Clinical Trials Logo

Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT05273164
Other study ID # STUDY00009964
Secondary ID 5P50MH119569
Status Recruiting
Phase N/A
First received
Last updated
Start date December 1, 2021
Est. completion date March 31, 2025

Study information

Verified date February 2024
Source University of Minnesota
Contact Connor Petricek, BA
Phone 612-741-2826
Email Stepstudy@umn.edu
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

The purpose of this study is to examine state representation in individuals aged 15-45 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:

In the first component of this study, participants will be asked to complete two sets of appointments six months apart. During both sets of appointments, participants will be asked to complete interviews examining behaviors and symptoms of mental health conditions, self-report questionnaires, and a neurocognitive assessment. In addition, participants will complete an imaging appointment, in which they will receive simultaneous EEG and fMRI while performing two computerized tasks. The purpose of this component is to determine how failures in information processing that support state representation in neural circuits relate to clinical heterogeneity in early psychosis. To this end, the investigators will: (a) Recruit people with early psychosis and demographically similar adults without a psychiatric illness aged 15-45 years; (b) Determine test-retest reliability of variants of the DPX and Bandit tasks as assessments of state representation processes; (c) Characterize behavioral performance and neurophysiology at baseline using the DPX and Bandit task variants during simultaneous EEG-fMRI along with other MRI modalities; (d) Follow patients for 6 months while they receive usual care, to delineate their clinical trajectories; (e) Repeat the behavioral and EEG-fMRI assessments after six months. The data the investigators acquire will allow us to examine the baseline relationships between clinical and experimental measures, and also to investigate how changes in clinical and experimental measures are related over a 6-month time period during a critical phase of illness. In the second component of this study, participants will be invited to enroll in a clinical trial examining two forms of computerized cognitive training. They will be asked to complete 10 hours of training over a 3-6 week period. Upon completion of the training paradigm, they will have two additional follow up visits, a post-intervention and a 5 month follow up (which will correspond to approximately 12 months from enrollment). At both of these appointments, participants will complete the same activities completed in the first component of this project, including the interviews, questionnaires, neurocognitive assessment, and imaging combined with computerized tasks. In the second component, the investigators will recruit adults with early psychosis and demographically matched individuals without a mental health diagnosis who have completed the first component of the research. Participants will be stratified on an EEG index of state estimation processes (fronto-parietal theta power at encoding) and randomly assigned to the two training paradigms. The investigators will investigate parameter changes in the fit causal discovery analyses in each group, fit to DPX and Bandit task variant behavioral data immediately after training and 5 months later, and they will assess whether parameter changes reflect restorative or compensatory modifications. Finally, the investigators will test the hypothesis that state representation processes and cognitive performance show greater improvement in subjects who received training tailored to their state estimation parameter.


Recruitment information / eligibility

Status Recruiting
Enrollment 350
Est. completion date March 31, 2025
Est. primary completion date March 31, 2025
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 15 Years to 45 Years
Eligibility Inclusion Criteria: - English proficiency, as determined by staff observation and participant self-report - Estimated IQ at or above 70, as estimated by the cognitive assessments Additional Inclusion Criteria for Early Psychosis Participants: - Clinical diagnosis of schizophrenia, schizoaffective disorder, schizophreniform disorder, psychosis NOS, bipolar disorder with psychosis, or major depressive disorder with psychosis; those aged 36-45 years old must have had with onset of psychotic symptoms within the previous 5 years - Achieved clinical stability, defined as outpatient status for at least one month prior to study participation Exclusion Criteria: - Unable or unwilling to provide informed consent - The participant is 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 - Participant is pregnant - Participant is illiterate - Cannot pass the CMRR Subject Safety Screen due to MRI contraindications - Presence of a major neurological disorder - Previous clinically significant head injury or prolonged unconsciousness, as determined by the PI/Co-Is - Meets criteria for substance or alcohol dependence within 3 months of enrollment - The presence of any major medical condition that, in the opinion of the PI/Co-Is, would impede participation in the study or would put the participant at additional risk by participating - Presence of severe alcohol or substance abuse Additional Exclusion Criteria for Early Psychosis Participants: - Has participated in significant formal cognitive training programs, as determined by the PI/Co-Is - Meets criteria for clinical risk of suicidal behavior, as defined by: - Clinician judgement - A suicide attempt within 6 months of enrollment - Active suicidal ideation at screening or baseline, as indicated by the C-SSRS - Previous intent to act on suicidal ideation with a specific plan and/or preparatory acts within 6 months of enrollment, as indicated by the C-SSRS Additional Exclusion Criteria for Control Participants: - Meets DSM-5 criteria for psychotic, bipolar, or autism spectrum disorder - Has a family history (1st degree relative) of psychotic, bipolar, or autism spectrum disorder

Study Design


Related Conditions & MeSH terms


Intervention

Device:
Computerized Cognitive Training
Participants will complete computerized cognitive training developed by Posit Science Corporation. For a description of the training paradigms please review arm descriptions.

