of Minnesota	Minneapolis	Minnesota

Sponsors (2)

Lead Sponsor	Collaborator
University of Minnesota	National Institute of Mental Health (NIMH)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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, one month follow-up post-intervention
Primary	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, one month follow-up post-intervention
Secondary	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, one month follow-up post-intervention
Secondary	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.	Baseline, one month follow-up post-intervention
Secondary	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.	Baseline, one month follow-up post-intervention
Secondary	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.	Baseline, one month follow-up post-intervention
Secondary	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.	Baseline, one month follow-up post-intervention