Summary

Eligibility
for people ages 18-59 (full criteria)
Healthy Volunteers
healthy people welcome
Location
at UC Irvine
Dates
study started
study ends around

Description

Summary

In Study 2, investigators will recruit individuals with schizophrenia (SZ) and or schizoaffective disorder (SZA) and healthy controls (HC) using optimized behavioral tasks to replicate the behavioral findings from Study 1 and to assess additional psychometric properties such as test re-test reliability and practice effects.

Investigators will obtain data on: A) clinical symptoms, with detailed assessment of hallucinations and delusions; B) community functioning; and C) functional capacity, allowing us to examine clinical validity. To generate a sample with sufficient variation in hallucinations and delusions, investigators will recruit the following groups that balance feasibility with clinical relevance: A) healthy controls [HC, N=125]; B) schizophrenia and schizoaffective disorder [SZ/SZA, N=200]). Investigators anticipate a ~20% screen fail/drop-out rate based upon prior studies. Thus, investigators will run an additional 40 SZ/SZA and 15 HC.

Investigators will administer tasks optimized in Aim 1 without electroencephalogram (EEG), to this new sample of individuals with SZ/SZA and HC.

All participants will be retested after approximately 28 days and repeat clinical assessments. Although the investigators' goal is to shorten task length using the Study 1 analyses, they will administer longer tasks than optimal for public dissemination in Study 2 to determine the minimum number of trials required for acceptable reliability. Study 2 will use the same clinical and functional measures as Study 1.

Official Title

Cognitive Neurocomputational Task Reliability and Clinical Applications Consortium

Details

Each participant will complete 3 sessions (~3 hours each) within 3 weeks at baseline. The first session includes clinical, self-report, proxy function, and community function assessments. Sessions 2-3 are for task. Each participant will complete 7 tasks across these sessions. Task order will be counterbalanced across sessions. Participants will return after 28 days and repeat these same 3 sessions.

Clinical Assessment and Self-Report: A trained assessor will diagnose participants using the Structured Clinical Interview (SCID-5) for Diagnostic and Statistical Manual of Mental Disorders, 5th Edition (DSM-5) Text Revision 59 (TR59). Clinicians will rate hallucination and delusion symptom severity with the Chicago Hallucinations Assessment Tool (CHAT) and the Brief Psychiatric Rating Scale (BPRS). Investigators will use the Psychotic Symptom Rating Scales (PSYRATS) to evaluate the degree of preoccupation, conviction, distress, and life disruption associated with hallucinations and delusions elicited on the BPRS and CHAT. To address specificity, investigators will administer the Clinical Assessment Interview for Negative Symptoms (CAINS). For self-report, investigators will use the Beliefs about Voices Scale which assesses attributions about the origin and power of voices, and the Yale Control Over Perceptual Experiences (COPE) scale, which evaluates the extent to which people feel they can exert control over their voices. Investigators also will use the Peters Delusion Inventory to assess the extent of delusional thinking, supplemented by the Green Paranoia Scale to provide additional coverage of persecutory beliefs. To assess specificity, investigators will use the Patient Health Questionnaire (PHQ-9) to assess depression, the Generalized Anxiety Disorder Scale (GAD-7) to assess anxiety, and the Motivation and Pleasure Scale-Self-Report (MAP-SR) to assess anhedonia and motivation. Investigators will conduct a principal components analysis (PCA) on measures of the same construct (e.g., delusions) and perform primary analyses using the first principal component, followed by secondary analyses of specific measures False Discovery Rate (FDR) correction.

Community Function: Patients will complete the Specific Levels of Functioning (SLOF) scale, a validated scale of work and community function. National Institute of Mental Health (NIMH) Common Data Elements: Investigators will acquire the additional NIMH Tier 1 Common Data elements (e.g., World Health Organization Disability Assessment Schedule 2 (WHODAS 2.0) & DSM-5 Symptom Measure). Investigators will include standard general cognitive measures to assess the specificity of effects beyond general cognitive impairment. Specifically, investigators will include validated online measures from TestMyBrain (https://www.testmybrain.org/using-tmb/research.html; Digit Symbol Coding, Vocabulary, and Matrix Reasoning), as in our prior work in both clinical and healthy populations.

Keywords

SCHIZOPHRENIA 1 (Disorder), Schizo Affective Disorder, Healthy Adult, schizophrenia, schizo-affective, healthy controls, Psychotic Disorders, Motion Perception Task, Sine Wave Speech Task, Volatility Task, Choice Probabilistic Reversal Task, Kamin Blocking Task, Minnesota Trust Game, Dynamic Trust Game

Eligibility

You can join if…

Open to people ages 18-59

General Inclusion1)age 18 to 59 ; 2)no substance disorder in past six months (confirmed with urine drugscreens and breathalyzers); 3) no clinically significant head injury or neurological disease; 4) WechslerTest of Adult Reading (WTAR) score =16+.

Group Specific Criteria: Schizophrenia/SchizoaffectiveDisorder (SZ/SZA):

1) Diagnostic and Statistical Manual of Mental Disorders, 5th Edition (DSM-5) diagnosis ofschizophrenia or schizoaffective; 2) no medication changes in prior month or anticipated in the next month or not taking medications; 3)outpatient or partial hospital if unmedicated Healthy Controls (HC): 1)no Diagnostic and Statistical Manual of Mental Disorders, 5th Edition (DSM-5) Psychosis or BipolarDisorder; 2) no family history of psychosis or bipolar

You CAN'T join if...

Healthy Controls (HC): 1) Diagnostic and Statistical Manual of Mental Disorders, 5th Edition (DSM-5)Psychosis or Bipolar Disorder diagnosis; 2) Family history of psychosis, bipolar, or Schizophrenia/Schizoaffective Disorder (SZ/SZA): additional exclusion criteria for the unmedicated individuals are: 1) not in acute exacerbation requiring immediate hospitalization or treatment; 2) self-reported medication non-compliance for at least the four previous weeks 3)never having started medications

Locations

  • University of California Irvine
    Irvine California 92868 United States
  • University of Minnesota
    Minneapolis Minnesota 55455 United States

Details

Status
not yet accepting patients
Start Date
Completion Date
(estimated)
Sponsor
Washington University School of Medicine
ID
NCT07875790
Study Type
Interventional
Participants
Expecting 325 study participants
Last Updated