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, 6 month follow up, Immediately after the intervention, 12 month follow up
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, 6 month follow up, Immediately after the intervention, 12 month follow up
Primary 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, 6 month follow up, Immediately after the intervention, 12 month follow up
Primary Change in EEG Variables Analysis will examine variables including phase synchrony, slope of the spectral power density (indexing E-I balance), and prefrontal/parietal theta as a measure of perceptual noise. Baseline, 6 month follow up, Immediately after the intervention, 12 month follow up
Primary Change in MRI Variables MRI assessments will include structural MRI, Diffusion-weighted MRI, Resting State fMRI. Baseline,6 month follow up, Immediately after the intervention, 12 month follow up
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,6 month follow up, Immediately after the intervention, 12 month follow up
Secondary Change in symptoms and functioning as indicated by the SANS/SAPS The Scale for Assessment of Negative Symptoms (SANS, 25 items) and Scale for Assessment of Positive Symptoms (SAPS, 34 items) assess negative and positive symptoms of schizophrenia in a standardized interview. Scores on the SANS ranges from 0-125, and the SANS ranges from 0-170, with higher scores indicating increased symptom severity. Baseline,6 month follow up, Immediately after the intervention, 12 month follow up
Secondary Change in symptoms and functioning as indicated by the BPRS The Brief Psychiatric Rating Scale is a 24-item interview which assesses psychiatric symptoms. Scores on the BPRS rang from 24-168, with a higher score indicating increased symptom severity. Baseline,6 month follow up, Immediately after the intervention, 12 month follow up
Secondary Change in symptoms and functioning as indicated by the SPQ-BR Schizotypal Personality Questionnaire Brief Revised, a 32-item measure to assess a broad array of schizotypal symptoms and signs. The SPQ ranges from 32-160, with a higher score indicating greater schizotypy. Baseline,6 month follow up, Immediately after the intervention, 12 month follow up
Secondary Change in symptoms and functioning as indicated by the SGI The Sensory Gating Inventory Brief is a 10-item measure assesses an individual's subjective ability to modulate, filter, over-include, discriminate, attend to, and tolerate sensory stimuli. The SGI ranges from 10-60, with higher score indicating increased perceptual abnormalities. Baseline,6 month follow up, Immediately after the intervention, 12 month follow up
Secondary Change in symptoms and functioning as indicated by the IDI The Intersectional Discrimination Index is a 31-item measure assesses anticipated, day to day, and major discrimination experienced by the participant. Scores range from 0-136, with higher scores indicating greater discrimination experienced by the individual. Baseline,6 month follow up, Immediately after the intervention, 12 month follow up
Secondary Change in symptoms and functioning as indicated by the WHODAS 2.0 Brief The World Health Organization Disability Assessment Schedule is a 12-item self-administered scale measuring disability and functional impairment. The WHODAS ranges in score from 12-60, with a higher score indicating increased disability. Baseline,6 month follow up, Immediately after the intervention, 12 month follow up
Secondary Change in symptoms and functioning as indicated by the GFS/GFR The Global Functioning Social/Global Functioning Role scales provide a rating on a scale from 1-10 for social functioning and for role functioning, with higher scores indicating increased functioning. Baseline,6 month follow up, Immediately after the intervention, 12 month follow up
Secondary Change in Test My Brain Neurocognitive Assessment performance: Digit Symbol Matching Z Score This subdomain of the TMB battery assesses processing speed. Z scores range from -5 to 5, with higher score indicating increased functioning. Baseline,6 month follow up, Immediately after the intervention, 12 month follow up
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,6 month follow up, Immediately after the intervention, 12 month follow up
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,6 month follow up, Immediately after the intervention, 12 month follow up
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,6 month follow up, Immediately after the intervention, 12 month follow up
See also
  Status Clinical Trial Phase
Recruiting NCT05039489 - A Study on the Brain Mechanism of cTBS in Improving Medication-resistant Auditory Hallucinations in Schizophrenia N/A
Completed NCT05321602 - Study to Evaluate the PK Profiles of LY03010 in Patients With Schizophrenia or Schizoaffective Disorder Phase 1
Completed NCT05111548 - Brain Stimulation and Cognitive Training - Efficacy N/A
Completed NCT04503954 - Efficacy of Chronic Disease Self-management Program in People With Schizophrenia N/A
Completed NCT02831231 - Pilot Study Comparing Effects of Xanomeline Alone to Xanomeline Plus Trospium Phase 1
Completed NCT05517460 - The Efficacy of Auricular Acupressure on Improving Constipation Among Residents in Community Rehabilitation Center N/A
Completed NCT03652974 - Disturbance of Plasma Cytokine Parameters in Clozapine-Resistant Treatment-Refractory Schizophrenia (CTRS) and Their Association With Combination Therapy Phase 4
Recruiting NCT04012684 - rTMS on Mismatch Negativity of Schizophrenia N/A
Recruiting NCT04481217 - Cognitive Factors Mediating the Relationship Between Childhood Trauma and Auditory Hallucinations in Schizophrenia N/A
Completed NCT00212784 - Efficacy and Safety of Asenapine Using an Active Control in Subjects With Schizophrenia or Schizoaffective Disorder (25517)(P05935) Phase 3
Completed NCT04092686 - A Clinical Trial That Will Study the Efficacy and Safety of an Investigational Drug in Acutely Psychotic People With Schizophrenia Phase 3
Completed NCT01914393 - Pediatric Open-Label Extension Study Phase 3
Recruiting NCT03790345 - Vitamin B6 and B12 in the Treatment of Movement Disorders Induced by Antipsychotics Phase 2/Phase 3
Recruiting NCT05956327 - Insight Into Hippocampal Neuroplasticity in Schizophrenia by Investigating Molecular Pathways During Physical Training N/A
Terminated NCT03261817 - A Controlled Study With Remote Web-based Adapted Physical Activity (e-APA) in Psychotic Disorders N/A
Terminated NCT03209778 - Involuntary Memories Investigation in Schizophrenia N/A
Completed NCT02905604 - Magnetic Stimulation of the Brain in Schizophrenia or Depression N/A
Recruiting NCT05542212 - Intra-cortical Inhibition and Cognitive Deficits in Schizophrenia N/A
Completed NCT04411979 - Effects of 12 Weeks Walking on Cognitive Function in Schizophrenia N/A
Terminated NCT03220438 - TMS Enhancement of Visual Plasticity in Schizophrenia N/A