Schizophrenia Clinical Trial
— Rem-STEPOfficial title:
Remote State Representation in Early Psychosis
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.
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) |
Country | Name | City | State |
---|---|---|---|
United States | University of Minnesota | Minneapolis | Minnesota |
Lead Sponsor | Collaborator |
---|---|
University of Minnesota | National Institute of Mental Health (NIMH) |
United States,
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 |
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