State Representation in Early Psychosis - Project 4

Schizophrenia Clinical Trial

— STEP (P4)  

Official title:

State Representation in Early Psychosis - Project 4

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05664594
• Other study ID #: STUDY00009964 (P4)
• Secondary ID: P50MH119569
• Status: Recruiting
• Phase: N/A
• Start date: July 31, 2022
• Est. completion date: March 31, 2025

Study information

• Verified date: February 2024
• Source: University of Minnesota
• Contact: Liberty Holmberg Kohler, BA
• Phone: 612-772-2201
• Email: step-phase2[@]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 15-45 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 a clinical trial examining two paradigms of cognitive training.

Description:

This is the second component of the State Representation in Early Psychosis study; the first component is reflected in NCT05273164. The 6-month follow up visit data from the first component will be used as the Baseline data for this secondary component.

In this portion of the 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, which include interviews examining behaviors and symptoms of mental health conditions, self-report questionnaires, and a neurocognitive assessment. In addition, participants will complete 2 imaging appointments, in which they will receive simultaneous EEG and fMRI while performing two 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: 200
• 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; participants aged 36-45 must have onset of psychosis within the past 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

Related Conditions & MeSH terms

• Mental Disorders
• Psychosis
• Psychotic Disorders
• Schizoaffective Disorder
• Schizophrenia
• Schizophrenia Spectrum and Other Psychotic Disorders

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, Immediately after the intervention, 5 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, Immediately after the intervention, 5 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, Immediately after the intervention, 5 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, Immediately after the intervention, 5 month follow up
Primary	Change in MRI Variables	MRI assessments will include structural MRI, Diffusion-weighted MRI, Resting State fMRI.	Baseline, Immediately after the intervention, 5 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, Immediately after the intervention, 5 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, Immediately after the intervention, 5 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, Immediately after the intervention, 5 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, Immediately after the intervention, 5 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, Immediately after the intervention, 5 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, Immediately after the intervention, 5 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, Immediately after the intervention, 5 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, Immediately after the intervention, 5 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, Immediately after the intervention, 5 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, Immediately after the intervention, 5 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, Immediately after the intervention, 5 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, Immediately after the intervention, 5 month follow up