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 @ 6:37 PM
Ignite Modification Date:
2025-12-24 @ 6:37 PM
NCT ID:
NCT03056157
Eligibility Criteria:
Inclusion Criteria:
1. Served in an active-duty role within the military since September 2001 (Veterans may be eligible whether or not they were deployed to a warzone)
2. Met the DSM-5 diagnostic criteria for PTSD as a result of military trauma (per Clinician Administered PTSD Scale for DSM-5 \[CAPS-5\]) and reported non-negligible levels of associated functional impairment (Sheehan Disability Scale \[SDS\] score = 10)
3. Prospective enrollees must have been willing to commit to 12 consecutive weekly therapy sessions lasting up to 90 minutes in duration and to complete assessment materials.
Exclusion Criteria:
1. Bipolar or psychotic disorders.
2. Current drug or alcohol dependence (other than caffeine or tobacco dependence). Prospective enrollees who had maintained sobriety for at least 6 weeks immediately prior to the time of enrollment may have been eligible.
3. Evidence of traumatic brain injury severe enough to influence the ability to understand and respond to study procedures
4. Suicidal or homicidal ideation severe enough to warrant immediate attention
5. Concurrent enrollment in any treatment that involves: (1) systematic disclosure of troubling trauma-related memories or (2) present-focused psychosocial skills training for PTSD or (3) supportive therapy/case management on a \> monthly basis or (4) any individual therapy or (5) newly (\< 6 weeks) prescribed pharmacological treatment.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT03056157
Study Brief:
Protocol Section:
NCT03056157