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:
2026-03-26 @ 3:19 PM
Ignite Modification Date:
2026-03-26 @ 3:19 PM
NCT ID:
NCT07351305
Eligibility Criteria:
Inclusion Criteria:
1. Ability of participant to understand and the willingness to sign a written informed consent document based on interviewer assessment and clinical judgement.
2. Any veteran or active duty service member (age 18 or above) diagnosed with mild or moderate TBI as determined by the Ohio State University Brain Injury Identification Method
3. Participant meets diagnostic criteria for PTSD based on Clinician-Administered PTSD Scale (CAPS-5) interview as described by the National Center for PTSD which includes at least one Criterion B symptom, one Criterion C symptom, two Criterion D symptoms, and two Criterion E symptoms as well as meeting Criterions F and G.
4. Ability to read, write, and speak English based on interviewer assessment and clinical judgement.
Exclusion Criteria:
1. Participant is actively engaged in a behavioral intervention primarily targeting PTSD.
2. Participant has a psychiatric problem that warrants immediate treatment as indicated in the electronic health record, flagged during testing, or confirmed by a clinician through screening or review of clinical notes.
3. Participant demonstrates significant cognitive impairment that could impact treatment adherence/benefit based on interviewer assessment and clinical judgement.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT07351305
Study Brief:
Protocol Section:
NCT07351305