Evaluating new PTSD assessments in military personnel and veterans
Psychometric Evaluation of the Clinician Administered PTSD Scale for DSM-5 (CAPS-5) and the PTSD Symptom Scale Interview for DSM-5 (PSSI-5) in an Active Duty and Military Veteran Sample
This study is testing two new ways to measure PTSD in military personnel and veterans to see if they are more reliable than the old method.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 950 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | U.S. Army Medical Research and Development Command Federal |
| Locations | 3 sites (Honolulu, Hawaii and 2 other locations) |
| Trial ID | NCT04180930 on ClinicalTrials.gov |
What this trial studies
This observational study aims to assess the reliability of two new PTSD assessments, the CAPS-5 and PSSI-5, in comparison to the previous gold standard, CAPS-IV. It will involve 950 active duty military and veterans who have experienced traumatic events, with participants randomized into four cohorts to evaluate test-retest reliability and convergent validity over 12 weeks. Additionally, the study will explore potential biomarkers related to PTSD to enhance understanding and inform future interventions. The research is conducted at multiple military and VA medical centers.
Who should consider this trial
Good fit: Ideal candidates include male and female active duty military personnel or veterans aged 18 and older who have experienced a qualifying traumatic event.
Not a fit: Patients currently receiving psychotherapy for PTSD or those with severe cognitive impairments may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could lead to improved assessment tools for PTSD, enhancing care for veterans and active duty military personnel.
How similar studies have performed: Previous studies have shown success in validating PTSD assessments, but the specific combination of assessments and biomarkers in this study is relatively novel.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Male or female active duty personnel or military veterans, 18 years of age or older * Competent to give informed consent * Have experienced any Criterion A qualifying traumatic event as defined by the Life Events Checklist for DSM-5 (LEC-5) * Score a 3 or above on the Primary Care-Post Traumatic Stress Disorder Screen (PC-PTSD-5) Exclusion Criteria: * Current suicidal or homicidal ideation with a plan, and substance use disorder requiring detoxification currently or in the past month as assessed using the SCID and Suicidal Ideation/Homicidal Ideation screening tool (SI/HI screen) * Assessment using CAPS or PSSI in the previous 1 year * Currently receiving psychotherapy or counseling for PTSD * Moderate to sever cognitive impairment as measured by the Montreal Cognitive Assessment (MoCA) * Meet criteria for unmedicated Bipolar I, Bipolar II, Schizophrenia, or other psychotic disorders in the last month
Where this trial is running
Honolulu, Hawaii and 2 other locations
- Tripler Army Medical Center — Honolulu, Hawaii, United States (Recruiting)
- Cincinnati VA Medical Center - Trauma Recovery Center — Fort Thomas, Kentucky, United States (Recruiting)
- Walter Reed National Military Medical Center — Bethesda, Maryland, United States (Recruiting)
Study contacts
- Principal investigator: Kathleen M Chard, PhD — Cincinnati VA Medical Center, University of Cincinnati
- Study coordinator: Savannah Noppert
- Email: savannah.noppert@va.gov
- Phone: 513-861-3100
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.