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 @ 11:35 PM
Ignite Modification Date:
2025-12-24 @ 11:35 PM
NCT ID:
NCT05187156
Eligibility Criteria:
Inclusion Criteria:
Veterans will be eligible for participation if they:
* are currently enrolled in a Primary Care Clinic at VA Puget Sound Health Care System (VAPSHCS) (including Women's Clinic) or VAPSHCS Primary Care Mental Health Integration (PCMHI)
* meet criteria for clinical or subclinical PTSD consistent with PTSD treatment in PCMHI defined as \> 33 on the PTSD Checklist for DSM 5 (PCL-5)
* are willing to have therapy sessions audiotaped for the purposes of fidelity assessment
* plan to live in Washington state for 6 months following entry into the study to prevent delivery of care across state lines
Exclusion Criteria:
* presence of severe mental illness (e.g., active psychosis and/or bipolar disorder)
* a psychiatric in-patient admission in the past 30 days
* medical record suicide flag
* a behavioral flag in the medical record
* individuals with impaired decision making capacity (as measured by evidence in the medical record of moderate-severe TBI, uncontrolled psychosis, dementia, communication flag, or inability to provide informed consent)
* individuals who are illiterate or have limited or no English proficiency
* medication change in the last month
* current or recent (last 6 months) participation in specialty mental health
* current participation in CPT or PE, to ensure that Veterans are representative of PCMHI
Inclusion/exclusion criteria will be assessed via chart review.
Healthy Volunteers:
True
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT05187156
Study Brief:
Protocol Section:
NCT05187156