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Cognitive Neurocomputational Task Reliability and Clinical Applications Consortium: Study 2

Cognitive Neurocomputational Task Reliability and Clinical Applications Consortium

Who can join

As published by the study on ClinicalTrials.gov. "Not stated" means the study hasn't said — ask the study team.

Age
18 Years to 59 Years
Sex
All sexes
Healthy volunteers
Accepted
Compensation
Not stated

Other requirements are listed under Eligibility below. Only the study team can confirm whether you can join.

What to expect

No one can promise a trial will help you personally — that is what the research is trying to find out.

What participation involves

  • Procedures mentioned: Interviews, Questionnaires

Only what the study's summary and detailed description on ClinicalTrials.gov say. Time periods may describe the whole study or a part of it — ask the study team what applies to you.

Show the study's own words
  • "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)."
  • "To address specificity, investigators will administer the Clinical Assessment Interview for Negative Symptoms (CAINS)."
  • "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."
Compensation
Not stated
  • Study-related exams and procedures are typically provided at no cost. This is how many trials work in general — confirm the details for this study with the study team.
  • Participants are monitored closely by the research team throughout the study.
  • Some participants may receive access to an investigational treatment, which is still being studied.
  • Your participation helps researchers learn whether this approach could help future patients.

About this study

In plain language

This study tests how consistent thinking and behavior task results are when people repeat them about 28 days later. It is for adults with schizophrenia or schizoaffective disorder and healthy adults. Researchers will also look at symptoms and how people manage daily life.

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.

Compensation is read from the study's own description and may be missing — always confirm with the study team.

Eligibility

Who can join

  • Be 18 to 59 years old.
  • Have had no substance use disorder in the past 6 months, checked with urine drug tests and breath alcohol tests.
  • Have no serious head injury or disease affecting the brain or nerves.
  • Score 16 or higher on the Wechsler Test of Adult Reading.
  • For the schizophrenia group: have a diagnosis of schizophrenia or schizoaffective disorder.
  • For the schizophrenia group: have no medicine changes in the past month or planned for the next month, or take no medicine.
  • For people in the schizophrenia group who take no medicine: receive outpatient care or partial hospital care, without an overnight stay.
  • For healthy adults: have no personal or family history of psychosis or bipolar disorder. Psychosis affects a person's sense of what is real; bipolar disorder causes major shifts in mood.

Who can't join

  • Healthy adults cannot have a diagnosis or family history of psychosis or bipolar disorder.
  • The listing gives unclear extra rules for people with schizophrenia or schizoaffective disorder who take no medicine. Ask the study team how urgent treatment needs, missed medicine in the past 4 weeks, or never starting medicine affect eligibility.

Simplified for readability. The official criteria below are what the study team uses.

Official eligibility criteria

Inclusion Criteria: 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 Exclusion Criteria: 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

Study sites (5)

CA

IL

MD

MN

MO