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 @ 9:56 PM
Ignite Modification Date:
2025-12-24 @ 9:56 PM
NCT ID:
NCT05112432
Eligibility Criteria:
Inclusion Criteria:
* Enrolled in EPI-MINN: Measurement Based Care protocol, STUDY00009334
* Good general health (i.e. not acutely ill or experiencing a severe/chronic illness that would impede their ability to complete study activities. This determination shall be, if necessary, made at the discretion of the PIs)
* Estimated IQ at or above 70, as estimated by the Penn CNP Matrix Reasoning Test
* Achieved clinical stability, defined as outpatient status for at least one month prior to study participation and clinically stable doses of psychiatric medication (by PI discretion) for at least one month prior to study participation (including no medication)
* Has access to a smartphone or other mobile device to use the PRIME app
Exclusion Criteria:
* Under legal commitment to treatment or is under medical guardianship, and there is no provision in the guardianship order or a court order to allow the guardian to consent to participation in research
* Participated in significant cognitive training programs within the last three years
* Diagnosed with a neurological disorder (Autism Spectrum Disorder is allowed)
* Clinically significant substance abuse that is impeding the participant's abulity to participate fully during recruitment, enrollment, assessment, or training, (is unable to remain sober for assessments and training)
* Risk of suicidal behavior, as indicated by the clinicall obtained C-SSRS or clinician judgement. Risk of suicidal behavior is defined as:
* Active suicidal ideation at screening or baseline, or
* Previous intent to act on suicidal ideation with a specific plan, preparatory acts, or an actual suicide attempt within the last 3 months
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
15 Years
Maximum Age:
40 Years
Study:
NCT05112432
Study Brief:
Protocol Section:
NCT05112432