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 @ 10:42 PM
Ignite Modification Date:
2025-12-24 @ 10:42 PM
NCT ID:
NCT04257435
Eligibility Criteria:
Inclusion Criteria:
* Documented mild TBI or moderate TBI.
* Individual is recommended to have a Behavioral Health provider at ISC Fort Belvoir for general TBI-related psychological impairments.
* Individual has decision making capacity for informed consent based on medical provider clinical judgement and initial evaluation.
* Individual scored a 14 or lower on the Patient Health Questionnaire-9, indicating no worse than moderate depressive symptoms.
* Individual is 18 years or older.
* Individual is Defense Enrollment Eligibility Reporting System-eligible.
Exclusion Criteria:
* Individuals with severe depressive symptoms (PHQ-9 score above 14).
* Documented severe traumatic brain injury.
* Minors and pediatric populations.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT04257435
Study Brief:
Protocol Section:
NCT04257435