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 @ 5:49 PM
Ignite Modification Date:
2025-12-24 @ 5:49 PM
NCT ID:
NCT03175068
Eligibility Criteria:
Inclusion Criteria:
1. generally medically and neurologically healthy, including no evidence of mental retardation or serious cognitive impairment that would interfere with protocol adherence and/or task performance
2. between the ages of 18 - 65 years old, inclusive
3. right-handed
4. primary diagnosis of MDD or gSAD based on the SCID DSM-5. Patients will be permitted to have limited comorbid and/or history of internalizing psychopathologies (e.g., generalized anxiety disorder, specific phobia, adjustment disorder)
Exclusion Criteria:
1. personal current or past manic/hypomanic episode or psychotic symptoms
2. active suicidal ideation as determined by the Columbia Suicide Severity Rating Scale (C-SSRS)
3. prior history of standard CBT (failure or success)
4. any current or recent (past 4 weeks) use of medication (prescription or non-prescription) with psychotropic effects
5. psychotherapy other than CBT or psychotropic medication use during the study
6. cognitive dysfunction (traumatic brain injury, mental retardation, dementia)
7. active moderate or severe alcohol and/or substance use disorders
For healthy controls: history or current Axis I disorder.
Additional exclusion criteria for all participants pertaining to the fMRI scan include:
1. presence of ferrous-containing metals within the body (e.g., aneurysm clips, shrapnel/retained particles)
2. inability to tolerate small, enclosed spaces without anxiety (e.g., claustrophobia)
Healthy Volunteers:
True
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
65 Years
Study:
NCT03175068
Study Brief:
Protocol Section:
NCT03175068