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 @ 7:57 PM
Ignite Modification Date:
2025-12-24 @ 7:57 PM
NCT ID:
NCT04524104
Eligibility Criteria:
Inclusion Criteria:
* 18 years of age or older at study enrollment
* Emotional distress defined by elevated depressive (PHQ9 scores 10-19) and/or anxious symptoms (GAD7 scores 10-14)
* Willing and able to provide written informed consent and HIPAA authorization
Exclusion Criteria:
* Unable to speak, read, understand English for informed consent (grade 6 level)
* Current pharmacotherapy or psychotherapy (individual or professionally-led group therapy) for depression or anxiety
* Suicidal ideation per PHQ9 with active plan
* Bipolar or psychotic disorder, or current psychiatric treatment
* Weight ≥350 pounds due to brain scanner constraints, MRI contraindications, traumatic brain injuries, and tumor or any other known structural abnormality in the brain
* Severe medical condition (e.g., myocardial infarction or stroke or new cancer diagnosis in the past 6 months, end-stage organ failure, terminal illness) or residence in a long-term care facility
* Diagnosis of cancer (other than non-melanoma skin cancer) that is/was active or treated with radiation or chemotherapy within the past year
* Active alcohol or substance use disorder (including prescription drugs) based on the CAGE Questionnaire Adapted to Include Drugs (CAGE-AID)
* Cognitive impairment based on the Callahan 6-item screener
* Current or planned pregnancy or lactating (\<6 months postpartum)
* Participation in other investigational treatment studies that would significantly affect participation in this study, raise safety concerns, and/or confound outcomes (participant may be asked to provide the informed consent of the other study for final decision on exclusion by a study psychiatrist)
* Family/household member of an already enrolled participant or of a study team member
* Plan to move out of the Chicagoland area during the study period
* Investigator discretion for clinical safety or protocol adherence reasons
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT04524104
Study Brief:
Protocol Section:
NCT04524104