Clinical trial Recruiting at 3 sites Observational Ages 18 and up

Evaluating new PTSD assessments in military personnel and veterans

Official title: 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

Run by U.S. Army Medical Research and Development Command · NCT04180930 · Data updated 2026-11-12

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.

More Stress Disorders, Post-Traumatic trials

Quick facts

Study typeObservational
Ages18 Years and up
SexAll
Enrollment950 (estimated)
SponsorU.S. Army Medical Research and Development Command
Federal
Locations3 sites (Honolulu, Hawaii and 2 other locations)
StatusRecruiting
StartedApril 15, 2019
Main results expectedJune 30, 2025
Study endsJune 30, 2025
Registry record updatedJanuary 23, 2025
Trial IDNCT04180930 on ClinicalTrials.gov

Is this trial a fit for you?

Likely a 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.

Probably not a fit

Patients currently receiving psychotherapy for PTSD or those with severe cognitive impairments may not benefit from this study.

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

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.

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 gone: Previous studies have shown success in validating PTSD assessments, but the specific combination of assessments and biomarkers in this study is relatively novel.

Who can join: the full rules

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 it's running

  • 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

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How to take part

  1. Review the eligibility criteria above with your treating physician.
  2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
  3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.
Last reviewed 2026-11-14 by the Find a Trial editorial team. Information on this page is for educational purposes and is not medical advice. Always consult qualified healthcare professionals about clinical trial participation.