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Cognitive Neurocomputational Task Reliability & Clinical Applications Consortium (CNTRACS): Study 1

Cognitive Neurocomputational Task Reliability & 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 seven thinking tasks in adults with schizophrenia or schizoaffective disorder and healthy adults. It looks at how well the tasks predict hallucinations (seeing or hearing things that are not there), delusions (strong false beliefs), and daily functioning. Researchers will also use EEG, a test that records brain activity.

In Study 1, investigators will test the ability of each of the seven paradigms to differentiate between schizophrenia (SZ)/schizoaffective disorder (SZA) and matched healthy control subjects (HC) and to predict individual differences in clinical measures of hallucinations and delusions (as well as measures of function). Investigators will also directly compare the tasks in terms of predictive ability and psychometric properties and determine whether the tasks share variance or explain unique variance. This will include determining whether hallucinations and delusions are best explained by separate underlying processes or by a single process. Investigators will also test whether the model-based parameters from these studies are more precise and sensitive than standard behavioral methods for assessing deficits across psychotic disorders and for predicting hallucinations and delusions (Aim 1). Investigators will also validate key model-based parameters against well-characterized neurophysiological measures using electroencephalogram (EEG) (Aim 4). The data from Study 1 will also be used to optimize (e.g., length, floor, and ceiling effects) tasks for Study 2. 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) \[HC, N=125\]; B) schizophrenia and schizoaffective disorder \[SZ/SZA, N=200\]). For Study 1, investigators will ensure that 40 patients are unmedicated. Investigators anticipate a \~20% screen fail/drop-out rate based on our prior Cognitive Neuroscience Test Reliability and Clinical Applications for Schizophrenia Consortium (CNTRACS) studies. Thus, investigators will run an additional 40 SZ/SZA and 15 HC. All sites have experience recruiting patients in each of these groups as indicated by our past successful studies, and the fact that investigators have been able to recruit patients with significant hallucinations and delusions in all groups. Investigators will also validate key model-based parameters against well-characterized neurophysiological measures using electroencephalogram (EEG) (Aim 4). The data from Study 1 will also be used to optimize (e.g., length, floor, and ceiling effects) tasks for Study 2. 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) \[HC, N=125\]; B) schizophrenia and schizoaffective disorder \[SZ/SZA, N=200\]). For Study 1, investigators will ensure that 40 patients are unmedicated. Investigators anticipate a \~20% screen fail/drop-out rate based on our prior Cognitive Neuroscience Test Reliability and Clinical Applications for Schizophrenia Consortium (CNTRACS) studies. Thus, investigators will run an additional 40 SZ/SZA and 15 HC. All sites have experience recruiting patients in each of these groups as indicated by our past successful studies, and the fact that investigators have been able to recruit patients with significant hallucinations and delusions in all groups.

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 no substance use disorder in the past 6 months, checked with urine drug tests and breath alcohol tests.
  • Have no major head injury or disease of the brain or nerves.
  • Score at least 16 on the Wechsler Test of Adult Reading, a reading test.
  • For the patient group: have a diagnosis of schizophrenia or schizoaffective disorder.
  • For the patient group: have no medicine changes in the past month or planned for the next month, or take no medicine.
  • For patients taking no medicine: receive outpatient or partial hospital care, rather than full-time hospital care.
  • For healthy adults: have no personal or family history of psychosis (trouble knowing what is real) or bipolar disorder (extreme mood changes).

Who can't join

  • Healthy adults: a diagnosis of psychosis or bipolar disorder.
  • Healthy adults: a family history of psychosis or bipolar disorder.
  • Rules for patients taking no medicine are unclear in the listing. It lists no sudden worsening needing urgent hospital care or treatment, not taking medicine as prescribed for at least 4 weeks, and never starting medicine. Ask the study team how these rules apply.

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

Official eligibility criteria

Inclusion Criteria: General Inclusion 1. age 18 to 59 2. no substance disorder in past six months (confirmed with urine drug screens and breathalyzers); 3. no clinically significant head injury or neurological disease. 4. Wechsler Test of Adult Reading (WTAR) score =16+. Group Specific Criteria: Schizophrenia/Schizoaffective Disorder (SZ): 1. Diagnostic and Statistical Manual of Mental Disorders, 5th Edition (DSM-5) diagnosis of schizophrenia 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 Bipolar Disorder; 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 or bipolar 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