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Remote State Representation in Early Psychosis (Rem-STEP)

Primary Purpose

Psychosis, Schizophrenia, Schizo Affective Disorder

Status
Recruiting
Phase
Early Phase 1
Locations
United States
Study Type
Interventional
Intervention
BrainHQ Computerized Cognitive Training - Visual Perception Training Paradigm
BrainHQ Computerized Cognitive Training - Visual Cognitive Control Training Paradigm
Sponsored by
University of Minnesota
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Psychosis focused on measuring Cognitive Training, Remote, Online, Clinical Trial

Eligibility Criteria

18 Years - 30 Years (Adult)All SexesDoes not accept healthy volunteers

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 18-45 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)

Sites / Locations

  • University of MinnesotaRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Experimental

Arm Label

Visual Perception Training

Visual Cognitive Control Training

Arm Description

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.

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.

Outcomes

Primary Outcome Measures

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.
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.

Secondary Outcome Measures

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.
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.
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.
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.
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.

Full Information

First Posted
August 5, 2022
Last Updated
July 11, 2023
Sponsor
University of Minnesota
Collaborators
National Institute of Mental Health (NIMH)
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1. Study Identification

Unique Protocol Identification Number
NCT05538832
Brief Title
Remote State Representation in Early Psychosis
Acronym
Rem-STEP
Official Title
Remote State Representation in Early Psychosis
Study Type
Interventional

2. Study Status

Record Verification Date
July 2023
Overall Recruitment Status
Recruiting
Study Start Date
July 27, 2022 (Actual)
Primary Completion Date
March 31, 2025 (Anticipated)
Study Completion Date
March 31, 2025 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University of Minnesota
Collaborators
National Institute of Mental Health (NIMH)

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Product Manufactured in and Exported from the U.S.
No
Data Monitoring Committee
No

5. Study Description

Brief 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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
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

7. Study Design

Primary Purpose
Treatment
Study Phase
Early Phase 1
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Masking Description
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.
Allocation
Randomized
Enrollment
100 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Visual Perception Training
Arm Type
Experimental
Arm Description
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.
Arm Title
Visual Cognitive Control Training
Arm Type
Experimental
Arm Description
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.
Intervention Type
Device
Intervention Name(s)
BrainHQ Computerized Cognitive Training - Visual Perception Training Paradigm
Intervention Description
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
Intervention Name(s)
BrainHQ Computerized Cognitive Training - Visual Cognitive Control Training Paradigm
Intervention Description
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.
Primary Outcome Measure Information:
Title
Change in Performance of DPX Task Variant
Description
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.
Time Frame
Baseline, one month follow-up post-intervention
Title
Change in Performance of Bandit Task Variant
Description
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.
Time Frame
Baseline, one month follow-up post-intervention
Secondary Outcome Measure Information:
Title
Change in Test My Brain Neurocognitive Assessment performance: Global Cognition Z Score.
Description
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.
Time Frame
Baseline, one month follow-up post-intervention
Title
Change in Test My Brain Neurocognitive Assessment performance: Verbal Pair Associates Memory Z Score
Description
This subdomain of the TMB battery assesses verbal learning. Z scores range from -5 to 5, with higher score indicating increased functioning.
Time Frame
Baseline, one month follow-up post-intervention
Title
Change in Test My Brain Neurocognitive Assessment performance: Matrix Reasoning Z Score
Description
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.
Time Frame
Baseline, one month follow-up post-intervention
Title
Change in Test My Brain Neurocognitive Assessment performance: Multiracial Emotion Identification Z Score
Description
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.
Time Frame
Baseline, one month follow-up post-intervention
Title
Change in symptoms and functioning as indicated by Minnesota Symptom Severity Scale
Description
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.
Time Frame
Baseline, one month follow-up post-intervention

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
30 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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)
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Liberty Holmberg Kohler, BA
Phone
612-772-2201
Email
remstep@umn.edu
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Ian Ramsay, PhD
Organizational Affiliation
University of Minnesota Department of Psychiatry and Behavioral Sciences
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of Minnesota
City
Minneapolis
State/Province
Minnesota
ZIP/Postal Code
55454
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Ariel Currie, MBS
Phone
612-626-7261
Email
curri105@umn.edu
First Name & Middle Initial & Last Name & Degree
Sophia Vinogradov, M.D.
First Name & Middle Initial & Last Name & Degree
Angus MacDonald III, Ph.D.
First Name & Middle Initial & Last Name & Degree
Melissa Fisher, Ph.D.
First Name & Middle Initial & Last Name & Degree
Caroline Demroe, Ph.D.

12. IPD Sharing Statement

Learn more about this trial

Remote State Representation in Early Psychosis

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