Clinical trial NCT05538832: Remote State Representation in Early Psychosis
Official title: Remote State Representation in Early Psychosis
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: EARLY_PHASE1
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
Keywords: Cognitive Training
Remote
Online
Clinical Trial
Lead sponsor: University of Minnesota
Sponsor class: OTHER
Collaborators: name: National Institute of Mental Health (NIMH)
First posted: 2022-09-14
Enrollment: 100
Sex: ALL
Minimum age (years): 18
Maximum age (years): 30
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Eligibility criteria: INCLUSION CRITERIA

All Participants:

1. Between the ages of 18-30 at the time of screening
2. 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
3. Has an outpatient status and no hospitalization for psychiatric reasons for at least 1 month prior to participant
4. Has access to a computer with internet connection
5. Has a United States address as permanent residence

   Early Psychosis Participants:
6. 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
7. Willing to share contact with a clinical provider

EXCLUSION CRITERIA

All participants:

1. History of severe substance use in the past 3 months (determined by interview)
2. Unable to demonstrate capacity to consent to research, in the judgment of the study team
3. Diagnosed with a neurological disorder
4. Previous clinically significant head injury or prolonged unconsciousness
5. Significant cognitive training experience in the past 6 months
6. Meets criteria for clinical risk of suicidal behavior.

   Non-Psychosis participants:
7. Meets DSM-5 criteria for a psychotic, bipolar, or autism spectrum disorder
8. Has a family history (1st degree relative) of psychosis, bipolar, or autism spectrum disorders

Primary outcomes:
measure: Change in Performance of DPX Task Variant
timeFrame: Baseline, one month follow-up post-intervention
measure: Change in Performance of Bandit Task Variant
timeFrame: Baseline, one month follow-up post-intervention
Secondary outcomes:
measure: Change in Test My Brain Neurocognitive Assessment performance: Global Cognition Z Score.
timeFrame: Baseline, one month follow-up post-intervention
measure: Change in Test My Brain Neurocognitive Assessment performance: Verbal Pair Associates Memory Z Score
timeFrame: Baseline, one month follow-up post-intervention
measure: Change in Test My Brain Neurocognitive Assessment performance: Matrix Reasoning Z Score
timeFrame: Baseline, one month follow-up post-intervention
measure: Change in Test My Brain Neurocognitive Assessment performance: Multiracial Emotion Identification Z Score
timeFrame: Baseline, one month follow-up post-intervention
measure: Change in symptoms and functioning as indicated by Minnesota Symptom Severity Scale
timeFrame: Baseline, one month follow-up post-intervention
Other outcomes:
Locations:
city: Minneapolis
country: United States
facility: University of Minnesota
state: Minnesota
Study officials:
affiliation: University of Minnesota Department of Psychiatry and Behavioral Sciences
name: Caroline Demro, PhD
role: PRINCIPAL_INVESTIGATOR
References: