Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-24 @ 2:54 PM
Ignite Modification Date:
2025-12-24 @ 2:54 PM
NCT ID:
NCT01561859
Eligibility Criteria:
Inclusion Criteria:
Patients will be included if they have:
1. a diagnosis of schizophrenia or schizoaffective disorder verified by the SCID (in our data patients with both conditions respond similarly to CET);
2. duration since first psychotic symptom of \< 10 years;
3. stable positive symptoms based on medical record review and SCID for at least 2 months;
4. are currently maintained on and compliant with prescribed antipsychotic medication;
5. age 18-55 years;
6. significant social and cognitive disability based on the Cognitive Style and Social Cognition Eligibility Interview utilized in previous CET studies;
7. current IQ \>= 80; and
8. the ability to read (sixth grade level or higher) and speak fluent English. This is a study of early course schizophrenia, not first-episode schizophrenia. A duration of illness since first psychotic symptom of \< 10 years is adequate to define the early phase of the illness, particularly given that the average duration of untreated psychosis is a year or more. Eligibility criteria regarding IQ are justified from previous experience with CET indicating that individuals with severe mental incapacity are better served with less cognitively advanced programs.
Exclusion Criteria:
In order to avoid confounders likely to affect cognition and limit response to cognitive rehabilitation, we will exclude those with:
1. significant neurological or medical disorders that may produce cognitive impairment (e.g., seizure disorder, traumatic brain injury);
2. persistent suicidal or homicidal behavior;
3. a recent (within the past 3 months) history of substance abuse or dependence; and
4. any MRI contraindications such as ferromagnetic objects in the body.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
55 Years
Study:
NCT01561859
Study Brief:
Protocol Section:
NCT01561859