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:
2025-12-25 @ 2:54 AM
Ignite Modification Date:
2025-12-25 @ 2:54 AM
NCT ID:
NCT03764033
Eligibility Criteria:
Inclusion Criteria:
* Veterans 18-82 years of age
* Veterans who meet Diagnostic and Statistical Manual of Mental Disorders, Fifth Edition (DSM-5) criteria for Post-traumatic Stress Disorder (PTSD) or score 23 or higher on the Clinician-Administered PTSD Scale for DSM-5 (CAPS) screening interview.
* Veterans who endorsed killing or being responsible for the death of another in a war zone and report continued distress regarding these events
* Distress will be operationalized by a positive response to one or more of the nine self-directed moral injury items on the Expressions of Moral Injury Scale-Military Version (EMIS-M) or item #4 on the Moral Injury Events Scale (MIES)
* Veterans who have initiated or completed an evidence-based treatment for PTSD, such as Cognitive Processing Therapy (CPT) or Prolonged Exposure (PE)
* If receiving CPT or PE, Veterans must complete treatment and wait two weeks prior to screening
* If receiving prescription medication for PTSD, Veterans must be one month stable on medication and not make any changes to medication during the course of the active treatment phase of the study
Exclusion Criteria:
* Veterans with current or lifetime diagnosis of a psychotic disorder or current untreated/unmanaged mania.
* Veterans with recent suicidal or homicidal behaviors (chronic suicidal ideation is not exclusionary)
* Veterans with recent psychiatric hospitalizations
* Veterans with moderate or severe alcohol or drug dependence within the past three months
* Veterans receiving individual therapy for PTSD or those planning to start skills-based or trauma-focused group psychotherapy will be excluded
* However, these Veterans will be offered the opportunity to be screened again after completion of individual PTSD therapy or once they are three months stable in group treatment, with no plans to discontinue this treatment
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
82 Years
Study:
NCT03764033
Study Brief:
Protocol Section:
NCT03764033